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Sample records for cancer pilot study

  1. Photoacoustic analysis of thyroid cancer in vivo: a pilot study

    NASA Astrophysics Data System (ADS)

    Kim, Jeesu; Kim, Min-Hee; Jo, Kwanhoon; Ha, Jeonghoon; Kim, Yongmin; Lim, Dong-Jun; Kim, Chulhong

    2017-03-01

    Thyroid cancer is one of the most prevalent cancers. About 3-8% of the people in the United States have thyroid nodules, and 5-15% of these nodules are malignant. Fine-needle aspiration biopsy (FNAB) is a standard procedure to diagnose malignity of nodules. However, about 10-20% of FNABs produce indeterminable results, which leads to repeat biopsies and unnecessary surgical operations. We have explored photoacoustic (PA) imaging as a new method to identify cancerous nodules. In a pilot study to test its feasibility, we recruited patients with thyroid nodules (currently 36 cases with 21 malignant and 15 benign nodules), acquired in vivo PA and ultrasound (US) images of the nodules in real time using a recently-developed clinical PA/US imaging system, and analyzed the acquired data offline. The preliminary results show that malignant and benign nodules could be differentiated by utilizing their PA amplitudes at different excitation wavelengths. This is the first in vivo PA analysis of thyroid nodules. Although a larger-scale study is needed for statistical significance, the preliminary results show the good potential of PA imaging as a non-invasive tool for triaging thyroid cancer.

  2. A Mobile Breast Cancer Survivorship Care App: Pilot Study.

    PubMed

    Baseman, Janet; Revere, Debra; Baldwin, Laura-Mae

    2017-09-26

    Cancer survivors living in rural areas experience unique challenges due to additional burdens, such as travel and limited access to specialists. Rural survivors of breast cancer have reported poorer outcomes, poorer mental health and physical functioning, and lower-than-average quality of life compared to urban survivors. To explore the feasibility and acceptability of developing a mobile health survivorship care app to facilitate care coordination; support medical, psychosocial, and practical needs; and improve survivors' long-term health outcomes. An interactive prototype app, SmartSurvivor, was developed that included recommended survivorship care plan components. The prototype's feasibility and acceptability were tested by a sample of breast cancer survivors (n=6), primary care providers (n=4), and an oncologist (n=1). Overall, both survivors and providers felt that SmartSurvivor was a potentially valuable tool to support long-term survivorship care plan objectives. Portability, accessibility, and having one place for all contact, treatment, symptom tracking, and medication summaries was highly valued. Our pilot study indicates that SmartSurvivor is a feasible and acceptable approach to meeting survivorship care objectives and the needs of both breast cancer survivors and their health care providers. Exploration of mobile health options for supporting survivorship care plan needs is a promising area of research.

  3. Cancer, Employment, and American Indians: A Participatory Action Research Pilot Study

    ERIC Educational Resources Information Center

    Johnson, Sharon R.; Finifrock, DeAnna; Marshall, Catherine A.; Jaakola, Julia; Setterquist, Janette; Burross, Heidi L.; Hodge, Felicia Schanche

    2011-01-01

    American Indian cancer survivors are an underserved and understudied group. In this pilot study we attempted to address, through participatory action research, missing information about those factors that serve to either facilitate employment or hinder it for adult cancer survivors. One task of the study was to develop and/or modify…

  4. Cancer, Employment, and American Indians: A Participatory Action Research Pilot Study

    ERIC Educational Resources Information Center

    Johnson, Sharon R.; Finifrock, DeAnna; Marshall, Catherine A.; Jaakola, Julia; Setterquist, Janette; Burross, Heidi L.; Hodge, Felicia Schanche

    2011-01-01

    American Indian cancer survivors are an underserved and understudied group. In this pilot study we attempted to address, through participatory action research, missing information about those factors that serve to either facilitate employment or hinder it for adult cancer survivors. One task of the study was to develop and/or modify…

  5. Incidence of cancer among Nordic airline pilots over five decades: occupational cohort study

    PubMed Central

    Pukkala, Eero; Aspholm, Rafael; Auvinen, Anssi; Eliasch, Harald; Gundestrup, Maryanne; Haldorsen, Tor; Hammar, Niklas; Hrafnkelsson, Jón; Kyyrönen, Pentti; Linnersjö, Anette; Rafnsson, Vilhjálmur; Storm, Hans; Tveten, Ulf

    2002-01-01

    Objective To assess the incidence of cancer among male airline pilots in the Nordic countries, with special reference to risk related to cosmic radiation. Design Retrospective cohort study, with follow up of cancer incidence through the national cancer registries. Setting Denmark, Finland, Iceland, Norway, and Sweden. Participants 10 032 male airline pilots, with an average follow up of 17 years. Main outcome measures Standardised incidence ratios, with expected numbers based on national cancer incidence rates; dose-response analysis using Poisson regression. Results 466 cases of cancer were diagnosed compared with 456 expected. The only significantly increased standardised incidence ratios were for skin cancer: melanoma 2.3 (95% confidence interval 1.7 to 3.0), non-melanoma 2.1 (1.7 to 2.8), basal cell carcinoma 2.5 (1.9 to 3.2). The relative risk of skin cancers increased with the estimated radiation dose. The relative risk of prostate cancer increased with increasing number of flight hours in long distance aircraft. Conclusions This study does not indicate a marked increase in cancer risk attributable to cosmic radiation, although some influence of cosmic radiation on skin cancer cannot be entirely excluded. The suggestion of an association between number of long distance flights (possibly related to circadian hormonal disturbances) and prostate cancer needs to be confirmed. What is already known on this topicAirline pilots are occupationally exposed to cosmic radiation and other potentially carcinogenic elementsIn the studies published so far, dose-response patterns have not been characterisedWhat this study addsNo marked risk of cancer attributable to cosmic radiation is observed in airline pilotsA threefold excess of skin cancers is seen among pilots with longer careers, but the influence of recreational exposure to ultraviolet light cannot be quantifiedA slight increase in risk of prostate cancer with increasing number of long haul flights suggests a need

  6. Food Insecurity Among Cancer Patients in Kentucky: A Pilot Study

    PubMed Central

    Simmons, Leigh Ann; Modesitt, Susan C.; Brody, Amanda C.; Leggin, Allison B.

    2006-01-01

    Purpose Food insecurity is defined as being uncertain of having enough food due to insufficient money or other resources. The purpose of this study was to examine the construct and correlates of food insecurity in a sample of cancer patients in Kentucky. Patients and Methods Data were collected in the waiting rooms of the chemotherapy, hematology/oncology, and gynecology/oncology clinics of a university cancer center, and included 115 cancer patients actively receiving treatment (mean age, 55.85 years; range, 23 to 88 years) who completed a series of standardized measures to assess food insecurity status and psychological and nutritional well-being. Descriptive statistics and independent samples t tests were used to assess the prevalence of food insecurity in the sample, and to identify differences between the persons who were food insecure and food secure. Results The prevalence rates of food insecurity and food insecurity with hunger in the sample were 17.4% and 7.8%, respectively, which are higher than in the general population. Food-insecure patients had statistically significant higher levels of nutritional risk, depression, and financial strain, and lower quality of life compared with food secure patients. Fifty-five percent of food insecure patients reported not taking a prescribed medication because they could not afford it, versus 12.8% of food-secure patients (P = .002). Conclusion Food insecurity may be an important consideration for clinical oncology practice, especially when caring for individuals of lower socioeconomic status. Further study is warranted, including prospective studies of cancer patients to identify causal relationships among food insecurity, cancer incidence, cancer treatments, and patient outcomes and well-being. PMID:20859354

  7. A pilot study of an intervention for breast cancer survivors and their spouses.

    PubMed

    Shields, Cleveland G; Rousseau, Sally J

    2004-03-01

    Recent studies have shown that interventions that increase breast cancer patients' communication with family members lead to reduced patient distress. In this article, we report on a treatment development and pilot study of an intervention for couples coping with breast cancer. In phase 1 of this study, 10 couples participated in two focus groups that generated ideas and themes for the intervention. In phase 2, we developed and pilot tested our intervention with 48 couples: 12 in a 2-session format, 21 in a 1-session format, and 15 in a non-experimental control group. Our response rate shows that breast cancer patients and spouses were willing to participate and that treatment providers were willing to refer patients and their spouses. The 2-session format showed the most promise for producing positive change in mental health functioning and cancer-related stress.

  8. Pilot Study of a Clinical Pathway Implementation in Rectal Cancer

    PubMed Central

    Uña, Esther; López-Lara, Francisco

    2010-01-01

    Background: Rectal cancer is a highly prevalent disease which needs a multidisciplinary approach to be treated. The absence of specific protocols implies a significant and unjustifiable variability among the different professionals involved in this disease. The purpose is to develop a clinical pathway based on the analysis process and aims to reduce this variability and to reduce unnecessary costs. Methods: We created a multidisciplinary team with contributors from every clinical area involved in the diagnosis and treatment in this disease. We held periodic meetings to agree on a protocol based on the best available clinical practice guidelines. Once we had agreed on the protocol, we implemented its use as a standard in our institution. Every patient older than 18 years who was diagnosed with rectal cancer was considered a candidate to be treated via the pathway. Results: We evaluated 48 patients during the course of this study. Every parameter measured was improved after the implementation of the pathway, except the proportion of patients with 12 nodes or more analysed. The perception that our patients had about this project was very good. Conclusions: Clinical pathways are needed to improve the quality of health care. This kind of project helps reduce hospital costs and optimizes the use of limited resources. On the other hand, unexplained variability is also reduced, with consequent benefits for the patients. PMID:21151842

  9. Laughter and Stress Relief in Cancer Patients: A Pilot Study

    PubMed Central

    Kim, S. H.; Kim, Y. H.; Kim, H. J.

    2015-01-01

    The purpose of this study was to examine the effect of a therapeutic laughter program and the number of program sessions on anxiety, depression, and stress in breast cancer patients. A randomized controlled trial was conducted involving 31 patients who received four sessions of therapeutic laughter program comprised and 29 who were assigned to the no-program control group. Scores for anxiety, depression, and stress were measured using an 11-point numerical rating scale. While no change was detected in the control group, the program group reported reductions of 1.94, 1.84, and 2.06 points for anxiety, depression, and stress, respectively (p < 0.01, p < 0.01, and p < 0.01). Scores decreased significantly after the first therapeutic laughter session (p < 0.05, p < 0.01, and p < 0.01). As the therapeutic laughter program was effective after only a single session in reducing anxiety, depression, and stress in breast cancer patients, it could be recommended as a first-line complementary/alternative therapy. PMID:26064177

  10. Laughter and Stress Relief in Cancer Patients: A Pilot Study.

    PubMed

    Kim, S H; Kim, Y H; Kim, H J

    2015-01-01

    The purpose of this study was to examine the effect of a therapeutic laughter program and the number of program sessions on anxiety, depression, and stress in breast cancer patients. A randomized controlled trial was conducted involving 31 patients who received four sessions of therapeutic laughter program comprised and 29 who were assigned to the no-program control group. Scores for anxiety, depression, and stress were measured using an 11-point numerical rating scale. While no change was detected in the control group, the program group reported reductions of 1.94, 1.84, and 2.06 points for anxiety, depression, and stress, respectively (p < 0.01, p < 0.01, and p < 0.01). Scores decreased significantly after the first therapeutic laughter session (p < 0.05, p < 0.01, and p < 0.01). As the therapeutic laughter program was effective after only a single session in reducing anxiety, depression, and stress in breast cancer patients, it could be recommended as a first-line complementary/alternative therapy.

  11. Assessing cancer survivors' needs using web-based technology: a pilot study.

    PubMed

    Lavoie Smith, Ellen M; Skalla, Karen; Li, Zhongze; Onega, Tracy; Rhoda, June; Gates, Charlene; Litterini, Amy; Scott, Mary R

    2012-02-01

    Development of cancer survivor resources has been hampered by lack of knowledge regarding survivors' needs. The main study aim was to pilot test a Web-based cancer survivor needs assessment survey. The second aim was to pilot three sampling approaches. This cross-sectional study was conducted at the Norris Cotton Cancer Center and nine community-based clinics serving urban and rural populations. Population-based and convenience sampling approaches were used to recruit 547 participants over 4 months. Participants completed a Web-based cancer survivor needs assessment survey. Respondents were mainly white (98%), married (71%) women (80%) with a college education (96%). Although most (66%) (n = 362) had been diagnosed with breast cancer, other cancer diagnoses were represented. Participants reported fatigue (47%), forgetfulness (39%), joint pain (34%), anxiety (31%), trouble sleeping (28%), peripheral neuropathy (27%), inflexibility (23%), and weight gain (23%). Survivors with nonbreast solid tumor malignancies reported more problems than those with breast or hematologic malignancies (P range = .037 to <.0001). Most survivors requested assistance for losing weight (74.2%), decreasing fatigue (50%), and improving flexibility (69.3%), sleep (68.5%), and memory (60.2%). Results supported that cancer survivors struggle with many enduring problems. Web-based technology will facilitate future exploration of unmet needs.

  12. Lung cancer correlates in Lebanese adults: a pilot case--control study.

    PubMed

    Aoun, Joseph; Saleh, Nadine; Waked, Mirna; Salamé, Joseph; Salameh, Pascale

    2013-12-01

    Lung cancer is one of the most prevalent types of cancers. However, there are no epidemiological studies concerning lung cancer and its risk factors in Lebanon. This study was carried out to determine the association between lung cancer and its most common risk factors in a sample of the Lebanese population. A hospital-based case-control study was conducted. Patients were recruited in a tertiary health care center. A questionnaire in Arabic was designed to assess the possible risk factors for lung cancer. For females, cigarette smoking (ORa=9.76) and using fuel for heating (ORa=9.12) were found to be the main risk factors for lung cancer; for males, cigarette smoking (ORa=156.98), living near an electricity generator (ORa=13.26), consuming low quantities of fruits and vegetables (ORa=10.54) and a family history of cancer (ORa=8.75) were associated with lung cancer. Waterpipe smoking was significantly correlated with lung cancer in the bivariate analysis. In this pilot study, it was found that in addition to smoking, outdoor and indoor pollution factors were potential risk factors of lung cancer. Additional studies would be necessary to confirm these findings. Copyright © 2013 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd. All rights reserved.

  13. Yoga as palliation in women with advanced cancer: a pilot study.

    PubMed

    Carr, Tracey; Quinlan, Elizabeth; Robertson, Susan; Duggleby, Wendy; Thomas, Roanne; Holtslander, Lorraine

    2016-03-01

    The purpose of this pilot study was to investigate the palliative potential of home-based yoga sessions provided to women with advanced cancer. Personalised 45-minute yoga sessions were offered to three women with advanced cancer by an experienced yoga teacher. Each woman took part in a one-to-one interview after the completion of the yoga programme and was asked to describe her experiences of the programme's impact. The personalised nature of the yoga sessions resulted in similar positive physical and psychosocial effects comparable to those demonstrated in other studies with cancer patients. Participants described physical, mental, and emotional benefits as well as the alleviation of illness impacts. The enhancement of mind-body and body-spirit connections were also noted. Personalised home-based yoga programmes for people with advanced cancer may produce similar benefits, including palliation, as those institutionally-based programmes for people with non-advanced cancer.

  14. Exploring the views of patients with cancer on what makes a good nurse--a pilot study.

    PubMed

    Gallagher, Ann; Horton, Khim; Tschudin, Verena; Lister, Sara

    2009-06-16

    This article presents and discusses findings from a qualitative pilot study that surveyed patients with cancer to discover their views on what makes a good nurse. Ten outpatients at a U.K. specialist cancer hospital, who had received inpatient treatment for cancer, were interviewed. The interview data was analysed thematically and four themes identified: good nurse virtues; knowledge; skill; and, organisational culture.

  15. Therapeutic horseback riding in breast cancer survivors: a pilot study.

    PubMed

    Cerulli, Claudia; Minganti, Carlo; De Santis, Chiara; Tranchita, Eliana; Quaranta, Federico; Parisi, Attilio

    2014-08-01

    To evaluate the physiologic and psychological effects of an equine-assisted therapy protocol (EAT) in breast cancer survivors. Twenty women (mean age, 45.61±2.71 years) whose breast cancer treatment had concluded at least 6 months previously underwent a screening protocol to certify their eligibility to participate in noncompetitive sports. The patients were randomly assigned to an intervention group (n=10) or a control group (n=10). Intervention patients participated in a 16-week EAT protocol consisting of 2 hours of activity per week. All patients were tested before and after the intervention for maximal oxygen consumption (VO2max), fat mass percentage, total body water percentage, strength of principal muscular groups (measured on five weight-lifting machines [leg press, leg extension, leg curl, shoulder press, vertical traction]), and quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire (FACIT-F). After intervention, the intervention group showed an improvement in VO2max (28.29%; p<.001), a decrease in fat mass percentage (change, -7.73%; p<0.002), an increase in total body water percentage (6.90%; p=0.027), and an increase in strength (leg press, 17.75% [p=0.018]; leg extension, 21.55% [p=0.005]; leg curl, 26.04% [p<0.001]; shoulder press, 49.72% [p=0.003]; vertical traction, 19.27% [p=0.002]). Furthermore, the increase in the three FACIT-F scores (FACIT-F trial outcome: 9.29% [p=0.010]; Functional Assessment of Cancer Therapy-General total score, 14.80% [p=0.022]; FACIT-F total score, 11.48% [p=0.004]) showed an increase in quality of life. No significant changes for any variable were found for the control group. EAT had positive effects on both physiologic and psychological measures, enhancing quality of life of breast cancer survivors. RESULTS suggest a new method for rehabilitation intervention strategies after cancer in a nonmedical environment.

  16. Participation of Asian-American women in cancer treatment research: a pilot study.

    PubMed

    Nguyen, Tung T; Somkin, Carol P; Ma, Yifei; Fung, Lei-Chun; Nguyen, Thoa

    2005-01-01

    Few Asian-American women participate in cancer treatment trials. In a pilot study to assess barriers to participation, we mailed surveys to 132 oncologists and interviewed 19 Asian-American women with cancer from Northern California. Forty-four oncologists responded. They reported as barriers language problems, lack of culturally relevant cancer information, and complex protocols. Most stated that they informed Asian-American women about treatment trials. Only four women interviewed knew about trials. Other patient-identified barriers were fear of side effects, language problems, competing needs, and fear of experimentation. Family decision making was a barrier for both oncologists and patients. Compared to non-Asian oncologists, more Asian oncologists have referred Asian-American women to industry trials and identified barriers similar to patients' reports. Our findings indicate that Asian-American women need to be informed about cancer treatment trials, linguistic barriers should be addressed, and future research should evaluate cultural barriers such as family decision making.

  17. Excessive adiposity and sedentary lifestyles are prevalent in cancer patients; a pilot study.

    PubMed

    Almeida, Ana Isabel; João, Dina Raquel; Rolão, Andreia; Monteiro-Grillo, Isabel; Camilo, Maria; Ravasco, Paulo

    2013-01-01

    Cancer aetiology is multifactorial; risk factors comprise obesity, central adiposity, physical inactivity and excessive/ deficient intake of foods and/or nutrients with procarcinogenic/ protective effects. We aim to analyze the pattern of nutritional status, food intake and physical activity in a cohort of cancer patients. This pilot crosssectional study was conducted in 64 outpatients referred for Radiotherapy. Nutritional parameters evaluated: BMI, waist circumference, body composition by tetrapolar bioimpedance (Xitron®). Usual food intake was collected with a short food frequency questionnaire and physical activity was assessed with Jacksons' questionnaire. Overweight/obesity and excessive body fat mass prevalence was of 53% and 61%, respectively. Central obesity, which indicates moderate/high cardio-metabolic risk, was found in 78% of patients. Food frequency analysis showed a poor intake in vegetables and a high intake in meat and carbohydrates. Physical inactivity was prevalent. This pilot study in cancer patients, showed a high prevalence of overweight/obesity, excessive fat mass and central obesity, simultaneously with sedentary lifestyles and an inadequate diet, poor in protective foods and excessive in deleterious ones. Thus, these patients exhibit a high risk pattern for cancer development and for a poorer prognosis. The implementation of measures to promote balanced and protective diets and to encourage physical activity practice is urgently needed.

  18. Amino Acid Profiles of Serum and Urine in Search for Prostate Cancer Biomarkers: a Pilot Study.

    PubMed

    Dereziński, Paweł; Klupczynska, Agnieszka; Sawicki, Wojciech; Pałka, Jerzy A; Kokot, Zenon J

    2017-01-01

    There is a great interest in searching for diagnostic biomarkers in prostate cancer patients. The aim of the pilot study was to evaluate free amino acid profiles in their serum and urine. The presented paper shows the first comprehensive analysis of a wide panel of amino acids in two different physiological fluids obtained from the same groups of prostate cancer patients (n = 49) and healthy men (n = 40). The potential of free amino acids, both proteinogenic and non-proteinogenic, as prostate cancer biomarkers and their utility in classification of study participants have been assessed. Several metabolites, which deserve special attention in the further metabolomic investigations on searching for prostate cancer markers, were indicated. Moreover, free amino acid profiles enabled to classify samples to one of the studied groups with high sensitivity and specificity. The presented research provides a strong evidence that ethanolamine, arginine and branched-chain amino acids metabolic pathways can be a valuable source of markers for prostate cancer. The altered concentrations of the above-mentioned metabolites suggest their role in pathogenesis of prostate cancer and they should be further evaluated as clinically useful markers of prostate cancer.

  19. Association between Echinococcus granulosus infection and cancer risk - a pilot study in Cyprus.

    PubMed

    Oikonomopoulou, Katerina; Yu, Herbert; Wang, Zhanwei; Vasiliou, Stella K; Brinc, Davor; Christofi, Georgios; Theodorou, Marilena; Pavlou, Pavlos; Hadjisavvas, Andreas; Demetriou, Christiana A; Kyriacou, Kyriacos; Diamandis, Eleftherios P

    2016-12-01

    Infections from microorganisms and parasites have been connected with either increased or decreased cancer risk. The objective of this study was to investigate whether infection by Echinococcus granulosus is associated with cancer risk. We assembled a pilot retrospective cohort of patients who were diagnosed as being infected by E. granulosus in Cyprus between 1930 and 2011. Age/gender-matched non-infected family members and neighbors were selected as references. Medical history was ascertained from each study subject through in-person interview. Cox proportional hazards regression analysis was performed to assess the association of being infected by E. granulosus with cancer risk. Individuals with prior infection by E. granulosus (n=249) were more likely to have cancer compared to those without infection (n=753), 11.65% vs. 8.37% (p=0.0492). Survival analysis also showed that subjects with prior infection had a higher risk for developing cancer. The hazards ratio (HR) was 1.595, [95% confidence interval (CI) between 1.008 and 2.525]. The risk ratio did not change significantly (HR=1.536; 95% CI: 0.965-2.445) after adjusting for gender, year of birth, smoking status, alcohol consumption, and family history of cancer. Our study suggests that infection by E. granulosus may increase cancer risk. If this observation can be confirmed independently, further investigation of the mechanisms underlying the association is warranted.

  20. Amino Acid Profiles of Serum and Urine in Search for Prostate Cancer Biomarkers: a Pilot Study

    PubMed Central

    Dereziński, Paweł; Klupczynska, Agnieszka; Sawicki, Wojciech; Pałka, Jerzy A.; Kokot, Zenon J.

    2017-01-01

    There is a great interest in searching for diagnostic biomarkers in prostate cancer patients. The aim of the pilot study was to evaluate free amino acid profiles in their serum and urine. The presented paper shows the first comprehensive analysis of a wide panel of amino acids in two different physiological fluids obtained from the same groups of prostate cancer patients (n = 49) and healthy men (n = 40). The potential of free amino acids, both proteinogenic and non-proteinogenic, as prostate cancer biomarkers and their utility in classification of study participants have been assessed. Several metabolites, which deserve special attention in the further metabolomic investigations on searching for prostate cancer markers, were indicated. Moreover, free amino acid profiles enabled to classify samples to one of the studied groups with high sensitivity and specificity. The presented research provides a strong evidence that ethanolamine, arginine and branched-chain amino acids metabolic pathways can be a valuable source of markers for prostate cancer. The altered concentrations of the above-mentioned metabolites suggest their role in pathogenesis of prostate cancer and they should be further evaluated as clinically useful markers of prostate cancer. PMID:28138303

  1. Treatment of Lymphedema with Saam Acupuncture in Patients with Breast Cancer: A Pilot Study

    PubMed Central

    Jeong, Young Ju; Kwon, Hyo Jung; Park, Young Sun; Kwon, Oh Chang; Shin, Im Hee

    2015-01-01

    Abstract Background: Lymphedema is a troublesome complication affecting quality of life (QoL) in many women after breast-cancer treatment. Recent studies have suggested that acupuncture can reduce symptoms of lymphedema in breast-cancer survivors. Objectives: This was a pilot study. It was designed to assess the feasibility and the safety of acupuncture with the Saam acupuncture method for treating lymphedema in Korean patients after surgical therapy for breast cancer. Materials and Methods: This was a prospective, single-arm, observational pilot study using before and after measurements. The study was conducted at the East-West Medical Center at the Daegu Catholic University Medical Center, in Daegu, Korea. The subjects were 9 patients with breast cancer who presented with lymphedema of the upper limb ipsilateral to surgery. Saam acupuncture was administered 3 times per week for 6 consecutive weeks, for 30±5 minutes at each session.The primary outcome measure was severity of lymphedema as assessed by stages of lymphedema, a visual analogue scale (VAS), and by circumferential measurements of the upper extremity. The secondary outcome measure was QoL, which was assessed by a self-administered questionnaire using the Short Form–36 questionnaire. Results: Acupuncture reduced severity of lymphedema significantly, as assessed by the VAS (P<0.001) as well as by circumferential measurements of the upper extremity. Four weeks after the final treatment, symptoms were not aggravated. SF-36 scores remained significant for health status at the end of treatment. Conclusions: The Saam acupuncture method appeared to provide reduction of lymphedema among women after they had undergone surgery for breast cancer. A randomized, controlled prospective study with a larger sample size is required to clarify the role of acupuncture for managing lymphedema in patients with breast cancer. PMID:26155321

  2. An e-health strategy to facilitate care of breast cancer survivors: A pilot study.

    PubMed

    Tiong, Siaw Sze; Koh, Eng-Siew; Delaney, Geoffrey; Lau, Annie; Adams, Diana; Bell, Vicki; Sapkota, Pharmila; Harris, Therese; Girgis, Afaf; Przezdziecki, Astrid; Lonergan, Denise; Coiera, Enrico

    2016-06-01

    Innovative e-health strategies are emerging, to tailor and provide convenient, systematic and high-quality survivorship care for an expanding cancer survivor population. This pilot study tests the application of an e-health platform, "Healthy.me," in a breast cancer survivor cohort at Liverpool and Macarthur Cancer Therapy Centres, New South Wales, Australia. Fifty breast cancer patients were recruited to use the Healthy.me website, designed by the Centre of Health Informatics at the University of New South Wales, over a 4-month period. Telephone and online questionnaires were used at 1 and 4 months and a face-to-face feedback at study completion, to gather qualitative and quantitative data regarding feasibility of Healthy.me. Healthy.me was reported to be a useful online resource by most users. Usage declined from 76% at 1 month to 48% at 4 months. Breast cancer survivors enjoyed a variety of tailored information regarding health and life-style issues. Positive aspects of Healthy.me were the convenient access to trusted information, and interaction with their peers and healthcare professionals. Barriers to usage contributing to usage decline were lack of reported patient time to re-access information, limited content updates and technical factors. This pilot study suggested the potential of an e-health strategy such as Healthy.me in addressing the needs of a growing breast cancer survivor population. Ongoing development of a more robust e-health resource and integration with primary care models is warranted. © 2016 John Wiley & Sons Australia, Ltd.

  3. A Pilot Study of Expressive Writing Intervention among Chinese Speaking Breast Cancer Survivors

    PubMed Central

    Lu, Qian; Zheng, Dianhan; Young, Lucy; Kagawa-Singer, Marjorie; Loh, Alice

    2013-01-01

    Objective Little attention has been focused on Asian American breast cancer survivor's psychological needs. No outcome based psychosocial interventions have been reported to target at this population. Expressive writing interventions have been previously shown to improve health outcomes among non-Hispanic white breast cancer populations. This pilot study aimed to test the cultural sensitivity, feasibility, and potential health benefits of an expressive writing intervention among Chinese-speaking breast cancer survivors. Methods Participants (N=19) were asked to write about their deepest thoughts and feelings, their coping efforts, and positive thoughts and feelings regarding their experience with breast cancer each week for three weeks. Health outcomes were assessed at baseline, three, and six months after the intervention. A Community-Based Participatory Research Approach (CBPR) is used. Results Expressive writing was associated with medium and large effect sizes (ηp2= 0.066~0.208) in improving multiple health outcomes (quality of life, fatigue, posttraumatic stress, intrusive thoughts, and positive affect) at follow-ups. Participants perceived the study to be valuable. The study yielded high compliance and completion rates. Conclusion Expressive writing is associated with long-term improvement of health outcomes among Chinese breast cancer survivors and has the potential to be utilized as a support strategy for minority cancer survivors. In addition, CBPR is valuable in improving feasibility and cultural sensitivity of the intervention in understudied populations. Future studies employing randomized controlled trial designs are warranted. PMID:22229930

  4. Breast Cancer Education for Navajo Women: a Pilot Study Evaluating a Culturally Relevant Video

    PubMed Central

    Teufel-Shone, Nicolette I.; Baldwin, Julie A.; Sandoval, Nellie; Robinson, Frances

    2010-01-01

    This pilot study evaluated a culturally specific video designed to teach Navajo women about breast cancer treatment options. Fourteen Navajo women diagnosed with breast cancer and 26 healthcare providers participated in a mixed-method evaluation that documented their perceptions immediately and 6 months after viewing the video. After initial viewing, women reported reduced anxiety about treatment and interest in support groups. Six months later, women said the video prompted them to seek more information from printed sources and their provider. Younger Navajo women who were 44 to 51 years old were more likely to attend support groups than women who were 55–67 years. Providers corroborated the positive effects of the video. The providers believed the video encouraged patients to seek information about breast cancer and to ask questions about treatment plans and side effects. A culturally relevant video for Navajo women can be an effective teaching tool and can enhance patient–provider communication. PMID:20111913

  5. Estimating the incidence of malignant mesothelioma in Vietnam: a pilot descriptive cancer registration study

    PubMed Central

    Soeberg, Matthew J.; Luong, Mai Anh; Tran, Van Thuan; Tran, Anh Thanh; Nguyen, Thị Thu Huyen; Bui, Dieu; Nguyen, Thi Hoai Nga; Takahashi, Ken; van Zandwijk, Nico

    2016-01-01

    Introduction Global asbestos consumption has shifted toward lower income countries, particularly in the Asian region including Vietnam where asbestos and asbestos-containing products have been imported since the late 1960s. Methods This pilot descriptive epidemiological study aimed to provide contemporary estimates of malignant mesothelioma incidence (histological subtype M9050/3; ICD-O-3) by gender and age group as recorded across nine cancer registries in Vietnam. Results We identified 148 incident cases of malignant mesothelioma during 1987–2013. The majority of cases were recorded in the Hanoi region (n = 93) and were aged 55 years or older (n = 96). Discussion By carefully reviewing existing cancer registry records in Vietnam, we identified a larger number of malignant mesothelioma cases than previously estimated. We recommend the use of cancer registry data in tracking future asbestos-related disease in Vietnam. PMID:27388204

  6. The photodynamic detection of mucosal abnormality in oral cancer patients: a pilot study

    NASA Astrophysics Data System (ADS)

    O'Dwyer, Martin; Ogden, Graham; McLaren, Stuart; Padgett, Miles

    2005-03-01

    Patients who have had one oral cancer are at increased risk of developing a semi-malignant tumour. The detecting of oral cancer is made difficult (and is often delayed) by the unknown appearance of the early oral lesion. A technique that could reliably detect early cancers would be useful to the oral and dental health specialist. One possible technique is the use of a photosensitiser that may be preferentially taken up by cancerous cells. 5-aminolaevulinic acid (ALA) is one such drug that is converted to Protoporphyrin IX (PpIX) and fluoresces at 636nm when illuminated with light of wavelength 405nm. It has been hypothesized that cell inclined towards malignant change would have a higher metabolic rate, and thus convert more ALA into its metabolite PpIX. These drugs can then be detected using a technique called Photodynamic detection, through the analysis of their fluorescence spectra. We describe a pilot study that used a compact spectroscopic instrument designed to excite and measure fluorescence in the oral cavity. Some Inter-subject variation in PpIX time course characteristics may be evident in our volunteers, as has been reported by other researchers. The obtained data would suggest that this instrument may be a valuable tool for detecting early oral cancers. However, further studies are required, not least to ensure that these data are due to detection of ALA metabolite in cancer and not some other systemic effect.

  7. Lung cancer in uranium miners: A tissue resource and pilot study. Final performance report

    SciTech Connect

    Samet, J.; Gilliland, F.D.

    1998-08-13

    This project incorporates two related research projects directed toward understanding respiratory carcinogenesis in radon-exposed former uranium miners. The first project involved a continuation of the tissue resource of lung cancer cases from former underground uranium miners and comparison cases from non-miners. The second project was a pilot study for a proposed longitudinal study of respiratory carcinogenesis in former uranium miners. The objectives including facilitating the investigation of molecular changes in radon exposed lung cancer cases, developing methods for prospectively studying clinical, cytologic, cytogenetic, and molecular changes in the multi-event process of respiratory carcinogenesis, and assessing the feasibility of recruiting former uranium miners into a longitudinal study that collected multiple biological specimens. A pilot study was conducted to determine whether blood collection, induced sputum, bronchial brushing, washings, and mucosal biopsies from participants at two of the hospitals could be included efficiently. A questionnaire was developed for the extended study and all protocols for specimen collection and tissue handling were completed. Resource utilization is in progress at ITRI and the methods have been developed to study molecular and cellular changes in exfoliated cells contained in sputum as well as susceptibility factors.

  8. Breast cancer and personal environmental risk factors in Marin County - Pilot study

    SciTech Connect

    Erdmann, C.A.; Farren, G.; Baltzell, K.; Chew, T.; Clarkson, C.; Fleshman, R.; Leary, C.; Mizroch, M.; Orenstein, F.; Russell, M.L.; Souders-Mason, V.; Wrensch, M.

    2003-02-01

    The purpose of the Personal Environmental Risk Factor Study (PERFS) pilot project was to develop methodologies and a questionnaire for a future population-based case-control study to investigate the role of selected environmental exposures in breast cancer development. Identification of etiologically relevant exposures during a period of potential vulnerability proximate to disease onset offers the possibility of clinical disease prevention even when disease initiation may have already occurred many years earlier. Certain personal environmental agents or combinations of agents may influence disease promotion. Therefore, this pilot study focused on exposures that occurred during the ten-year period prior to diagnosis for cases and the last ten years for controls, rather than more historic exposures. For this pilot study, they used a community-based research approach. In the collaborative efforts, community members participated with academic researchers in all phases of the research, including research question identification, study design, development of research tools, development of the human subjects protocol, and report writing. Community member inclusion was based upon the concept that community participation could improve the relevance of scientific studies and ultimate success of the research by encouraging an ongoing dialogue between community members and academic representatives. Early activities of this project focused on the collection of input from the community regarding the possible role of environmental factors in the incidence of breast cancer in Marin County. The intent was to inform the scientists of community concerns, enhance the research team's understanding of the community being studied, and provide interested community members with a better understanding of the strengths and weaknesses of traditional research methods through active participation in the research process.

  9. Breast cancer and menopause: partners' perceptions and personal experiences--a pilot study.

    PubMed

    Sayakhot, Padaphet; Vincent, Amanda; Teede, Helena

    2012-08-01

    The aim of this study was to describe the partners' perceptions, understanding, and personal experiences of early menopause and menopausal therapy in women with breast cancer. A questionnaire study was completed by 50 partners of women with diagnoses of breast cancer, recruited via outpatient clinics and the community. Descriptive statistics and χ tests were applied. Most (68%) of the partners perceived hot flushes as the meaning of menopause. Most (60%) partners perceived that loss of sexuality was the key problem/fears about being menopausal. Partners perceived that exercise (72%) and reducing stress (64%) were most effective in alleviating symptoms of menopause. Most partners reported that they did not understand the risks/benefits of hormone therapy (50%), bioidentical hormones (90%), and herbal therapies (84%). The general practitioner was considered the best source of information on menopause (68%). Partners expected menopause to affect a women's everyday life and relationships with family and partner and, particularly, to cause intermittent stress on the relationship (66%) and to decrease libido or sexual interest (64%). Forty-four percent of partners reported that there was some difficulty in communication/discussion about menopause with family and partners. This pilot study highlights (1) the lack of understanding of menopause and menopausal therapies that partners of women with breast cancer have, (2) the personal experience of having a female partner with breast cancer, and (3) the partners' attitudes and responses toward menopause in women with breast cancer.

  10. Cancer sniffer dogs: how can we translate this peculiarity in laboratory medicine? Results of a pilot study on gastrointestinal cancers.

    PubMed

    Panebianco, Concetta; Kelman, Edgar; Vene, Kristel; Gioffreda, Domenica; Tavano, Francesca; Vilu, Raivo; Terracciano, Fulvia; Pata, Illar; Adamberg, Kaarel; Andriulli, Angelo; Pazienza, Valerio

    2017-06-07

    Identification of cancer biomarkers to allow early diagnosis is an urgent need for many types of tumors, whose prognosis strongly depends on the stage of the disease. Canine olfactory testing for detecting cancer is an emerging field of investigation. As an alternative, here we propose to use GC-Olfactometry (GC/O), which enables the speeding up of targeted biomarker identification and analysis. A pilot study was conducted in order to determine odor-active compounds in urine that discriminate patients with gastrointestinal cancers from control samples (healthy people). Headspace solid phase microextraction (HS-SPME)-GC/MS and GC-olfactometry (GC/O) analysis were performed on urine samples obtained from gastrointestinal cancer patients and healthy controls. In total, 91 key odor-active compounds were found in the urine samples. Although no odor-active biomarkers present were found in cancer carrier's urine, significant differences were discovered in the odor activities of 11 compounds in the urine of healthy and diseased people. Seven of above mentioned compounds were identified: thiophene, 2-methoxythiophene, dimethyl disulphide, 3-methyl-2-pentanone, 4-(or 5-)methyl-3-hexanone, 4-ethyl guaiacol and phenylacetic acid. The other four compounds remained unknown. GC/O has a big potential to identify compounds not detectable using untargeted GC/MS approach. This paves the way for further research aimed at improving and validating the performance of this technique so that the identified cancer-associated compounds may be introduced as biomarkers in clinical practice to support early cancer diagnosis.

  11. Restorative yoga for women with ovarian or breast cancer: findings from a pilot study.

    PubMed

    Danhauer, Suzanne C; Tooze, Janet A; Farmer, Deborah F; Campbell, Cassie R; McQuellon, Richard P; Barrett, Rolland; Miller, Brigitte E

    2008-01-01

    Yoga has demonstrated benefit in healthy individuals and those with various health conditions. There are, however, few systematic studies to support the development of yoga interventions for cancer patients. Restorative yoga (RY) is a gentle type of yoga that has been described as "active relaxation." The specific aims of this pilot study were to determine the feasibility of implementing an RY intervention as a supportive therapy for women diagnosed with ovarian or breast cancer and to measure changes in self-reported fatigue, psychological distress and well-being, and quality of life. Fifty-one women with ovarian (n = 37) or breast cancer (n = 14) with a mean age of 58.9 years enrolled in this study; the majority (61%) were actively undergoing cancer treatment at the time of enrollment. All study participants participated in 10 weekly 75-minute RY classes that combined physical postures, breathing, and deep relaxation. Study participants completed questionnaires at baseline, immediately postintervention, and 2 months postintervention. Significant improvements were seen for depression, negative affect, state anxiety, mental health, and overall quality of life. Fatigue decreased between baseline and postintervention follow-up. Health-related quality of life improved between baseline and the 2-month follow-up. Qualitative feedback from participants was predominantly positive; relaxation and shared group experience were two common themes.

  12. Reiki for Cancer Patients Undergoing Chemotherapy in a Brazilian Hospital: A Pilot Study.

    PubMed

    Siegel, Pamela; da Motta, Pedro Mourão Roxo; da Silva, Luis G; Stephan, Celso; Lima, Carmen Silvia Passos; de Barros, Nelson Filice

    2016-01-01

    The purpose of this pilot study was to explore whether individualized Reiki given to cancer patients at a Brazilian hospital improved symptoms and well-being. Data from 36 patients who received 5 Reiki sessions were collected using the MYMOP and were compared before and after their treatment and also with 14 patients who did not receive Reiki and who acted as a comparison group. Twenty-one patients reported feeling better, 12 felt worse, and 3 reported no change. Of the comparison group, 6 patients reported feeling better and 8 felt worse. The Reiki practice delivered as part of the integrative care in oncology did produce clinically significant effects, although not statistically significant results, for more than half of the patients undergoing cancer treatment.

  13. Social support and social control in the context of cancer patients’ exercise: A pilot study

    PubMed Central

    Ungar, Nadine; Wiskemann, Joachim; Weißmann, Mareike; Knoll, Annika; Steindorf, Karen; Sieverding, Monika

    2016-01-01

    Social support is an important factor for exercise among cancer patients, but too much control might elicit reactance and lead to detrimental effects. In this pilot study, 56 dyads (cancer patient + relative) filled out a questionnaire assessing social support, social control, and reactance. After 4 weeks (T2), patients’ exercise was assessed with a 7-day recall. About half of the patients did not engage in any self-reported exercise behavior. Relative-reported support was the only variable associated with exercise behavior at T2. Perceived control (r = .4) but not perceived support was significantly correlated with reactance. Male patients reported more support, but were also more prone to reactance. PMID:28815053

  14. A Pilot and Feasibility Study of Virtual Reality as a Distraction for Children with Cancer

    ERIC Educational Resources Information Center

    Gershon, Jonathan; Zimand, Elana; Pickering, Melissa; Rothbaum, Barbara Olasov; Hodges, Larry

    2004-01-01

    Objective: To pilot and test the feasibility of a novel technology to reduce anxiety and pain associated with an invasive medical procedure in children with cancer. Method: Children with cancer (ages 7-19) whose treatment protocols required access of their subcutaneous venous port device (port access) were randomly assigned to a virtual reality…

  15. A Pilot and Feasibility Study of Virtual Reality as a Distraction for Children with Cancer

    ERIC Educational Resources Information Center

    Gershon, Jonathan; Zimand, Elana; Pickering, Melissa; Rothbaum, Barbara Olasov; Hodges, Larry

    2004-01-01

    Objective: To pilot and test the feasibility of a novel technology to reduce anxiety and pain associated with an invasive medical procedure in children with cancer. Method: Children with cancer (ages 7-19) whose treatment protocols required access of their subcutaneous venous port device (port access) were randomly assigned to a virtual reality…

  16. Yoga for Persistent Fatigue in Breast Cancer Survivors: Results of a Pilot Study

    PubMed Central

    Bower, Julienne E.; Garet, Deborah; Sternlieb, Beth

    2011-01-01

    Approximately one-third of breast cancer survivors experiences persistent fatigue for months or years after successful treatment completion. There is a lack of evidence-based treatments for cancer-related fatigue, particularly among cancer survivors. This single-arm pilot study evaluated the feasibility and preliminary efficacy of a yoga intervention for fatigued breast cancer survivors based on the Iyengar tradition. Iyengar yoga prescribes specific poses for individuals with specific medical problems and conditions; this trial emphasized postures believed to be effective for reducing fatigue among breast cancer survivors, including inversions and backbends performed with the support of props. Twelve women were enrolled in the trial, and 11 completed the full 12-week course of treatment. There was a significant improvement in fatigue scores from pre- to post-intervention that was maintained at the 3-month post-intervention followup. Significant improvements were also observed in measures of physical function, depressed mood, and quality of life. These results support the acceptability of this intervention and suggest that it may have beneficial effects on persistent post-treatment fatigue. However, results require replication in a larger randomized controlled trial. PMID:21274288

  17. Collagen I fiber density increases in lymph node positive breast cancers: pilot study

    NASA Astrophysics Data System (ADS)

    Kakkad, Samata M.; Solaiyappan, Meiyappan; Argani, Pedram; Sukumar, Saraswati; Jacobs, Lisa K.; Leibfritz, Dieter; Bhujwalla, Zaver M.; Glunde, Kristine

    2012-11-01

    Collagen I (Col1) fibers are a major structural component in the extracellular matrix of human breast cancers. In a preliminary pilot study, we explored the link between Col1 fiber density in primary human breast cancers and the occurrence of lymph node metastasis. Col1 fibers were detected by second harmonic generation (SHG) microscopy in primary human breast cancers from patients presenting with lymph node metastasis (LN+) versus those without lymph node metastasis (LN-). Col1 fiber density, which was quantified using our in-house SHG image analysis software, was significantly higher in the primary human breast cancers of LN+ (fiber volume=29.22%±4.72%, inter-fiber distance=2.25±0.45 μm) versus LN- (fiber volume=20.33%±5.56%, inter-fiber distance=2.88±1.07 μm) patients. Texture analysis by evaluating the co-occurrence matrix and the Fourier transform of the Col1 fibers proved to be significantly different for the parameters of co-relation and energy, as well as aspect ratio and eccentricity, for LN+ versus LN- cases. We also demonstrated that tissue fixation and paraffin embedding had negligible effect on SHG Col1 fiber detection and quantification. High Col1 fiber density in primary breast tumors is associated with breast cancer metastasis and may serve as an imaging biomarker of metastasis.

  18. Physical activity and lung cancer among non-smokers: a pilot molecular epidemiological study within EPIC.

    PubMed

    Rundle, Andrew; Richie, John; Steindorf, Karen; Peluso, Marco; Overvad, Kim; Raaschou-Nielsen, Ole; Clavel-Chapelon, Francoise; Linseisen, Jacob P; Boeing, Heiner; Trichopoulou, Antonia; Palli, Domenico; Krogh, Vittorio; Tumino, Rosario; Panico, Salvatore; Bueno-De-Mesquita, Hendrik B; Peeters, Petra H; Lund, Eiliv; Gonzalez, Carlos A; Martinez, Carmen; Dorronsoro, Miren; Barricarte, Aurelio; Tormo, M Jose; Quiros, Josèr; Agudo, Antonio; Berglund, Goran; Jarvholm, Bengt; Bingham, Sheila; Key, Timothy J; Gormally, Emmanuelle; Saracci, Rodolfo; Kaaks, Rudolf; Riboli, Elio; Vineis, Paolo

    2010-02-01

    The association between physical activity, potential intermediate biomarkers and lung cancer risk was investigated in a study of 230 cases and 648 controls nested within the European Prospective Investigation of Cancer and Nutrition. Data on white blood cell aromatic-DNA adducts by (32)P-post-labelling and glutathione (GSH) in red blood cells were available from a subset of cases and controls. Compared with the first quartile, the fourth quartile of recreational physical activity was associated with a lower lung cancer risk (odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.90), higher GSH levels (+1.87 micromol GSH g(-1) haemoglobin, p = 0.04) but not with the presence of high levels of adducts (OR 1.05, 95% CI 0.38-2.86). Despite being associated with recreational physical activity, in these small-scale pilot analyses GSH levels were not associated with lung cancer risk (OR 0.95, 95% CI 0.84-1.07 per unit increase in GSH levels). Household and occupational activity was not associated with lung cancer risk or biomarker levels.

  19. Centering prayer for women receiving chemotherapy for recurrent ovarian cancer: a pilot study.

    PubMed

    Johnson, Mary E; Dose, Ann M; Pipe, Teri Britt; Petersen, Wesley O; Huschka, Mashele; Gallenberg, Mary M; Peethambaram, Prema; Sloan, Jeff; Frost, Marlene H

    2009-07-01

    To explore the feasibility of implementing centering prayer in chemotherapy treatment and assess its influence on mood, spiritual well-being, and quality of life in women with recurrent ovarian cancer. Descriptive pilot study. Outpatient chemotherapy treatment suite in a large cancer center in the midwestern United States. A convenience sample of 10 women receiving outpatient chemotherapy for recurrent ovarian cancer. A centering prayer teacher led participants through three one-hour sessions over nine weeks. Data were collected prior to the first session, at the conclusion of the final session, and at three and six months after the final session. Feasibility and influence of centering prayer on mood, spiritual well-being, and quality of life. Most participants identified centering prayer as beneficial. Emotional well-being, anxiety, depression, and faith scores showed improvement. Centering prayer can potentially benefit women with recurrent ovarian cancer. Additional research is needed to assess its feasibility and effectiveness. Nurses may promote or suggest centering prayer as a feasible intervention for the psychological and spiritual adjustment of patients with recurrent ovarian cancer.

  20. Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes.

    PubMed

    Coronado, Gloria D; Vollmer, William M; Petrik, Amanda; Aguirre, Josue; Kapka, Tanya; Devoe, Jennifer; Puro, Jon; Miers, Tran; Lembach, Jennifer; Turner, Ann; Sanchez, Jennifer; Retecki, Sally; Nelson, Christine; Green, Beverly

    2014-02-26

    Colorectal-cancer is a leading cause of cancer death in the United States, and Latinos have particularly low rates of screening. Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) is a partnership among two research institutions and a network of safety net clinics to promote colorectal cancer screening among populations served by these clinics. This paper reports on results of a pilot study conducted in a safety net organization that serves primarily Latinos. The study assessed two clinic-based approaches to raise rates of colorectal-cancer screening among selected age-eligible patients not up-to-date with colorectal-cancer screening guidelines. One clinic each was assigned to: (1) an automated data-driven Electronic Health Record (EHR)-embedded program for mailing Fecal Immunochemical Test (FIT) kits (Auto Intervention); or (2) a higher-intensity program consisting of a mailed FIT kit plus linguistically and culturally tailored interventions delivered at the clinic level (Auto Plus Intervention). A third clinic within the safety-net organization was selected to serve as a passive control (Usual Care). Two simple measurements of feasibility were: 1) ability to use real-time EHR data to identify patients eligible for each intervention step, and 2) ability to offer affordable testing and follow-up care for uninsured patients. The study was successful at both measurements of feasibility. A total of 112 patients in the Auto clinic and 101 in the Auto Plus clinic met study inclusion criteria and were mailed an introductory letter. Reach was high for the mailed component (92.5% of kits were successfully mailed), and moderate for the telephone component (53% of calls were successful completed). After exclusions for invalid address and other factors, 206 (109 in the Auto clinic and 97 in the Auto Plus clinic) were mailed a FIT kit. At 6 months, fecal test completion rates were higher in the Auto (39.3%) and Auto Plus (36.6%) clinics

  1. Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes

    PubMed Central

    2014-01-01

    Background Colorectal-cancer is a leading cause of cancer death in the United States, and Latinos have particularly low rates of screening. Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) is a partnership among two research institutions and a network of safety net clinics to promote colorectal cancer screening among populations served by these clinics. This paper reports on results of a pilot study conducted in a safety net organization that serves primarily Latinos. Methods The study assessed two clinic-based approaches to raise rates of colorectal-cancer screening among selected age-eligible patients not up-to-date with colorectal-cancer screening guidelines. One clinic each was assigned to: (1) an automated data-driven Electronic Health Record (EHR)-embedded program for mailing Fecal Immunochemical Test (FIT) kits (Auto Intervention); or (2) a higher-intensity program consisting of a mailed FIT kit plus linguistically and culturally tailored interventions delivered at the clinic level (Auto Plus Intervention). A third clinic within the safety-net organization was selected to serve as a passive control (Usual Care). Two simple measurements of feasibility were: 1) ability to use real-time EHR data to identify patients eligible for each intervention step, and 2) ability to offer affordable testing and follow-up care for uninsured patients. Results The study was successful at both measurements of feasibility. A total of 112 patients in the Auto clinic and 101 in the Auto Plus clinic met study inclusion criteria and were mailed an introductory letter. Reach was high for the mailed component (92.5% of kits were successfully mailed), and moderate for the telephone component (53% of calls were successful completed). After exclusions for invalid address and other factors, 206 (109 in the Auto clinic and 97 in the Auto Plus clinic) were mailed a FIT kit. At 6 months, fecal test completion rates were higher in the Auto (39.3%) and Auto

  2. Mutans streptococci in xerostomic cancer patients after pilocarpine therapy: a pilot study.

    PubMed

    Chambers, Mark S; Keene, Harris J; Toth, Béla B; Lemon, James C; Gallagher, Susan C; Martin, Charles G; Martin, Jack W

    2005-02-01

    Opiod- and/or radiation-induced xerostomia in cancer patients is frequently associated with elevated levels of cariogenic mutans streptococci (MS). In a single-center, single blind 8-week clinical trial at The University of Texas M. D. Anderson Cancer Center, and from an initial sample of 32 patients, we evaluated MS counts in 28 cancer patients receiving chronic analgesic treatment for cancer pain. All patients received escalating doses of pilocarpine (Salagen) tablets, either 2.5 mg to 5 mg or 5 mg to 7.5 mg qid for 6 weeks, followed by placebo qid for a 2-week washout period. Whole resting saliva flow rates (g/5 min) and MS counts were evaluated at pretreatment, 3 weeks, 6 weeks, and 8 weeks. MS samples were obtained by 5-mL saline rinse (15 sec) at each visit prior to sialometry. In 19 patients (59%), MS counts exceeded 10(5) CFU/mL. At the end of the 6-week trial, 96% of patients showed a positive response to pilocarpine following a 30-minute postdosing evaluation (P=.001). MS counts were lower in 17 patients, higher in 6 patients, and nondetectable before and after pilocarpine in 5 patients (P=.03). The reduced MS counts associated with improved saliva flow rates following pilocarpine therapy in this short-term pilot study are encouraging, but further investigation in a larger group of patients over a longer study period is indicated.

  3. Artificial neural networks in the diagnosis and prognosis of prostate cancer: a pilot study.

    PubMed

    Snow, P B; Smith, D S; Catalona, W J

    1994-11-01

    There is controversy about how prostate cancer screening tests should best be used because of the false-negative and false-positive results. There also is controversy about prostate cancer treatment because of errors in tumor staging, uncertainty about treatment efficacy and the variable natural history of the disease. We sought to determine in a pilot study whether artificial neural networks would be helpful to predict biopsy results in men with abnormal screening test(s) and to predict treatment outcome after radical prostatectomy. To predict biopsy results, we extracted data from a prostate specific antigen (PSA) based screening study data base in 1,787 men with a serum PSA concentration of more than 4.0 ng./ml. (approximately 40% of the men also had suspicious findings on digital rectal examination). To predict cancer recurrence after radical prostatectomy, we extracted data from a random sample of 240 patients selected from a data base of men who had undergone radical prostatectomy. The neural network predicted the biopsy result with 87% overall accuracy, and its output threshold could be adjusted to achieve the desired tradeoff between sensitivity and specificity. It also predicted tumor recurrence with 90% overall accuracy. We conclude that trained neural networks may be useful in decision making for prostate cancer patients.

  4. Proteomic analysis of field cancerization in pharynx and oesophagus: a prospective pilot study.

    PubMed

    Roesch-Ely, Mariana; Leipold, Alexandra; Nees, Matthias; Holzinger, Dana; Dietz, Andreas; Flechtenmacher, Christa; Wolf, Thomas; Zapatka, Marc; Bosch, Franz X

    2010-08-01

    'Field cancerization' in head and neck squamous cell carcinoma (HNSCC) is poorly understood and it may extend from the pharynx into the oesophagus. Both local recurrences and second primary carcinomas/second field tumours may originate from field cancerization. Our prospective pilot study aimed at the identification of patients suffering from field cancerization on the basis of mucosal protein profiles. Five mucosal biopsies from the oropharynx, hypopharynx and from three regions of the oesophagus were taken from 24 patients. Protein profiles were generated from the mucosal biopsies. After classifier learning, using the profiles of the patients without tumour diagnosis (n = 9), we were able to discriminate between the different mucosal sites and between healthy mucosa and HNSCC using tumour and healthy tissue samples. Mucosal biopsies of tumour patients (n = 15) revealed changes in the protein profiles similar to those in the tumours. During 42 months median follow-up, six tumour patients experienced local recurrences and second field tumours, of which three occurred in the oesophagus. In all six cases, tumour relapse was correctly predicted by altered mucosal protein profiles (p = 0.007, Fisher's exact test, two-tailed). Consequently, molecular field cancerization had a strong impact on progression-free survival (p = 0.007, log-rank test). Protein profiles of small diagnostic biopsies hold great promise to improve personalized risk assessment in HNSCC. Larger studies are needed to further substantiate these findings.

  5. A pilot case-cohort study of liver and pancreatic cancers in poultry workers.

    PubMed

    Felini, Martha; Johnson, Eric; Preacely, Nykiconia; Sarda, Vishnu; Ndetan, Harrison; Bangara, Saritha

    2011-10-01

    To test the hypothesis that exposure to poultry oncogenic viruses that widely occurs occupationally in poultry workers and in the general population, may be associated with increased risks of deaths from liver and pancreatic cancers, and to identify new risk factors. A pilot case-cohort study of both cancers within a combined cohort of 30,411 highly exposed poultry workers and 16,408 control subjects was conducted, and risk assessed by logistic regression odds ratios (OR) and proportional hazards risk ratios. New occupational findings were recorded respectively for pancreatic/liver cancers, for slaughtering of poultry (OR = 8.9, 95% confidence interval [CI]: 2.7-29.3)/OR = 9.1, 95% CI: 1.9-42.9); catching of live chickens (OR = 3.6, 95% CI: 1.2-10.9)/OR = 1.0, 95% CI: 0.1-8.5); killing other types of animals for food (OR = 4.8, 95% CI: 1.5-16.6)/OR = 2.0, 95% CI: 0.2-18.2), and ever worked on a pig raising farm (OR = 3.0, 95% CI: 1.0-8.2) for pancreatic cancer only. New non-occupational findings for liver cancer were for receiving immunization with yellow fever vaccine (OR = 8.7, 95% CI: 1.0-76.3); and vaccination with typhoid vaccine (OR = 6.3, 95% CI: 1.1-37.4). The study also confirmed previously reported risk factors for both diseases. This study provides preliminary evidence that exposure to poultry oncogenic viruses may possibly be associated with the occurrence of liver and pancreatic cancers. Case-control studies nested within occupational cohorts of highly exposed subjects of sufficient statistical power may provide an efficient and valid method of investigating/confirming these findings. Copyright © 2011 Elsevier Inc. All rights reserved.

  6. Improved sleep after Qigong exercise in breast cancer survivors: A pilot study

    PubMed Central

    Liu, Wen; Schaffer, Lauren; Herrs, Natalie; Chollet, Christine; Taylor, Sarah

    2015-01-01

    Objective: Sleep disorder and fatigue are among a few major concerns of breast cancer survivors across the survivorship trajectory. The purpose of this pilot study was to examine feasibility and trends in multiple outcomes after a 6-week Qigong exercise program in breast cancer survivors. Methods: Eight female adults (mean age 55.4 ± 9.4 years, mean time after the completion of cancer treatment 3.9 ± 5.7 years) who had a diagnosis of breast cancer and were at least 3 months postcompletion of primary cancer treatment prior to participation in this study. Baseline evaluation was administered using subjective questionnaires on sleep quality, insomnia, fatigue, and quality of life. All subjects participated in two training sessions to learn the “Six Healing Sound” Qigong exercise and attended group Qigong sessions once per week in the following 6 weeks. In addition to the group sessions, subjects were asked to perform the Qigong exercises twice at home right before going to bed in the evening and immediately after getting up in the morning. Following the 6-week intervention, subjects were re-assessed using the same questionnaires. Pre- and post-intervention scores were analyzed for statistical significance. Results: Compliance rate was 89.6% for group sessions and 78.5% (ranging from 65.6% to 90.7%) for daily home Qigong exercises. No participant reported any adverse event or side effect during the study. All participants indicated in the end-intervention questionnaire that they would highly recommend the intervention to others. Significant improvements were observed in sleeping quality score (from 10.3 ± 3.6 to 5.4 ± 2.3, P < 0.01), insomnia index score (from 16.2 ± 3.2 to 6.8 ± 4.8, P < 0.01), fatigue score (from 60.3 ± 9.4 to 49.1 ± 8.6, P < 0.01), and SF-36 score (from 66.8 ± 7.7 to 80.9 ± 3.9, P < 0.01). Conclusions: Results of this single arm pilot study showed the feasibility and potential of “Six Healing Sounds” Qigong exercise for improving

  7. Paullinia cupana for control of hot flashes in breast cancer patients: a pilot study

    PubMed Central

    Oliveira, Saulo Silva; del Giglio, Adriana Braz; Lerner, Tatiana Goberstein; Zanellato, Rebecca Melo; Tiemi, Livia; Reifur, Lucas; Santi, Patrícia Xavier; del Giglio, Auro

    2013-01-01

    ABSTRACT Objective: To evaluated whether Paullinia cupana decrease number and severity of hot flashes in breast cancer survivors. Methods: This was a prospective phase II pilot study. We studied female breast cancer survivors who had completed the cancer treatment 3 months previously and who were experiencing at least 14 hot flashes per week. At least 9 of the 15 patients were required to have a decrease of at least 50% in hot flash severity score in keeping with the Simon Design. Patients received 50mg of dry extract of Paullinia cupana orally twice a day for 6 weeks. We assessed both frequency and severity of hot flashes. Results: A total of 18 patients started the Paullinia cupana treatment, and 15 completed the study. Three patients left the study immediately after starting the treatment because of personal difficulties in participation or noncompliance. Of the 15 patients who completed the study 10 had a decrease of more than 50% in hot flash severity scores. During the 6 weeks of treatment, statistically significant decreases were seen in both numbers of hot flashes (p=0.0009) and severity scores (p<0.0001). Paullinia cupana was well tolerated, and there were no instances of discontinuation because of toxicity. Conclusions: Paullinia cupana appears promising for controlling hot flashes. More extensive studies seem warranted. PMID:24488380

  8. Paullinia cupana for control of hot flashes in breast cancer patients: a pilot study.

    PubMed

    Oliveira, Saulo Silva; Del Giglio, Adriana Braz; Lerner, Tatiana Goberstein; Zanellato, Rebecca Melo; Tiemi, Livia; Reifur, Lucas; Santi, Patrícia Xavier; Del Giglio, Auro

    2013-12-01

    To evaluated whether Paullinia cupana decrease number and severity of hot flashes in breast cancer survivors. This was a prospective phase II pilot study. We studied female breast cancer survivors who had completed the cancer treatment 3 months previously and who were experiencing at least 14 hot flashes per week. At least 9 of the 15 patients were required to have a decrease of at least 50% in hot flash severity score in keeping with the Simon Design. Patients received 50mg of dry extract of Paullinia cupana orally twice a day for 6 weeks. We assessed both frequency and severity of hot flashes. A total of 18 patients started the Paullinia cupana treatment, and 15 completed the study. Three patients left the study immediately after starting the treatment because of personal difficulties in participation or noncompliance. Of the 15 patients who completed the study 10 had a decrease of more than 50% in hot flash severity scores. During the 6 weeks of treatment, statistically significant decreases were seen in both numbers of hot flashes (p=0.0009) and severity scores (p<0.0001). Paullinia cupana was well tolerated, and there were no instances of discontinuation because of toxicity. Paullinia cupana appears promising for controlling hot flashes. More extensive studies seem warranted.

  9. Hyperspectral imaging fluorescence excitation scanning for detecting colorectal cancer: pilot study

    NASA Astrophysics Data System (ADS)

    Leavesley, Silas J.; Wheeler, Mikayla; Lopez, Carmen; Baker, Thomas; Favreau, Peter F.; Rich, Thomas C.; Rider, Paul F.; Boudreaux, Carole W.

    2016-03-01

    Optical spectroscopy and hyperspectral imaging have shown the theoretical potential to discriminate between cancerous and non-cancerous tissue with high sensitivity and specificity. To date, these techniques have not been able to be effectively translated to endoscope platforms. Hyperspectral imaging of the fluorescence excitation spectrum represents a new technology that may be well-suited for endoscopic implementation. However, the feasibility of detecting differences between normal and cancerous mucosa using fluorescence excitation-scanning hyperspectral imaging has not been evaluated. The objective of this pilot study was to evaluate the changes in the fluorescence excitation spectrum of resected specimen pairs of colorectal adenocarcinoma and normal colorectal mucosa. Patients being treated for colorectal adenocarcinoma were enrolled. Representative adenocarcinoma and normal colonic mucosa specimens were collected from each case. Specimens were flash frozen in liquid nitrogen. Adenocarcinoma was confirmed by histologic evaluation of H&E permanent sections. Hyperspectral image data of the fluorescence excitation of adenocarcinoma and surrounding normal tissue were acquired using a custom microscope configuration previously developed in our lab. Results demonstrated consistent spectral differences between normal and cancerous tissues over the fluorescence excitation spectral range of 390-450 nm. We conclude that fluorescence excitation-scanning hyperspectral imaging may offer an alternative approach for differentiating adenocarcinoma and surrounding normal mucosa of the colon. Future work will focus on expanding the number of specimen pairs analyzed and will utilize fresh tissues where possible, as flash freezing and reconstituting tissues may have altered the autofluorescence properties.

  10. Copper isotope effect in serum of cancer patients. A pilot study.

    PubMed

    Télouk, Philippe; Puisieux, Alain; Fujii, Toshiyuki; Balter, Vincent; Bondanese, Victor P; Morel, Anne-Pierre; Clapisson, Gilles; Lamboux, Aline; Albarede, Francis

    2015-02-01

    The isotope effect describes mass-dependent variations of natural isotope abundances for a particular element. In this pilot study, we measured the (65)Cu/(63)Cu ratios in the serums of 20 breast and 8 colorectal cancer patients, which correspond to, respectively, 90 and 49 samples taken at different times with molecular biomarker documentation. Copper isotope compositions were determined by multiple-collector inductively coupled plasma mass spectrometry (MC-ICP-MS). When compared with the literature data from a control group of 50 healthy blood donors, abundances of Cu isotopes predict mortality in the colorectal cancer group with a probability p = 0.018. For the breast cancer patients and the group of control women the probability goes down to p = 0.0006 and the AUC under the ROC curve is 0.75. Most patients considered in this preliminary study and with serum δ(65)Cu lower than the threshold value of -0.35‰ (per mil) did not survive. As a marker, a drop in δ(65)Cu precedes molecular biomarkers by several months. The observed decrease of δ(65)Cu in the serum of cancer patients is assigned to the extensive oxidative chelation of copper by cytosolic lactate. The potential of Cu isotope variability as a new diagnostic tool for breast and colorectal cancer seems strong. Shifts in Cu isotope compositions fingerprint cytosolic Cu chelation by lactate mono- and bidentates. This simple scheme provides a straightforward explanation for isotopically light Cu in the serum and isotopically heavy Cu in cancer cells: Cu(+) escaping chelation by lactate and excreted into the blood stream is isotopically light. Low δ(65)Cu values in serum therefore reveal the strength of lactate production by the Warburg effect.

  11. Banking on Fatherhood: Pilot Studies of a Computerized Educational Tool on Sperm Banking before Cancer Treatment

    PubMed Central

    Huyghe, Eric; Martinetti, Paul; Sui, Dawen; Schover, Leslie R.

    2011-01-01

    OBJECTIVES We conducted pilot studies of the feasibility and efficacy of an interactive, computerized educational tool, Banking on Fatherhood (BOF METHODS Two small randomized trials were conducted, with 20 male cancer patients eligible to bank sperm in Study 1 and 19 oncology fellows or residents in Study 2. In each trial, half of subjects viewed BOF before completing questionnaires, and half viewed it afterwards. Outcome measures included a knowledge test in both trials and a decisional conflict scale in the patient trial. All participants, plus a panel of ten experts, ultimately viewed BOF and completed a form evaluating its usability and value. RESULTS Patients who completed questionnaires after viewing BOF had significantly less decisional conflict about banking sperm than those who had not viewed it(P = 0.0065), but knowledge scores were not significantly different between groups. Physicians who filled out questionnaires after viewing BOF scored significantly higher on the Knowledge Test (P < 0.006). Patients, physicians and experts rated BOF as easy to use, informative, and addressing important psychosocial concerns, with videos and animations adding to the value of the educational tool. CONCLUSION Pilot studies suggest that BOF is a feasible intervention that could enhance decisions about sperm banking. Research with larger groups is needed to validate its effectiveness. PMID:19061198

  12. Exercise intervention in breast cancer patients with aromatase inhibitor-associated arthralgia: a pilot study.

    PubMed

    DeNysschen, C A; Burton, H; Ademuyiwa, F; Levine, E; Tetewsky, S; O'Connor, T

    2014-07-01

    Aromatase inhibitors (AIs) block estrogen synthesis and are commonly used as adjuvant treatments for breast cancer patients. A common side effect is joint pain. This was a pilot study to examine implementation of an exercise program in reducing joint pain and improving quality of life (QoL) and functional performance in breast cancer patients treated with AIs. Twenty-six participants completed an 8-week, home-based program that combined upper and lower body resistance exercises with self-selected aerobic exercises. We measured: (1) anthropometry (2) functional performance (grip strength, biceps curl to exhaustion, and sit-to-stand and cardiovascular endurance (3-min step test). Joint pain and QoL were assessed using self-administered surveys. Participants reported a significantly lower number of painful joints, an improvement in QoL and a reduction in depressive symptoms. Significant improvements in grip strength, biceps curl, and sit-to-stand (by 14%, 51% and 15% respectively) were also observed. However, we found no significant changes in cardiovascular endurance or in anthropometric measures. An 8-week, home-based exercise program may provide potential benefit to the breast cancer patients undergoing AI treatment by reducing joint pain, improving functional performance and QoL, and reducing depressive symptoms. Further studies are needed to confirm these results.

  13. Pain Intensity and Pain Interference in patients with lung cancer: A pilot study of Biopsychosocial Predictors

    PubMed Central

    Dalton, Jo Ann; Higgins, Melinda K.; Miller, Andrew H.; Keefe, Francis J.; Khuri, Fadlo R.

    2013-01-01

    Objective To explore biopsychosocial factors (beliefs, depression, catastrophizing cytokines) in individuals newly diagnosed with lung cancer and no pain in order to determine their relationship at diagnosis and across time and to determine whether these factors contribute to pain intensity or pain interference with function at pain onset. Methods A longitudinal, exploratory, pilot study was implemented in a private medical center and a VA medical center in the southeast. Twelve subjects not experiencing pain related to cancer of the lung or its treatment were recruited. A Karnofsky status of 40% and Hemoglobin of 8 grams were required. Five questionnaires were completed and 10 cc of blood was drawn at Baseline; 4 questionnaires and blood draws were repeated monthly for 5 months. One Baseline questionnaire and a pain assessment were added at Final. Demographic, clinical and questionnaire data were summarized; standardized scale scores were calculated. Results Biopsychosocial scores that were low at Baseline increased from T1-T4 but decreased slightly T5-T6. Individuals with higher pain intensity and higher pain interference at Final had higher psychosocial scores at Baseline than individuals with lower pain intensity and lower pain interference at Final. Conclusions Unrelated to disease stage, metastasis or treatment, unique, levels of biopsychosocial factors are observed in patients newly diagnosed with lung cancer who report higher levels of Pain Intensity and higher levels of Pain Interference at the time pain occurs. Replication studies are needed to validate this response pattern and determine the value of repeated individual assessments. PMID:24064756

  14. A pilot study on the impact of known drug-drug interactions in cancer patients.

    PubMed

    Ussai, Silvia; Petelin, Riccardo; Giordano, Antonio; Malinconico, Mario; Cirillo, Donatella; Pentimalli, Francesca

    2015-08-25

    When a patient concomitantly uses two or more drugs, a drug-drug interaction (DDI) can possibly occur, potentially leading to an increased or decreased clinical effect of a given treatment. Cancer patients are at high risk of such interactions because they commonly receive multiple medications. Moreover, most cancer patients are elderly and require additional medications for comorbidities. Aim of this preliminary observational study was to evaluate the incidence of well known and established DDIs in a cohort of cancer outpatients undergoing multiple treatments. Anamnestic and clinical data were collected for 64 adult patients in the ambulatory setting with malignant solid tumors who were receiving systemic anticancer treatment. Patients also declared all drugs prescribed by other specialists or self-taken in the previous 2 weeks. DDIs were divided into two different groups: 'neoplastic DDIs' (NDDIs), involving antitumoral drugs, and 'not neoplastic DDIs' (nDDIs), involving all other classes of drugs. The severity of DDIs was classified as major, moderate and minor, according to the 'Institute for Pharmacological Research Mario Negri' definition. About 34 % of cancer outpatients within our cohort were prescribed/assumed interacting drug combinations. The most frequent major NDDIs involved the anticoagulant warfarin (33 % of total NDDIs) that, in association with tamoxifen, or capecitabine and paclitaxel, increased the risk of haemorrhage. About 60 % of nDDIs involved acetylsalicylic acid. Overall, 16 % of DDIs were related to an A-level strength of recommendation to be avoided. The lack of effective communication among specialists and patients might have a role in determining therapeutic errors. Our pilot study, although limited by a small cohort size, highlights the urgent need of implementing the clinical management of cancer outpatients with new strategies to prevent or minimize potential harmful DDIs.

  15. The meaning of life intervention for patients with advanced-stage cancer: development and pilot study.

    PubMed

    Mok, Esther; Lau, Ka-po; Lai, Theresa; Ching, Shirley

    2012-11-01

    To develop the Meaning of Life Intervention in response to the need for brief and meaning-focused interventions in palliative care and to establish potential effect sizes for future full-scale randomized, controlled trials. A randomized, controlled trial conducted to pilot test the Meaning of Life Intervention. A 68-bed oncology inpatient ward in an urban acute general hospital in Hong Kong. 84 patients with advanced-stage cancer. Fifty-eight completed the study. Assessments of outcome variables were conducted at baseline and one day and two weeks after the intervention. Patients were randomly allocated to the intervention group or the control group. Repeated measures analysis of covariance were conducted to assess the impact of the Meaning of Life Intervention on participants' quality of life. The primary outcome was quality of life and was measured by the Quality-of-Life Concerns in the End-of-Life (QOLC-E) questionnaire and with a single-item scale on global quality of life. The eight subscales of the QOLC-E served as secondary outcomes. Statistically significant main effects were noted for the group in the QOLC-E questionnaire total score, the single-item scale on global quality of life, and the existential distress subscale of the QOLC-E questionnaire. The effects represented a medium effect size. The results of this pilot study show that the Meaning of Life Intervention can improve quality of life, particularly existential distress. The Meaning of Life Intervention represents a potentially effective and efficient intervention that is feasible for implementation by nursing staff for patients with advanced-stage cancer in a palliative care setting.

  16. A pilot study of urinary microRNA as a biomarker for urothelial cancer

    PubMed Central

    Snowdon, Jaime; Boag, Sandy; Feilotter, Harriet; Izard, Jason; Siemens, D. Robert

    2013-01-01

    Objective: MicroRNAs (miRNAs) are part of a class of small ribonucleic acid (RNAs). They are important regulatory molecules, involved in several cell processes, such as developmental timing, stem cell division and apoptosis. Dysregulated miRNAs have been identified in several human malignancies, including bladder cancer tissue samples, and may confer a “tumour signature” that can be exploited for diagnostic purposes. We report on a prospective pilot study investigating the diagnostic capability of miRNAs in the urine of patients with urothelial cancer. Methods: Voided urine samples were collected from patients with urothelial carcinoma just prior to bladder tumour resection, as well as age-matched healthy control patients. Pathology demonstrated both low- and high-grade cancer. Total RNA was isolated and quantitative reverse transcriptase-polymerase chain reaction was performed on the RNA extracts using primers for 4 miRNAs shown previously to be dysregulated in solid urothelial carcinomas with RNU6B as the endogenous control. Standard urine cytology was performed on all samples in a blinded fashion. Results: Two miRNAs of interest were dysregulated in the urine from cancer patients with miR-125b showing an average 10.42-fold decrease (p < 0.01) and miR-126 showing an average 2.70-fold increase (p = 0.30) in the cancer samples compared to the normal controls. The sensitivity and specificity of the cytology on the same urine samples were 50% and 80%, respectively. Using these 2 miRNAs only, a decision-tree prediction model was generated for a validation cohort of patients yielding a specificity of 100% and a sensitivity of 80%. Discussion: This preliminary study of candidate urinary miRNA in patients with low- and high-grade urothelial cancer demonstrated a significantly improved diagnostic accuracy over cytology. These results provide rationale for further studies on discovery and validation of candidate miRNAs in voided urine and may potentially lead to the

  17. Qat use and esophageal cancer in Ethiopia: A pilot case-control study

    PubMed Central

    Assefa, Mathewos; Kassa, Endale; Bane, Abate; Gemechu, Tufa; Tilahun, Yared; Endalafer, Nigatu; Ferro, Gilles; Straif, Kurt; Ward, Elizabeth; Aseffa, Abraham; Schüz, Joachim; Jemal, Ahmedin

    2017-01-01

    Background Qat (Catha edulis) chewing is reported to induce lesions in the buccal mucosa, irritation of the esophagus, and esophageal reflux. Case series suggest a possible etiological role in oral and esophageal cancers. This pilot study aimed to generate preliminary estimates of the magnitude and direction of the association between qat use and esophageal cancer (EC) risk and to inform the logistics required to conduct a multi-center case–control study. Methods Between May 2012 and May 2013, 73 EC cases (including 12 gastro-esophageal junction cases) and 133 controls matched individually on sex, age, and residence were enrolled at two endoscopy clinics and a cancer treatment hospital in Addis Ababa. A face-to-face structured questionnaire was administered. Qat use was defined as ever having chewed qat once a week or more frequently for at least one year. Odds ratios were calculated using conditional logistic regression. Results Only 8% of cases resided in Addis Ababa. Qat use was more frequent in cases (36%) than in controls (26%). A 2-fold elevation in EC risk was observed in ever qat chewers compared with never users in unadjusted conditional logistic regression (OR = 2.12; 95% CI = 0.94, 4.74), an association that disappeared after adjusting for differences in tobacco use, consumption of alcohol and green vegetables, education level, and religion (OR = 0.95; 0.22, 4.22). Among never tobacco users, however, a non-significant increase in EC risk was suggested in ever qat users also after adjustment. Increases in EC risk were observed with ever tobacco use, alcohol consumption, low consumption of green vegetables, a salty diet, illiteracy, and among Muslims; the four latter associations were significant. Conclusions This pilot study generated EC risk estimates in association with a habit practiced by millions of people and never before studied in a case–control design. Results must be interpreted cautiously in light of possible selection bias, with some

  18. Urinary Polyamines: A Pilot Study on Their Roles as Prostate Cancer Detection Biomarkers.

    PubMed

    Tsoi, Tik-Hung; Chan, Chi-Fai; Chan, Wai-Lun; Chiu, Ka-Fung; Wong, Wing-Tak; Ng, Chi-Fai; Wong, Ka-Leung

    2016-01-01

    Current screening methods towards prostate cancer (PCa) are not without limitations. Research work has been on-going to assess if there are other better tests suitable for primary or secondary screening of PCa to supplement the serum prostate specific antigen (PSA) test, which fails to work accurately in a grey zone of 4-10ng/ml. In this pilot study, the potential roles of urinary polyamines as prostate cancer biomarkers were evaluated. PCa, benign prostatic hyperplasia (BPH) patients and healthy controls (HC) showing PSA>4.0ng/ml were enrolled in the study. Their urine samples were obtained, and the urinary levels of putrescine (Put), spermidine (Spd) and spermine (Spm) were determined by ultra-high performance liquid chromatography coupled with triple quadrupole mass spectrometer (UPLC-MS/MS). Receiver operating characteristics (ROC) curve and Student's t-test were used to evaluate their diagnostic accuracies. Among the three biogenic polyamines, Spm had demonstrated a good diagnostic performance when comparing their levels in PCa patients with BPH patients (1.47 in PCa vs 5.87 in BPH; p<0.0001). Results are in accordance with transrectal ultrasound prostatic biopsy (TRUSPB) results, with an area under curve (AUC) value of 0.83±0.03. Therefore urinary Spm shows potential to serve as a novel PCa diagnostic biomarker, which in turn can help to address the limited sensitivity and specificity problem of serum PSA test.

  19. A pilot phase II study of capecitabine in advanced or recurrent breast cancer.

    PubMed

    Saeki, Toshiaki; Kimura, Tsunehito; Toi, Masakazu; Taguchi, Tetsuo

    2006-01-01

    A pilot phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent regimen of capecitabine (Xeloda) in patients with advanced or recurrent breast cancer. A total of 23 patients who had received no more than one prior chemotherapy regimen received oral 828 mg/m2 capecitabine twice daily for 3 weeks followed by a 1-week rest period. The response to capecitabine was evaluated in 22 patients (one patient ineligible). The overall response rate was 45.5% (95% CI, 24.4-67.8%), including 1 complete response (4.5%) and 9 patients with partial response (40.9%). A further 7 patients (31.8%) had stable disease. The median duration of response was 7.2 months (range, 3.0-15.8 months) and the median time to progression was 6.4 months (95% CI, 4.1-15.1 months). Treatment-related adverse events >or= grade 3 were observed in 7 patients (30.1%). Intermittent capecitabine therapy (828 mg/m(2) twice daily for 3 weeks followed by a 1-week rest period) was shown to be effective and well tolerated as second-line treatment for advanced or recurrent breast cancer. The Japanese regimen is worthy of further study in larger numbers of patients in phase II / III clinical trials.

  20. Pilot study of a self-administered stress management and exercise intervention during chemotherapy for cancer.

    PubMed

    Wilson, Rick W; Taliaferro, Lindsay A; Jacobsen, Paul B

    2006-09-01

    This pilot project explored the feasibility, safety, and effectiveness of a self-administered exercise and stress management intervention for cancer patients receiving chemotherapy. Thirty-nine of 56 eligible patients (acceptance =69%) with a variety of solid tumors volunteered for the study. Participants were advised to exercise 20-40 min at 50-75% estimated heart rate reserve 3-5 times per week. In addition, patients were provided with instruction and written materials regarding stress management techniques. Follow-up data were collected during regularly scheduled outpatient visits at the start of the second, third, and fourth chemotherapy cycles using diary entries and the same questionnaires previously administered at baseline. Twenty-four of 39 patients (62%) completed all study requirements. These participants completed 438 of the 678 exercise sessions assigned (adherence =62%). Of the stress management techniques, positive thinking most practiced most frequently (48%), followed by deep breathing (38%) and active relaxation (37%). Paired t tests, comparing baseline values with final recorded values, indicated a significant improvement over time in bodily pain (p<0.03) and mental health (p<0.04) subscale scores. Participants' evaluations of the combined intervention were favorable: 90% felt it was helpful to them and 100% would recommend it to another patient. A self-administered intervention combining aerobic exercise and stress management was acceptable and safe for cancer patients receiving chemotherapy. Preliminary data demonstrating intervention efficacy should be confirmed in subsequent randomized clinical trials.

  1. Urinary Polyamines: A Pilot Study on Their Roles as Prostate Cancer Detection Biomarkers

    PubMed Central

    Tsoi, Tik-Hung; Chan, Chi-Fai; Chan, Wai-Lun; Chiu, Ka-Fung; Wong, Wing-Tak; Ng, Chi-Fai; Wong, Ka-Leung

    2016-01-01

    Current screening methods towards prostate cancer (PCa) are not without limitations. Research work has been on-going to assess if there are other better tests suitable for primary or secondary screening of PCa to supplement the serum prostate specific antigen (PSA) test, which fails to work accurately in a grey zone of 4-10ng/ml. In this pilot study, the potential roles of urinary polyamines as prostate cancer biomarkers were evaluated. PCa, benign prostatic hyperplasia (BPH) patients and healthy controls (HC) showing PSA>4.0ng/ml were enrolled in the study. Their urine samples were obtained, and the urinary levels of putrescine (Put), spermidine (Spd) and spermine (Spm) were determined by ultra-high performance liquid chromatography coupled with triple quadrupole mass spectrometer (UPLC-MS/MS). Receiver operating characteristics (ROC) curve and Student’s t-test were used to evaluate their diagnostic accuracies. Among the three biogenic polyamines, Spm had demonstrated a good diagnostic performance when comparing their levels in PCa patients with BPH patients (1.47 in PCa vs 5.87 in BPH; p<0.0001). Results are in accordance with transrectal ultrasound prostatic biopsy (TRUSPB) results, with an area under curve (AUC) value of 0.83±0.03. Therefore urinary Spm shows potential to serve as a novel PCa diagnostic biomarker, which in turn can help to address the limited sensitivity and specificity problem of serum PSA test. PMID:27598335

  2. DNA/RNA markers for colorectal cancer risk in preserved stool specimens: a pilot study.

    PubMed

    Kato, Ikuko; Badsha, Kawsar Z; Land, Susan; Nechvatal, Jordan M; Matherly, Larry H; Tarca, Adi L; Majumdar, Adhip P; Basson, Marc D; Ram, Jeffrey L

    2009-01-01

    Exfoliated cells in human stool offer excellent opportunities to non-invasively detect molecular markers associated with colorectal tumorigenesis, and to evaluate the effects of exposures to exogenous and endogenous carcinogenic or chemopreventive substances. This pilot study investigated the feasibility of determining DNA methylation and RNA expression simultaneously in stool specimens treated with a single type of nucleic acid preservatives. Stool specimens from 56 volunteers that were preserved up to a week with RNA later were used in this study. Bisulfite sequencing was used to determine methylation at 27 CpG loci on the estrogen receptor 1 (ESR1) promoter. Taqman assay was used for quantitative reverse transcription polymerase chain reactions to measure cyclooxygenase 2 (COX2) and epidermal growth factor receptor (EGFR) mRNA expression. Subjects' basic demographic and other selected risk factors for colorectal cancer were captured through questionnaires and correlated with the levels of these markers. Less than 10% of the samples failed in individual assays. Overall, 24.0% of the CpG loci on the ESR1 promoter were methylated. COX2 expression and alcohol use were positively correlated; an inverse association was present between EGFR expression and cigarette smoking; and subjects using anti-diabetic medication had higher ESR1 methylation. In addition, higher EGFR expression levels were marginally associated with history of polyps and family history of colorectal cancer. The present study demonstrates that simultaneous analyses for DNA and RNA markers are feasible in stool samples treated with a single type of nucleotide preservatives. Among several associations observed, the association between EGFR expression and polyps deserves further investigation as a potential target for colorectal cancer screening. Larger studies are warranted to confirm some of our observations.

  3. Immunization of cancer patients with autologous cancer-derived heat shock protein gp96 preparations: a pilot study.

    PubMed

    Janetzki, S; Palla, D; Rosenhauer, V; Lochs, H; Lewis, J J; Srivastava, P K

    2000-10-15

    Heat shock protein (HSP)-peptide complexes isolated from murine cancers elicit protective immunity and T lymphocytes specific for the cancer from which the HSPs are isolated. A pilot study was designed to test the feasibility, immunogenicity and toxicity of such treatment in cancer patients. Sixteen patients with assorted advanced malignancies, which had become refractory to established therapies, were recruited. The gp96 vaccine was prepared for each patient from tumor obtained from that patient. Anti-tumor immune responses were evaluated using Elispot assays of T cells in peripheral blood after minimal in vitro stimulation. No unacceptable vaccine-related toxicities or auto-immune reactions were observed. Immunization with autologous gp96 elicited MHC I-restricted, tumor-specific CD8(+) T lymphocytes in 6/12 patients immunized. In addition, expansion of the NK cell population was seen in 8/13 of patients immunized. These observations are entirely consistent with the murine experience and form a firm basis for future trials with clinical end points, using autologous, patient-specific HSP-peptide vaccines. Copyright 2000 Wiley-Liss, Inc.

  4. A pilot study to explore circulating tumour cells in pancreatic cancer as a novel biomarker

    PubMed Central

    Khoja, L; Backen, A; Sloane, R; Menasce, L; Ryder, D; Krebs, M; Board, R; Clack, G; Hughes, A; Blackhall, F; Valle, J W; Dive, C

    2012-01-01

    Background: Obtaining tissue for pancreatic carcinoma diagnosis and biomarker assessment to aid drug development is challenging. Circulating tumour cells (CTCs) may represent a potential biomarker to address these unmet needs. We compared prospectively the utility of two platforms for CTC enumeration and characterisation in pancreatic cancer patients in a pilot exploratory study. Patients and methods: Blood samples were obtained prospectively from 54 consenting patients and analysed by CellSearch and isolation by size of epithelial tumour cells (ISET). CellSearch exploits immunomagnetic capture of CTCs-expressing epithelial markers, whereas ISET is a marker independent, blood filtration device. Circulating tumour cell expression of epithelial and mesenchymal markers was assessed to explore any discrepancy in CTC number between the two platforms. Results: ISET detected CTCs in more patients than CellSearch (93% vs 40%) and in higher numbers (median CTCs/7.5 ml, 9 (range 0–240) vs 0 (range 0–144)). Heterogeneity observed for epithelial cell adhesion molecule, pan-cytokeratin (CK), E-Cadherin, Vimentin and CK 7 expression in CTCs may account for discrepancy in CTC number between platforms. Conclusion: ISET detects more CTCs than CellSearch and offers flexible CTC characterisation with potential to investigate CTC biology and develop biomarkers for pancreatic cancer patient management. PMID:22187035

  5. Exercise intervention for fatigue-related symptoms in Thai women with breast cancer: A pilot study.

    PubMed

    Naraphong, Wipasiri; Lane, Adrianne; Schafer, John; Whitmer, Kyra; Wilson, Bradley R A

    2014-03-17

    The purpose of this pilot study was to preliminarily examine the effects of an exercise program on the symptoms of fatigue, sleep disturbance, mood disturbance, symptom distress, and physical fitness for Thai women with breast cancer. Twenty-three eligible women were randomly assigned to either an experimental group (n = 11) or to a control group (n = 12). Data were collected and analyzed at baseline and again at 4, 7, and 10 weeks. At each time point, fatigue was measured at an expected high point during treatment. Participants in the exercise group demonstrated a trend toward improving the symptoms with mean score changes. Using generalized estimating equations analysis, a significant decrease in mood disturbance was found in the exercise group compared with control at 10 weeks (β = 0.03, P = 0.04). The participants exhibited significantly longer 12-minute walk distance at 10 weeks than those in the control group (t = 2.28, P = 0.04). These results indicate that exercise during adjuvant chemotherapy may be beneficial for Thai women with breast cancer. © 2014 Wiley Publishing Asia Pty Ltd.

  6. Home-Telemonitoring Lung Cancer Intervention in Appalachia: A Pilot Study

    PubMed Central

    Chen, YJ; Narsavage, GL; Frick, KD; Petitte, TM

    2016-01-01

    Benefits of home-telemonitoring for rural dwelling cancer patients are largely unknown. This study examined the effectiveness of home-telemonitoring surveillance with nurse coaching for self-management to improve lung cancer outcomes in mountainous Appalachia where health care access/ service is limited. This randomized clinical trial pilot study compared patient outcomes for telemonitoring versus routine care. A convenience sample (N = 47) was enrolled/ randomized (Telemonitored: 26/ Control: 21) from a university hospital and cancer center. Physiologic parameters and symptoms were collected in the telemonitored group for two weeks; all participants were studied for 60 days after the index treatment/ discharge. The telemonitored group showed greater improvement for both functional status (Wald X2 = 3.78, p = .05) and quality of life (QOL) (Wald X2 = 7.25, p = .007) from baseline to 60 days post-discharge. Compared to controls, telemonitored patients survived longer; had more scheduled medical visits (96% vs. 75%); made more unplanned calls to doctors/ nurses (32% vs. 30% & 64% vs. 50%); had fewer rehospitalizations (28% vs. 40%); and had more ER utilization (36% vs. 30%). The telemonitored group had relative improvements for health utility (.09 on a scale where 0 = death/ 1= perfect health) and QOL (15 on 0–100 VAS). Differences in health care utilization and cost were not significantly different (p > .05), likely due to the sample size. Telemonitoring group satisfaction with care was high and recommended by patients and caregivers. Results suggest that it is possible to improve patient outcomes with home-telemonitoring for self-management in rural areas. Short-term, telemonitoring-based coaching is feasible and offers a promising option to develop patient self-management knowledge and skills. PMID:28184382

  7. Microbrachytherapy using holmium-166 acetylacetonate microspheres: a pilot study in a spontaneous cancer animal model.

    PubMed

    Bult, Wouter; Vente, Maarten A D; Vandermeulen, Eva; Gielen, Ingrid; Seevinck, Peter R; Saunders, Jimmy; van Het Schip, Alfred D; Bakker, Chris J G; Krijger, Gerard C; Peremans, Kathelijne; Nijsen, Johannes F W

    2013-01-01

    Holmium-166 acetylacetonate microspheres ((166)Ho-AcAc-MS) are proposed as an intratumoral radioablation device. This article presents a pilot study in housecats with unresectable liver cancer. Feasibility and tolerability of intratumoral administrations of (166)Ho-AcAc-MS was investigated. Three cats with unresectable liver tumors of different histotype were included. One cat had hepatocellular carcinoma (HCC), one had cholangiocarcinoma (CC), and one had a malignant epithelial liver tumor (MELT) of unspecified histotype. (166)Ho-AcAc-MS were injected percutaneously under ultrasound guidance into the tumors. Followup consisted of physical examinations and hematologic and biochemical analyses. (166)Ho-AcAc-MS were administered to three liver tumor-bearing cats. The treatment was well tolerated and the clinical condition, that is body weight, alertness, mobility, and coat condition of the animals improved markedly. Most biochemical and hematologic parameters normalized shortly after treatment. Life of all cats was extended and associated with a good quality of life. The HCC cat that received 33-Gy tumor-absorbed dose was euthanized 6 months after the first administration owing to disease progression. The MELT cat received 99-Gy tumor dose and was euthanized 3 months posttreatment owing to bacterial meningitis. The CC cat received 333Gy and succumbed 4 months after the first treatment owing to the formation of a pulmonary embolism. Percutaneous intratumoral injection of radioactive (166)Ho-AcAc-MS is feasible in liver tumor-bearing cats. The findings of this pilot study indicate that (166)Ho-AcAc-MS may constitute safe brachytherapeutic microspheres and warrant studies to confirm the clinical utility of this novel brachytherapy device. Copyright © 2013 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

  8. Feasibility of transanal endoscopic total mesorectal excision for rectal cancer: results of a pilot study

    PubMed Central

    Oh, Jae Hwan; Park, Sung Chan; Kim, Min Jung; Park, Byung Kwan; Hyun, Jong Hee; Chang, Hee Jin; Han, Kyung Su

    2016-01-01

    Purpose To evaluate the feasibility of transanal total mesorectal excision (TME) in patients with rectal cancer. Methods This study enrolled 12 patients with clinically node negative rectal cancer located 4–12 cm from the anal verge who underwent transanal endoscopic TME with the assistance of single port laparoscopic surgery between September 2013 and August 2014. The primary endpoint was TME quality; secondary endpoints included number of harvested lymph nodes and postoperative complications within 30 days (NCT01938027). Results The 12 patients included 7 males and 5 females, of median age 59 years and median body mass index 24.2 kg/m2. Tumors were located on average 6.7 cm from the anal verge. Four patients (33.3%) received preoperative chemoradiotherapy. Median operating time was 195 minutes and median blood loss was 50 mL. There were no intraoperative complications and no conversions to open surgery. TME was complete or nearly complete in 11 patients (91.7%). Median distal resection and circumferential resection margins were 18.5 mm and 10 mm, respectively. Median number of harvested lymph nodes was 15. Median length of hospital stay was 9 days. There were no postoperative deaths. Six patients experienced minor postoperative complications, including urinary dysfunction in 2, transient ileus in 3, and wound abscess in 1. Conclusion This pilot study showed that high-quality TME was possible in most patients without serious complications. Transanal TME for patients with rectal cancer may be feasible and safe, but further investigations are necessary to evaluate its long-term functional and oncologic outcomes and to clarify its indications. PMID:27757396

  9. Resilience and hope during advanced disease: a pilot study with metastatic colorectal cancer patients.

    PubMed

    Solano, Joao Paulo Consentino; da Silva, Amanda Gomes; Soares, Ivan Agurtov; Ashmawi, Hazem Adel; Vieira, Joaquim Edson

    2016-08-02

    The balance between hope-hopelessness plays an important role in the way terminally ill patients report quality of life, and personal resilience may be related to hope at the end of life. The objective of this study was to explore associations between personal resilience, hope, and other possible predictors of hope in advanced cancer patients. A cross-sectional pilot study was carried out with metastatic colorectal cancer patients in a tertiary hospital. The patients answered the Connor-Davidson Resilience Scale, Herth Hope Index, Barthel Index, an instrument addressing family and social support, visual-numeric scales for pain and suffering, a two-item screening for depression, socio-demographic and socio-economic information about the family. Forty-four patients were interviewed (mean age 56 years; range 29-86). A strong correlation was noted between resilience and hope (0.63; p < 0.05). No correlation was found between hope and independence for activities of daily living, support from family and community, and pain and suffering levels. Of the 44 patients, 20 presented with depressive symptoms. These depressive patients had lower resilience (p = 0.005) and hope (p = 0.003), and higher scores of suffering (p < 0.001). The association between resilience and hope kept stable after adjusting for age, gender, and presence of depression (p < 0.001). Given that resilience is a dynamic, changeable path that can improve hope, resilience-fostering interventions should be most valued in palliative care settings and should be commenced as soon as possible with cancer patients. Patients with advanced stages of non-malignant conditions would also probably benefit from such interventions.

  10. Daily subcutaneous parecoxib injection for cancer pain: an open label pilot study.

    PubMed

    Kenner, David J; Bhagat, Sandeep; Fullerton, Sonia L

    2015-04-01

    Nonsteroidal anti-inflammatory analgesics (NSAIDs) are useful in cancer pain but the specific use of subcutaneous parecoxib has not been previously reported. This pilot study aimed to establish the efficacy and side effect profile of short-term sequential single daily dose subcutaneous parecoxib sodium in patients with severe cancer bone pain. Nineteen hospitalized patients with advanced cancer and uncontrolled malignant bone pain (9 males, 10 females) received 24 courses of one, two, or three days sequential therapy with 'off-label' daily subcutaneous parecoxib. All patients were receiving opioid therapy; the median baseline daily oral equivalent dose (OED) of morphine was 180 mg. Pain was assessed at baseline, 24 hours, 48 hours, and 72 hours. Pain scores as assessed on an 11-point numeric pain rating scale (NPRS), any side effects including subcutaneous site reactions, as well as patient satisfaction rating with analgesia were recorded. A clinically significant decrease in pain scores was defined as a reduction of two or more points on the NPRS. Median pain score of all patient treatments decreased from 7 to 4.5 at 24 hours (p<0.001) and 4.0 at 48 hours. A response was seen in 17 (71%) of the 24 treatments at 24 hours. There was no difference between median negative change in pain scores in 19 (79%) treatments where pain was either strongly movement related, or in 22 (94%) treatments where local bone tenderness was more pronounced. No major side effects were observed during treatment. One patient died from pulmonary embolism after cessation of concurrent prophylactic low molecular weight heparin prior to staging liver biopsy. Subcutaneous site reactions occurred in 2 (8%) treatments and were mild and self limiting. Short-term daily subcutaneous parecoxib injection was effective for malignant bone pain when added to existing analgesic therapy and was well tolerated. Further research is warranted into the short-term use of parecoxib in hospitalized patients with

  11. Screening for body image dissatisfaction in patients with advanced cancer: a pilot study.

    PubMed

    Rhondali, Wadih; Chisholm, Gary B; Filbet, Marilene; Kang, Duck-Hee; Hui, David; Cororve Fingeret, Michelle; Bruera, Eduardo

    2015-02-01

    Cancer and its treatment can significantly affect appearance and body integrity. A number of studies have explored the impact of cancer and its treatment on body image, primarily in head and neck and breast cancer. The aim of this pilot study was to examine the construct of body image dissatisfaction and its measurement using a single question in patients with advanced cancer. Outpatients with advanced cancer were recruited (n=81). Assessments included Body Image Scale (BIS), Appearance Schema Inventory (ASI-R), Edmonton Symptom Assessment System (ESAS) with a total symptom distress score (TSDS) and two subscales scores (physical distress [PHS] and psychological distress [PSS]), Hospital Anxiety Depression Scale (HADS), and one question assessing the overall appearance satisfaction from the Multidimensional Body-Self Relations Questionnaire (MBSRQ). We also asked patients to rate the body image changes importance compared with five symptoms (pain, fatigue, depression, insomnia, lack of appetite). Forty-seven (58%) patients had a BIS score >10 (body image dissatisfaction) with a median of 11 (first-third quartiles, Q1-Q3; 5-16) and a median ASI-R of 3.1 (Q1-Q3; 2.8-3.5). Sensitivity and specificity of ≤3 for body image dissatisfaction in the single overall appearance question using the BIS as a standard was 0.70 and 0.71, respectively. BIS score was significantly correlated with ASI-R (r=0.248; p=0.025), age (r=-0.225; p=0.043), HADS-A (r=0.522, p<0.001), HADS-D (r=0.422, p<0.001), PSS score (r=0.371, p=0.001), PHS score (r=0.356, p=0.001), TSDS score (r=0.416, p<0.001), and the overall appearance question (MBSRQ; r=-0.449, p<0.001). Body image dissatisfaction was frequent and associated with symptom burden. A single item ≤3 has a sensitivity of 70% for body image satisfaction screening.

  12. Screening for Body Image Dissatisfaction in Patients with Advanced Cancer: A Pilot Study

    PubMed Central

    Rhondali, Wadih; Chisholm, Gary B.; Filbet, Marilene; Kang, Duck-Hee; Hui, David; Cororve Fingeret, Michelle

    2015-01-01

    Abstract Background Cancer and its treatment can significantly affect appearance and body integrity. A number of studies have explored the impact of cancer and its treatment on body image, primarily in head and neck and breast cancer. The aim of this pilot study was to examine the construct of body image dissatisfaction and its measurement using a single question in patients with advanced cancer. Methods Outpatients with advanced cancer were recruited (n=81). Assessments included Body Image Scale (BIS), Appearance Schema Inventory (ASI-R), Edmonton Symptom Assessment System (ESAS) with a total symptom distress score (TSDS) and two subscales scores (physical distress [PHS] and psychological distress [PSS]), Hospital Anxiety Depression Scale (HADS), and one question assessing the overall appearance satisfaction from the Multidimensional Body-Self Relations Questionnaire (MBSRQ). We also asked patients to rate the body image changes importance compared with five symptoms (pain, fatigue, depression, insomnia, lack of appetite). Results Forty-seven (58%) patients had a BIS score >10 (body image dissatisfaction) with a median of 11 (first–third quartiles, Q1–Q3; 5–16) and a median ASI-R of 3.1 (Q1–Q3; 2.8–3.5). Sensitivity and specificity of ≤3 for body image dissatisfaction in the single overall appearance question using the BIS as a standard was 0.70 and 0.71, respectively. BIS score was significantly correlated with ASI-R (r=0.248; p=0.025), age (r=−0.225; p=0.043), HADS-A (r=0.522, p<0.001), HADS-D (r=0.422, p<0.001), PSS score (r=0.371, p=0.001), PHS score (r=0.356, p=0.001), TSDS score (r=0.416, p<0.001), and the overall appearance question (MBSRQ; r=−0.449, p<0.001). Conclusion Body image dissatisfaction was frequent and associated with symptom burden. A single item ≤3 has a sensitivity of 70% for body image satisfaction screening. PMID:25188590

  13. ProCEED Pilot Study (Prostate Cancer Study of Ethnicity, Exercise and Diet)

    DTIC Science & Technology

    2008-12-01

    cancer, epidemiology, race, lifestyle risk factors 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF...1) to advance the understanding of the IGF axis and its interplay with race/genetics and dietary/ lifestyle risk factors for prostate cancer, 2) To...attributed, in part, to interactions between lifestyle factors and the IGF axis. This study attempts to elucidate dietary and lifestyle risk factors

  14. Comparison of organochlorine chemical body burdens of female breast cancer cases with cancer free women in Rio Grande do Sul, Brazil--Pilot Study

    SciTech Connect

    Erdmann, C.A.; Petreas, M.X.; Caleffi, M.; Barbosa, F.S.; Goth-Goldstein, R.

    1999-12-01

    This pilot study collected preliminary data to examine known and suspected breast cancer risk factors among women living in rural and urban areas in the state of Rio Grande do Sul, Brazil by questionnaire. In addition, the body burden levels of a panel of organochlorines was measured in a small clinic-based prospective sample.

  15. Weight Lifting in Patients With Lower Extremity Lymphedema Secondary to Cancer: A Pilot and Feasibility Study

    PubMed Central

    Katz, Elana; Dugan, Nicole L; Cohn, Joy C.; Chu, Christina; Smith, Rebecca G.; Schmitz, Kathryn H.

    2010-01-01

    Objective To assess the feasibility of recruiting and retaining cancer survivors with lower limb lymphedema into an exercise intervention study. To develop preliminary estimates regarding the safety and efficacy of this intervention. We hypothesized that progressive weight training would not exacerbate leg swelling and that the intervention would improve functional mobility and quality of life. Design Before-after pilot study of 5 months duration. Setting University of Pennsylvania Participants Cancer survivors with a known diagnosis of lower limb lymphedema (N=10) were directly referred by University of Pennsylvania clinicians. All 10 participants completed the study. Intervention Twice weekly slowly progressive weight-lifting, supervised for 2 months, unsupervised for 3 months. Main Outcome Measures The primary outcome was interlimb volume differences as measured by optoelectronic perometry. Additional outcome measures included safety (adverse events), muscle strength, objective physical function, and quality of life. Results Interlimb volume differences were 44.4 and 45.3% at baseline and 5 months, respectively (pre-post comparison, p = 0.70). There were 2 unexpected incident cases of cellulitus within the first two months. Both resolved with oral antibiotics and complete decongestive therapy by 5 months. Bench and leg press strength increased by 47% and 27% over 5 months (p = 0.001 and p = 0.07, respectively). Distance walked in 6 minutes increased by 7% in 5 months (p = 0.01). No improvement was noted in self-reported quality of life. Conclusions Recruitment of patients with lower limb lymphedema into an exercise program is feasible. Despite some indications that the intervention may be safe (e.g., a lack of clinically significant interlimb volume increases over 5 months), the unexpected finding of two cellulitic infections among the 10 participants suggests additional study is required before concluding lower extremity lymphedema patients can safely perform

  16. Positive schemas, psychopathology, and quality of life in children with pediatric cancer: A pilot study.

    PubMed

    McArthur, Brae Anne; Strother, Douglas; Schulte, Fiona

    2017-01-01

    Research in the area of pediatric oncology has shown that although some children and youth diagnosed with this disease cope adaptively after their diagnosis, others continue to have long-term psychosocial difficulties. The potential mechanisms that may protect against the experience of psychopathology and poor quality of life within this population are not well known. The purpose of this pilot study was to utilize a new comprehensive measure of positive schemas to better understand the relationship between positive schemas, quality of life, and psychopathology, for children on active treatment for cancer. Participants were 22 patients, aged 8-18 years, being treated in a pediatric oncology clinic. Patients and parents completed measures of positive schemas, quality of life, and psychopathology. The mean age at time of initial diagnosis of the patient sample was 11.6 years. Child-reported positive schemas were significantly related to child-reported child quality of life (r = 0.46, p = 0.03). This is the first study to examine positive schemas within a pediatric oncology sample. Future research is needed to further explore facets of positive schemas that may be particularly relevant to child psychological functioning in a pediatric oncology population.

  17. Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

    PubMed

    Koutoukidis, Dimitrios A; Beeken, Rebecca J; Manchanda, Ranjit; Burnell, Matthew; Knobf, M Tish; Lanceley, Anne

    2016-03-10

    Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity. This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention. The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population. ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.

  18. Pilot postoperative ileus study of escin in cancer patients after colorectal surgery.

    PubMed

    Xie, Qiwei; Zong, Xianglong; Ge, Baoming; Wang, Shan; Ji, Jiafu; Ye, Yingjiang; Pan, Lili

    2009-02-01

    Postoperative ileus, a common complication in patients after abdominal surgery, brings no benefit to the recovery of postoperative patients, and treatment targeted at restoring gastrointestinal motility may shorten the hospital stay. Studies have shown that escin accelerates gastrointestinal transit in mice and improves gastrointestinal motility in patients after abdominal surgery. A pilot study of escin's effect on the recovery of gastrointestinal motility was conducted in colorectal cancer patients in anticipation of a multiple-center randomized controlled trial. A total of 72 postoperative colorectal cancer patients were randomly assigned to four parallel groups on the basis of sealed envelopes-escin 5 mg group (E5 mg), escin 15 mg group (E15 mg), escin 25 mg group (E25 mg), and placebo group-with 18 patients in each group. Escin or placebo was diluted in 500 ml 5% dextrose injection, which was given once daily through the subclavian vein. The first injection took place 6 h after completion of the surgery. The treatment continued for 7 days or stopped at the time of the patient's first bowel movement. Time to recovery of passage of gas (TRPG), time to recovery of gastrointestinal sounds (TRGS), and time to recovery of bowel movements (TRBM) were recorded to evaluate the efficacy of escin. The TRPGs of the three escin treatment groups were 76.78 + 28.81 h (E5 mg), 72.06 + 14.65 h (E15 mg), and 65.50 + 26.70 h (E25 mg), respectively, with differences of 6.03 +/- 7.64 h (p = 0.436; E5 mg), 10.75 +/- 4.92 h (p = 0.036; E15 mg), and 17.31 +/- 7.20 h (p = 0.022; E25 mg) compared with the placebo group. The TRGSs of the three escin treatment groups were 45.28 +/- 26.15 h (E5 mg), 41.22 +/- 16.98 h (E15 mg), and 40.33 +/- 14.09 h (E25 mg), respectively, with differences of 4.33 +/- 7.12 h (p = 0.547; E5 mg), 8.39 +/- 5.36 h (p = 0.127; E15 mg), and 9.28 +/- 4.87 h (p = 0.065; E25 mg) compared with the placebo group. The TRBMs of the three escin treatment groups were 89

  19. Extracorporeal Shock Wave Therapy for Breast Cancer-Related Lymphedema: A Pilot Study.

    PubMed

    Cebicci, Mehtap Aykac; Sutbeyaz, Serap Tomruk; Goksu, Sema Sezgin; Hocaoglu, Sehriban; Oguz, Arzu; Atilabey, Ayse

    2016-09-01

    To investigate the clinical effect of extracorporeal shock wave therapy (ESWT) in patients with secondary lymphedema after breast cancer treatment. Prospective clinical pilot study. Education and research hospital. Women with a diagnosis of lymphedema secondary to breast cancer (N=11). Patients were treated for 12 sessions of ESWT with 2500 impulses each. The treatment frequency was 4Hz in multiple shock mode. The energy flow density during treatment was equal to a working pressure of 2 bar. The primary outcome measure was volumetric measurements. The secondary outcome measures were the short version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) and the brief version of the World Health Organization Quality of Life (WHOQOL-BREF). Assessments were conducted by the same investigator at baseline, posttreatment, and at 1, 3, and 6 months after treatment for all patients. Significant reduction was found in the amount of lymphedema with ESWT treatment in all patients, and this reduction was maintained for 6 months. A statistically significant reduction was observed in volumetric measurements for the follow-up period (P=.001). The mean volume displacement of the affected upper extremity before treatment was 870.45±384.19mL at 6 months, and after the treatment it was 604.54±381.74mL. In addition, improvements were observed in the QuickDASH functional assessment tool and in the physical health domain of the WHOQOL-BREF questionnaire (P=.002 and P=.007, respectively). ESWT was shown to provide a reduction in the amount of lymphedema in patients with lymphedema secondary to breast cancer. Also, a marked improvement was observed in the functional status and quality of life of study patients. Treatment efficacy was maintained in the long term. As a noninvasive, novel, and effective method, ESWT is a promising treatment modality for the treatment of lymphedema, which is a chronic, progressive, and refractory condition. Copyright © 2016 American

  20. Feasibility of a Sexual Health Clinic Within Cancer Care: A Pilot Study Using Qualitative Methods.

    PubMed

    Tracy, Myrna; McDivitt, Karmen; Ryan, Maureen; Tomlinson, Jamie; Brotto, Lori A

    2016-01-01

    As cancer survival rates increase, so does the imperative for a satisfying quality of life, including a fulfilling sexual life. The feasibility and effectiveness of a newly formed Sexual Health Clinic were determined using a nurse-led format, which provided support to survivors in a cancer care setting. Twenty-one cancer survivors received assessment, education, and tailored sexual health support by an oncology nurse with specialized skills in sexual health. Two months later, semistructured interviews focused on patients' personal experiences. Questionnaires were also administered to healthcare providers involved in providing the follow-up care. Participants presented with sexual concerns that were psychological, physical, and/or relational. Scores on validated measures of sexual functioning were in the range comparable to those with a sexual dysfunction. Participants were open to being asked about sexual health and wanted professionals available who were skilled in dealing with sexual health services. Most participants experienced an improvement in their well-being and/or sexual life following participation. Some noted more confidence when speaking with their partner about sexual concerns. Our pilot Sexual Health Clinic was feasible, and evidence for its effectiveness was based on qualitative feedback. Participants and providers identified a strong need for the inclusion of sexual health services in cancer care. Oncology nurses are in a key position to initiate discussions surrounding sexual health issues related to cancer treatment. Self-awareness, sensitivity, and a nonjudgmental approach are required to address this dimension of holistic cancer care.

  1. Piloted rover technology study

    NASA Technical Reports Server (NTRS)

    Thrasher, D. L.

    1990-01-01

    This is the May 25, 1990 summary report for Space Transfer Concepts and Analyses (STCA) Study, special study task 9.1, Piloted Rovers Technology Study. Piloted rover concepts, mission scenarios, and the requirements necessary for completion of these missions resulting in the establishment of a lunar base. These tasks were intended to lead to a logical conclusion concerning which piloted rovers technologies are needed to accomplish the various missions, along with a recommended schedule for the development of these technologies.

  2. A Pilot Study to Evaluate the Role of Magnetic Resonance Imaging for Prostate Cancer Screening in the General Population.

    PubMed

    Nam, Robert K; Wallis, Christopher J D; Stojcic-Bendavid, Jessica; Milot, Laurent; Sherman, Christopher; Sugar, Linda; Haider, Masoom A

    2016-08-01

    To our knowledge the role of magnetic resonance imaging as a first line screening test for prostate cancer is unknown. We performed a pilot study to evaluate the feasibility of prostate magnetic resonance imaging as the primary screening test for prostate cancer. We recruited unselected men from the general population. Prostate multiparametric magnetic resonance imaging and random or targeted biopsies were performed in all patients, in addition to prostate specific antigen testing. We compared the performance of prostate magnetic resonance imaging and prostate specific antigen test results to predict prostate cancer. Of the 47 recruited patients 18 (38.3%) had cancer while 29 (61.7%) had no evidence of cancer. The adjusted OR of prostate cancer was significantly higher for magnetic resonance imaging score than for prostate specific antigen level (2.7, 95% CI 1.4-5.4, p = 0.004 vs 1.1, 95% CI 0.9-1.4, p = 0.21). Among the 30 patients with a normal prostate specific antigen (less than 4.0 ng/ml) the positive predictive value in those with a magnetic resonance imaging score of 4 or more was 66.7% (6 of 9) and the negative predictive value in those with a magnetic resonance imaging score of 3 or less was 85.7% (18 of 21, p = 0.004). In this pilot study we determined the feasibility of using multiparametric prostate magnetic resonance imaging as the primary screening test for prostate cancer. Initial results showed that prostate magnetic resonance imaging was better to predict prostate cancer than prostate specific antigen in an unselected sample of the general population. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  3. Next-generation personalised medicine for high-risk paediatric cancer patients - The INFORM pilot study.

    PubMed

    Worst, Barbara C; van Tilburg, Cornelis M; Balasubramanian, Gnana Prakash; Fiesel, Petra; Witt, Ruth; Freitag, Angelika; Boudalil, Miream; Previti, Christopher; Wolf, Stephan; Schmidt, Sabine; Chotewutmontri, Sasithorn; Bewerunge-Hudler, Melanie; Schick, Matthias; Schlesner, Matthias; Hutter, Barbara; Taylor, Lenka; Borst, Tobias; Sutter, Christian; Bartram, Claus R; Milde, Till; Pfaff, Elke; Kulozik, Andreas E; von Stackelberg, Arend; Meisel, Roland; Borkhardt, Arndt; Reinhardt, Dirk; Klusmann, Jan-Henning; Fleischhack, Gudrun; Tippelt, Stephan; Dirksen, Uta; Jürgens, Heribert; Kramm, Christof M; von Bueren, Andre O; Westermann, Frank; Fischer, Matthias; Burkhardt, Birgit; Wößmann, Wilhelm; Nathrath, Michaela; Bielack, Stefan S; Frühwald, Michael C; Fulda, Simone; Klingebiel, Thomas; Koscielniak, Ewa; Schwab, Matthias; Tremmel, Roman; Driever, Pablo Hernáiz; Schulte, Johannes H; Brors, Benedikt; von Deimling, Andreas; Lichter, Peter; Eggert, Angelika; Capper, David; Pfister, Stefan M; Jones, David T W; Witt, Olaf

    2016-09-01

    The 'Individualized Therapy for Relapsed Malignancies in Childhood' (INFORM) precision medicine study is a nationwide German program for children with high-risk relapsed/refractory malignancies, which aims to identify therapeutic targets on an individualised basis. In a pilot phase, reported here, we developed the logistical and analytical pipelines necessary for rapid and comprehensive molecular profiling in a clinical setting. Fifty-seven patients from 20 centers were prospectively recruited. Malignancies investigated included sarcomas (n = 25), brain tumours (n = 23), and others (n = 9). Whole-exome, low-coverage whole-genome, and RNA sequencing were complemented with methylation and expression microarray analyses. Alterations were assessed for potential targetability according to a customised prioritisation algorithm and subsequently discussed in an interdisciplinary molecular tumour board. Next-generation sequencing data were generated for 52 patients, with the full analysis possible in 46 of 52. Turnaround time from sample receipt until first report averaged 28 d. Twenty-six patients (50%) harbored a potentially druggable alteration with a prioritisation score of 'intermediate' or higher (level 4 of 7). Common targets included receptor tyrosine kinases, phosphoinositide 3-kinase-mammalian target of rapamycin pathway, mitogen-activated protein kinase pathway, and cell cycle control. Ten patients received a targeted therapy based on these findings, with responses observed in some previously treatment-refractory tumours. Comparative primary relapse analysis revealed substantial tumour evolution as well as one case of unsuspected secondary malignancy, highlighting the importance of re-biopsy at relapse. This study demonstrates the feasibility of comprehensive, real-time molecular profiling for high-risk paediatric cancer patients. This extended proof-of-concept, with examples of treatment consequences, expands upon previous personalised oncology endeavors

  4. Impact of the breast cancer care measures pilot study on quality-improvement initiatives.

    PubMed

    McGovern-Phalen, Amy M

    2014-01-01

    As a participant in the ONS Foundation-supported Breast Cancer Care Quality Measures Set in 2010, the Edward Cancer Center (ECC) identified gaps in patient assessment. Sleep-wake disturbance and distress were two common areas that were lacking consistent assessment when nurses saw patients during their visits. Another issue is the lack of standard methods of practice or a standardized tool. The ECC, in collaboration with Edward Diabetes Center, Linden Oaks Hospital, and other outpatient offices, adopted the use of the Patient Health Questionnaire-9 depression screening tool. The ECC also modified the intervention recommendations to meet the needs of the oncology population. As a result of the findings in the pilot, the ECC was able to implement an evidence-based practice change to improve the overall quality of patient care and provide earlier intervention in an effort to further improve patient outcomes.

  5. Exercise capacity before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer patients: a pilot study.

    PubMed

    Spruit, Martijn A; Janssen, Paul P; Willemsen, Sonja C P; Hochstenbag, Monique M H; Wouters, Emiel F M

    2006-05-01

    Although lung cancer is a highly prevalent type of cancer, the effects of an inpatient multidisciplinary rehabilitation program on pulmonary function and exercise capacity have never been studied in these patients. Pulmonary function, 6-min walking distance and peak exercise capacity of 10 patients with a severely impaired pulmonary function following treatment of lung cancer were assessed in this pilot study before and after an 8-week inpatient multidisciplinary rehabilitation program. At baseline, patients had a restrictive pulmonary function and an apparent exercise intolerance (median 6-min walking distance: 63.6% predicted; median peak cycling load: 58.5% predicted). Despite the lack of change in median pulmonary function [FEV1: -0.01L, p = 0.5469], functional exercise capacity [145 m; 43.2% of the initial values, p=0.0020] and peak exercise capacity [26 W; 34.4% of the initial values, p = 0.0078] improved significantly compared to baseline. Future trials have to corroborate the present findings. Nevertheless, patients with lung cancer have a clear indication to start a comprehensive rehabilitation program following intensive treatment of their disease. In fact, based on the results of the present pilot study it appears that these patients are good candidates for pulmonary rehabilitation programs.

  6. Performance of a quantitative fecal immunochemical test in a colorectal cancer screening pilot program: a prospective cohort study

    PubMed Central

    Telford, Jennifer; Gentile, Laura; Gondara, Lovedeep; McGahan, Colleen; Coldman, Andrew

    2016-01-01

    Background: British Columbia undertook a colorectal cancer screening pilot program in 3 communities. Our objective was to assess the performance of 2-specimen fecal immunochemical testing in the detection of colorectal neoplasms in this population-based screening program. Methods: A prospective cohort of asymptomatic, average-risk people aged 50 to 74 years completed 2 quantitative fecal immunochemical tests every 2 years, with follow-up colonoscopy if the result of either test was positive. Participant demographics, fecal immunochemical test results, colonoscopy quality indicators and pathology results were recorded. Non-screen-detected colorectal cancer that developed in program participants was identified through review of data from the BC Cancer Registry. Results: A total of 16 234 people completed a first round of fecal immunochemical testing, with a positivity rate of 8.6%; 5378 (86.0% of eligible participants) completed a second round before the end of the pilot program, with a positivity rate of 6.7%. Of the 1756 who had a positive test result, 1555 (88.6%) underwent colonoscopy. The detection rate of colorectal cancer was 3.5 per 1000 participants. The positive predictive value of the fecal immunochemical test was 4.9% (95% confidence interval [CI] 3.8%-6.0%) for colorectal cancer, 35.0% (95% CI 32.5%-37.2%) for high-risk polyps and 62.0% (95% CI 59.6%-64.4%) for all neoplasms. The number needed to screen was 283 to detect 1 cancer, 40 to detect 1 high-risk polyp and 22 to detect any neoplasm. Interpretation: Screening every 2 years with a 2-specimen fecal immunochemical test surpassed the current benchmark for colorectal cancer detection in population-based screening. This study has implications for other jurisdictions planning colorectal cancer screening programs. PMID:28018880

  7. Performance of a quantitative fecal immunochemical test in a colorectal cancer screening pilot program: a prospective cohort study.

    PubMed

    Telford, Jennifer; Gentile, Laura; Gondara, Lovedeep; McGahan, Colleen; Coldman, Andrew

    2016-01-01

    British Columbia undertook a colorectal cancer screening pilot program in 3 communities. Our objective was to assess the performance of 2-specimen fecal immunochemical testing in the detection of colorectal neoplasms in this population-based screening program. A prospective cohort of asymptomatic, average-risk people aged 50 to 74 years completed 2 quantitative fecal immunochemical tests every 2 years, with follow-up colonoscopy if the result of either test was positive. Participant demographics, fecal immunochemical test results, colonoscopy quality indicators and pathology results were recorded. Non-screen-detected colorectal cancer that developed in program participants was identified through review of data from the BC Cancer Registry. A total of 16 234 people completed a first round of fecal immunochemical testing, with a positivity rate of 8.6%; 5378 (86.0% of eligible participants) completed a second round before the end of the pilot program, with a positivity rate of 6.7%. Of the 1756 who had a positive test result, 1555 (88.6%) underwent colonoscopy. The detection rate of colorectal cancer was 3.5 per 1000 participants. The positive predictive value of the fecal immunochemical test was 4.9% (95% confidence interval [CI] 3.8%-6.0%) for colorectal cancer, 35.0% (95% CI 32.5%-37.2%) for high-risk polyps and 62.0% (95% CI 59.6%-64.4%) for all neoplasms. The number needed to screen was 283 to detect 1 cancer, 40 to detect 1 high-risk polyp and 22 to detect any neoplasm. Screening every 2 years with a 2-specimen fecal immunochemical test surpassed the current benchmark for colorectal cancer detection in population-based screening. This study has implications for other jurisdictions planning colorectal cancer screening programs.

  8. Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Pancreatic ductal adenocarcinoma (PDA) is one of the most aggressive malignancies with marked resistance to chemo- and radiotherapy. PDA-cancer stem cells (CSCs) are not targeted by current therapies and may be a reason for poor prognosis. Studies indicate that diets rich in cabbage, broccoli, and cauliflower offer cancer preventative and therapeutic benefits. Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate, sulforaphane, and the polyphenol, quercetin, effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics. The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA. Methods and study design The study is designed as a prospective randomized, double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting. A total number of forty patients (18 years or older) in two parallel groups with advanced, surgically non-resectable PDA under palliative chemotherapy are planned for recruitment. Patients in the treatment group will receive fifteen capsules of the study substance per day (90 mg of active sulforaphane) during the chemotherapy treatment course. Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances (mainly methylcellulose). The follow-up duration is one year. Feasibility of the study substance, adverse effects, and patient compliance, as well as levels of serum tumor markers (CEA, CA 19-9), quality of life, and patient overall survival rates will be assessed at defined points of time. Discussion The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA. The study objectives will provide data on the

  9. Can the coverage of screening for cancer of the cervix be improved using the Electoral Register? A pilot study.

    PubMed

    Cook, G A; Wald, N J

    1985-09-30

    We conducted a pilot study to assess the feasibility using the Electoral Register to carry out a cervical cancer screening programme on a Health District basis. A random sample of 500 names and addresses were drawn from a computerised list of the Electoral Register from three Electoral Wards in Oxford. A pilot study showed that the Electoral Register could be used successfully in this way and that the proportion of women aged 35-64 years who had a cervical smear examination as a result of the screening initiative was increased by a quarter, from 64% to 79%. The numbers of women involved at each step of the screening process were determined, and these may provide a useful guide to others considering implementing similar schemes.

  10. ProCEED Pilot Study (Prostate Cancer Study of Ethnicity, Exercise and Diet)

    DTIC Science & Technology

    2007-12-01

    also most common: hyperlipidemia (52%), erectile dysfunction (33%), Joint pain (27%), diabetes (25%), GERD (19%), arthritis (17%), colon polyps (17...a first degree family member with prostate cancer. A very high proportion of the patients had hypertension (84%). The following comorbidities were...and depression (16%). PROSTATE CANCER CLINICAL INFORMATION Among the 53 prostate cancer cases with complete biopsy and treatment data (3 subjects

  11. Pilot Feasibility Study of a Telephone-Based Couples Intervention for Physical Intimacy and Sexual Concerns in Colorectal Cancer

    PubMed Central

    Reese, Jennifer Barsky; Porter, Laura S.; Somers, Tamara J.; Keefe, Francis J.

    2012-01-01

    No studies have tested interventions addressing the sexual concerns of colorectal cancer patients and their partners. We report findings from a pilot feasibility study of a novel telephone-based Intimacy Enhancement protocol that addresses the intimacy and sexual concerns of couples facing colorectal cancer. Based on a flexible coping model (Reese, Keefe, Somers, & Abernethy, 2010), the intervention was designed to help couples make cognitive and behavioral shifts in their intimate relationships. Eighteen individuals (9 dyads) completed the intervention and completed measures of feasibility (frequency, ease of use, and helpfulness of skills, ratings of rapport), program evaluations, and measures of sexual and relationship functioning. Most participants reported that the intervention was “quite a bit” or “extremely helpful” and that they had used the skills taught within the past week. The skills most commonly practiced and perceived as most helpful tended to be behavioral (e.g., trying a new sexual activity). The largest effect sizes (≥ .60) were found for sexual distress, sexual function (female), and sexual communication. Findings from this pilot study suggest that the Intimacy Enhancement protocol is feasible and holds promise for improving sexual and intimacy outcomes in colorectal cancer patients and their partners. Research and clinical implications are discussed. PMID:22900623

  12. Influence of acupuncture on bioelectrical impedance measures in patients with gastrointestinal cancer: results of a pilot study.

    PubMed

    Grundmann, Oliver; Yoon, Saunjoo L; Williams, Joseph J

    2015-02-01

    Patients with gastrointestinal cancers often suffer from malnutrition and cachexia caused by inflammatory processes due to malignancy and therapeutic intervention. Evaluation of nutritional status and well-being of patients is essential to prevent or slow down the progression of cachexia. In addition, acupuncture as a complementary intervention may help reduce cachexia and unintentional weight loss. Seven patients with cancers of the gastrointestinal tract enrolled in this pilot study were provided with eight acupuncture sessions in addition to their regular treatment schedule. Bioelectrical impedance analysis (BIA) measurements were taken at every other acupuncture session to evaluate the body composition of patients. BIA is a fast, inexpensive and non-invasive method for evaluating fluid, fat and muscle mass distribution which correlates with nutritional status. All patients enrolled in the pilot study completed the acupuncture intervention and BIA measurements. The average weight loss and reduction in body weight was 1.3%, which is less than the average weight loss of 5% reported in the literature. Both phase angle and fat-free mass decreased in patients, indicating a worsening of the condition. However, a shift from intracellular to extracellular fluid was not observed, which is usually associated with a loss of cell integrity. This pilot study indicates that patients tolerate acupuncture treatments well. The BIA results should be interpreted with caution due to the small sample size. A larger randomised placebo-controlled study is currently being conducted to further investigate the influence of acupuncture and to provide insights into BIA as a reliable tool for evaluating body composition in patients with gastrointestinal cancers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Influence of Hatha yoga on physical activity constraints, physical fitness, and body image of breast cancer survivors: a pilot study.

    PubMed

    Van Puymbroeck, Marieke; Schmid, Arlene; Shinew, Kimberly J; Hsieh, Pei-Chun

    2011-01-01

    Breast cancer survivors often experience changes in their perception of their bodies following surgical treatment. These changes in body image may increase self-consciousness and perceptions of physical activity constraints and reduce participation in physical activity. While the number of studies examining different types of yoga targeting women with breast cancer has increased, studies thus far have not studied the influence that Hatha yoga has on body image and physical activity constraints. The objective of this study was to explore the changes that occur in breast cancer survivors in terms of body image, perceived constraints, and physical fitness following an 8-week Hatha yoga intervention. This study used a nonrandomized two-group pilot study, comparing an 8-week Hatha yoga intervention with a light exercise group, both designed for women who were at least nine months post-treatment for breast cancer. Both quantitative and qualitative data were collected in the areas of body image, physical activity constraints, and physical fitness. Findings indicated that quantitatively, yoga participants experienced reductions in physical activity constraints and improvements in lower- and upper-body strength and flexibility, while control participants experienced improvements in abdominal strength and lower-body strength. Qualitative findings support changes in body image, physical activity constraints, and physical fitness for the participants in the yoga group. In conclusion, Hatha yoga may reduce constraints to physical activity and improve fitness in breast cancer survivors. More research is needed to explore the relationship between Hatha yoga and improvements in body image.

  14. Lung cancer in uranium miners: A tissue resource and pilot study. Progress report, September 25, 1992--May 31, 1993

    SciTech Connect

    Samet, J.M.

    1993-05-01

    This project involves two related activities directed toward understanding respiratory carcinogenesis in radon-exposed former uranium miners. The first activity involves a continuation of the tissue resource of lung cancer cases from former underground uranium miners and comparison cases from non-miners. The second activity is a pilot study for a proposed longitudinal study of respiratory carcinogenesis in former uranium miners. The objectives are to facilitate the investigation of molecular changes in radon exposed lung cancer cases and to develop methods for prospectively studying clinical, cytologic, cytogenetic, and molecular changes in the multi-event process of respiratory carcinogenesis, and to assess the feasibility of recruiting former uranium miners into a longitudinal study that collects multiple biologic specimens.

  15. The benefits of medical qigong in patients with cancer: a descriptive pilot study.

    PubMed

    Overcash, Janine; Will, Kathryn M; Lipetz, Debra Weisenburger

    2013-12-01

    Medical Qigong (MQ) is a mind-body exercise that includes movement and meditation and is beneficial in reducing high blood pressure, high cholesterol, anxiety, stress, pain, and incidence of falls. The purpose of the current study was to determine whether patients with cancer and survivors who participated in an MQ class experienced a change in fatigue, depression, and sleep from a preintervention evaluation to a postintervention evaluation. Participants were patients diagnosed with cancer who participated in MQ classes. Some were actively undergoing cancer treatment (e.g., surgery, hormone therapy, radiation therapy, chemotherapy) and some were receiving no treatment. Patients diagnosed with cancer and enrolled in an MQ class were invited to participate. A packet of surveys was completed before the first class and before the final class. Scores showed a reduced depression score after completing the five-week MQ course. Those findings indicate that MQ is helpful in reducing some of the problems associated with cancer and cancer treatment.

  16. Transarterial chemoembolization plus or minus intravenous bevacizumab in the treatment of hepatocellular cancer: A pilot study

    PubMed Central

    2012-01-01

    Background Stimulation of vascular endothelial growth factor (VEGF) has been observed following transarterial chemoembolization (TACE) in hepatocellular cancer (HCC) and may contribute to tumor regrowth. This pilot study examined whether intravenous (IV) bevacizumab, a monoclonal antibody against VEGF, could inhibit neovessel formation after TACE. Methods 30 subjects with HCC undergoing TACE at a single academic institution were randomized with a computer-generated allocation in a one to one ratio to either bevacizumab at a dose of 10 mg/kg IV every 14 days beginning 1 week prior to TACE (TACE-BEV arm) or observation (TACE-O arm). Angiography was performed with TACE at day 8, and again at weeks 10 and 14. Repeat TACE was performed at week 14 if indicated. TACE-BEV subjects were allowed to continue bevacizumab beyond week 16. TACE-O subjects were allowed to cross-over to bevacizumab at week 16 in the setting of progressive disease. The main outcome measure was a comparison of neovessel formation by serial angiography. Secondary outcome measures were progression free survival (PFS) at 16 weeks, overall survival (OS), bevacizumab safety, and an analysis of VEGF levels before and after TACE with and without bevacizumab. Results Among the 30 subjects enrolled, 9 of 15 randomized to the TACE-O arm and 14 of 15 randomized to the TACE-BEV arm completed all 3 angiograms. At week 14, 3 of 9 (33%) TACE-O subjects and 2 of 14 (14%) TACE-BEV subjects demonstrated neovascularity. The PFS at 16 weeks was 0.19 in the TACE-O arm and 0.79 in the TACE-BEV arm (p = 0.021). The median OS was 61 months in the TACE-O arm and 49 months in the TACE-BEV arm (p = 0.21). No life-threatening bevacizumab-related toxicities were observed. There were no substantial differences in bevacizumab pharmacokinetics compared to historical controls. Bevacizumab attenuated the increase in VEGF observed post-TACE. Conclusions IV bevacizumab was well tolerated in selected HCC subjects undergoing TACE, and

  17. Taurine - a possible fingerprint biomarker in non-muscle invasive bladder cancer: A pilot study by 1H NMR spectroscopy.

    PubMed

    Srivastava, Shatakshi; Roy, Raja; Singh, Sudhir; Kumar, Praveen; Dalela, Diwakar; Sankhwar, Satya N; Goel, Apul; Sonkar, Abhinav A

    2010-01-01

    Urinary bladder cancer is a major epidemiological problem that continues to grow each year. It opens avenues for investigative research for the identification of new disease markers and diagnostic techniques. In this pilot study, utility of non-invasive (1)H NMR spectroscopy has been evaluated for probing the metabolic perturbations occurring in non-muscle invasive urinary bladder cancer. (1)H NMR spectra of urine of bladder cancer patients and controls (healthy and urinary tract infection/bladder stone) (n = 103) were acquired at 400MHz. The non-overlapping resonances of citrate, dimethylamine, phenylalanine, taurine and hippurate were first identified and then quantitated by (1)H NMR spectra, with respect to an external reference sodium-3-trimethylsilylpropionate (TSP). The concentrations of these metabolites were then statistically analyzed. The cancer patients showed significant (p < 0.05) variations in concentration of hippurate and citrate as compared with healthy controls and benign controls. The significant elevation in concentration of taurine was observed in urine of bladder cancer patients, which was below the sensitivity limit of 400MHz in control cases. However, stages Ta, T1 and carcinoma in situ (CIS) cannot be differentiated on the basis of altered metabolite indices but their composition may reflect the biochemical alterations in metabolism of cancer cells.

  18. Early referral makes the decision-making about fertility preservation easier: a pilot survey study of young female cancer survivors.

    PubMed

    Kim, Jayeon; Mersereau, Jennifer E

    2015-06-01

    The purpose of the study was to investigate the association between patients' decision-making about fertility preservation (FP) and time between cancer diagnosis and FP consultation in young female cancer survivors. This is a pilot survey study of women aged 18-43 years seen for FP consultation between April 2009 and December 2010. Among 52 women who completed the survey, 15 (29 %) had their FP consultation more than 2 weeks after their cancer diagnosis (late referral group) and 37 (71 %) were within 2 weeks of their cancer diagnosis (early referral group). In univariate analysis, the only difference between the late referral and early referral groups was a higher decisional conflict scale (DCS) in late referral group (p = 0.04). In multivariable analysis, late referral group was more likely to have high DCS (>35) compared to early referral group (odds ratio 4.8, 95 % confidence interval 1.5, 21.6) after adjusting for age, center, and type of cancer. Early referral to a fertility specialist can help patients make better decision about FP. This is the first study to suggest that early referral is important in patients' decision-making process about FP treatment. Our finding supports the benefit of early referral in patients who are interested in FP which is consistent with prior studies about FP referral patterns.

  19. Pilot Study: Fluvoxamine Treatment for Depression and Anxiety Disorders in Children and Adolescents with Cancer

    ERIC Educational Resources Information Center

    Gothelf, Doron; Rubinstein, Maly; Shemesh, Eyal; Miller, Orit; Farbstein, Ilana; Klein, Anat; Weizman, Abraham; Apter, Alan; Yaniv, Isaac

    2005-01-01

    Objective: To evaluate the safety, tolerability, and benefit of fluvoxamine for the treatment of major depressive disorder or anxiety disorders in children and adolescents with cancer. Method: The study was conducted from 2001 to 2004 at a pediatric hematology-oncology center. Fifteen children and adolescents with cancer were treated with…

  20. Pilot Study: Fluvoxamine Treatment for Depression and Anxiety Disorders in Children and Adolescents with Cancer

    ERIC Educational Resources Information Center

    Gothelf, Doron; Rubinstein, Maly; Shemesh, Eyal; Miller, Orit; Farbstein, Ilana; Klein, Anat; Weizman, Abraham; Apter, Alan; Yaniv, Isaac

    2005-01-01

    Objective: To evaluate the safety, tolerability, and benefit of fluvoxamine for the treatment of major depressive disorder or anxiety disorders in children and adolescents with cancer. Method: The study was conducted from 2001 to 2004 at a pediatric hematology-oncology center. Fifteen children and adolescents with cancer were treated with…

  1. Docetaxel and cisplatin as first-line treatment for patients with metastatic esophageal cancer: a pilot study.

    PubMed

    Laack, Eckart; Andritzky, Birte; Dürk, Heinz; Burkholder, Iris; Edler, Lutz; Schuch, Gunter; Boeters, Ina; Görn, Michael; Lipp, Rainer; Horst, Hartmut; Popp, Johann; Hossfeld, Dieter K

    2005-12-01

    We investigated the combination of docetaxel and cisplatin as first-line chemotherapy in patients with metastatic esophageal cancer. 16 chemotherapy-naïve patients with distant metastases were included in the study (15 male, 1 female; median age: 58.5 years (range 37-69); median ECOG performance status: 1). 11 patients (69%) had esophageal cancer, and 5 patients (31%) had cancer of the gastroesophageal junction. Patients received docetaxel 75 mg/m2 and cisplatin 80 mg/m2 on day 1 every 3 weeks. A total of 55 chemotherapy cycles was administered. The median number of cycles was 3 (range 1-6). The overall response rate was 31.3%. 4 out of 10 patients (40%) with squamous cell carcinoma and 1 out of 5 patients (20%) with adenocarcinoma responded to chemotherapy. The median overall survival was 29.6 weeks, and the median progression-free survival was 18.6 weeks. Hematological and non-hematological toxicities were moderate (neutropenia WHO grade III/IV: 42.9%, alopecia grade II/III: 64.3%, nausea/vomiting grade II/III: 57.2%, neurotoxicity grade II: 14.3%). The combination of docetaxel and cisplatin is an active regimen with moderate toxicity in the treatment of patients with metastatic esophageal cancer. This pilot study demonstrates the feasibility of a combination treatment containing a taxane and cisplatin in metastatic esophageal cancer.

  2. Response to "Secondary Exposure of Family Members to Cyclophosphamide After Chemotherapy of Outpatients With Cancer: A Pilot Study".

    PubMed

    2016-05-01

    Near panic around secondary exposure of staff and family members to chemotherapy products is being seen again in spite of the implementation of products and procedures that have been shown to decrease the incidence in these populations. Many erroneous statements surrounding the extent of inadvertent chemotherapy exposure can be found in patient education sheets, in American Cancer Society publications, and, of course, on the Internet.
 Therefore, it was with a sense of relief at finally finding a voice of reason that I turned to "Secondary Exposure of Family Members to Cyclophosphamide After Chemotherapy of Outpatients With Cancer: A Pilot Study."
 However, I was sadly disappointed for the following reasons.
.

  3. Exercise stage of change, barriers, expectations, values and preferences among breast cancer patients during treatment: a pilot study.

    PubMed

    Rogers, L Q; Courneya, K S; Shah, P; Dunnington, G; Hopkins-Price, P

    2007-01-01

    With increasing evidence supporting physical activity benefits during breast cancer treatment, addressing exercise adherence with consideration of the unique exercise barriers, outcome expectations and preferences of cancer patients is needed. Our pilot study aimed to determine the following during breast cancer treatment: (1) exercise barriers, outcome expectations/values and associations with exercise stage of change and (2) exercise preferences. A cross-sectional survey was administered to 23 breast cancer patients during treatment. Participants were primarily aged 50-60 years (52%), Caucasian (91%), with stage I (30%), II (44%) or III (26%) disease. A total of 48% were receiving chemotherapy. In total, 50% were in the pre-contemplation/contemplation stage of change, with 34% in action/maintenance. Common exercise adherence barriers (i.e. lack of priority, self-discipline, procrastination and fatigue) demonstrated statistically significant negative associations with exercise. Frequent outcome expectations included improving heart/lungs, reducing disease risk, building muscle strength and losing weight. Important outcomes included improving state of mind, reducing fatigue and avoiding injury. Outcome expectations (i.e. less depression, boredom and nausea) were positively associated with exercise. The majority preferred walking (100%), moderate-intensity (61%), home-based (78%) exercise. Among breast cancer patients during treatment, exercise adherence barriers are general and disease specific. Outcome expectations are physical benefits, with the most important outcomes being psychological or avoidance of risk (i.e. injury).

  4. Preclinical and Pilot Clinical Studies of Docetaxel Chemoradiation for Stage III Non-Small-Cell Lung Cancer

    SciTech Connect

    Chen Yuhchyau; Pandya, Kishan J.; Hyrien, Ollivier; Keng, Peter C.; Smudzin, Therese; Anderson, Joy; Qazi, Raman; Smith, Brian; Watson, Thomas J.; Feins, Richard H.; Johnstone, David W.

    2011-08-01

    Purpose: Local and distant failure rates remain high despite aggressive chemoradiation (CRT) treatment for Stage III non-small-cell lung cancer. We conducted preclinical studies of docetaxel's cytotoxic and radiosensitizing effects on lung cancer cell lines and designed a pilot study to target distant micrometastasis upfront with one-cycle induction chemotherapy, followed by low-dose radiosensitizing docetaxel CRT. Methods and Materials: A preclinical study was conducted in human lung cancer cell lines NCI 520 and A549. Cells were treated with two concentrations of docetaxel for 3 h and then irradiated immediately or after a 24-h delay. A clonogenic survival assay was conducted and analyzed for cytotoxic effects vs. radiosensitizing effects of docetaxel. A pilot clinical study was designed based on preclinical study findings. Twenty-two patients were enrolled with a median follow-up of 4 years. Induction chemotherapy consisted of 75 mg/m{sup 2} of docetaxel and 75 mg/m{sup 2} of cisplatin on Day 1 and 150 mg/m{sup 2} of recombinant human granulocyte colony-stimulating factor on Days 2 through 10. Concurrent CRT was started 3 to 6 weeks later with twice-weekly docetaxel at 10 to 12 mg/m{sup 2} and daily delayed radiation in 1.8-Gy fractions to 64.5 Gy for gross disease. Results: The preclinical study showed potent cytotoxic effects of docetaxel and subadditive radiosensitizing effects. Delaying radiation resulted in more cancer cell death. The pilot clinical study resulted in a median survival of 32.6 months for the entire cohort, with 3- and 5-year survival rates of 50% and 19%, respectively, and a distant metastasis-free survival rate of 61% for both 3 and 5 years. A pattern-of-failure analysis showed 75% chest failures and 36% all-distant failures. Therapy was well tolerated with Grade 3 esophagitis observed in 23% of patients. Conclusions: One-cycle full-dose docetaxel/cisplatin induction chemotherapy with recombinant human granulocyte colony-stimulating factor

  5. Examining cultural factors that influence treatment decisions: a pilot study of Latino men with cancer.

    PubMed

    Carrion, Iraida V; Nedjat-Haiem, Frances R; Marquez, David X

    2013-12-01

    The objective of this study was to explore beliefs and treatment decisions of foreign-born Latino men from Cuba, Mexico, Colombia, and Venezuela, who have been diagnosed with cancer and who live in Central Florida, USA. Experiences related to knowledge of diagnosis, treatment decisions, communication with health providers, family involvement, and advance care planning (ACP) discussions following the diagnosis of cancer are central to this study. This study used qualitative in-depth semi-structured interviews and thematic analysis. The interviews were conducted with 15 Latino men who have been diagnosed with cancer within the past 5 years and who reside in the community. The interviews were conducted and transcribed in Spanish and then translated into English. The median age was 55.4 years. Nine Latino men had prostate cancer, two had brain cancer, two had colorectal cancer, and two had lung cancer. Emerging themes involved the suddenness of the diagnosis, fear of dying, expectations of diagnosis-related communication, reliance on physicians for treatment decisions, limited information pertaining to ACP, family support, and role changes. Latino men's limited knowledge of cancer diagnosis and treatment options coupled with their fear led them to immediately believe that they were going to die. Knowledge gaps regarding diagnosis-related communication, treatment decisions, and ACP varied among the men. The forthright diagnosis communication and the expectation to engage in decision making are contrary to Latinos men's beliefs of reliance on health providers decisions. The findings contribute to understanding Latino men's beliefs about a cancer diagnosis and treatment decisions.

  6. Cervical cancer: does our message promote screening? A pilot study in a South African context.

    PubMed

    Maree, Johanna E; Wright, Susanna C D

    2011-04-01

    The purpose of the study was to explore if cervical cancer information presented in a non-stigmatizing manner could promote screening in women living in a resource poor environment in Tshwane, South Africa. An exploratory, contextual, quantitative door-to-door survey was conducted. The sampling method was convenience (n = 105). Structured interviews were used to gather self-reported data. Chi-square tests were used for secondary data analyses. The study provided evidence that presenting information on cervical cancer in a non-stigmatizing manner based on the theme of self protection promoted cervical screening. The study further provided evidence that women preferred a cervical cancer message that does not focus on the sexual risk factors of this disease. More than a third of the sample preferring a message introducing cervical cancer as a sexually transmitted infection (n = 32) were of the opinion that this message were stigmatizing, blameful and displayed misunderstanding of their lives. Cervical cancer screening is indeed not simple. The screening rate not only in South Africa but many other countries serves as proof. It can therefore not be afforded to add to the barriers by presenting information on cervical cancer in a way perceived as stigmatizing and blameful. Presenting information in way that women prefer might not only promote cervical screening, but might motivate them in such a way that they are screened. Copyright © 2010 Elsevier Ltd. All rights reserved.

  7. Effect of an essential oil mixture on skin reactions in women undergoing radiotherapy for breast cancer: a pilot study.

    PubMed

    Halm, Margo A; Baker, Clarice; Harshe, Val

    2014-12-01

    This pilot study compared the effects of an essential oil mixture versus standard care on skin reactions in breast cancer patients receiving radiation. Using an experimental design, 24 patients were randomized to standard care (i.e., RadiaPlexRx™ ointment) or an essential oil mixture. Products were applied topically three times a day until 1 month postradiation. Weekly skin assessments were recorded and women completed patient satisfaction and quality of life (QOL) instruments at 3-, 6-, and 10-week intervals. No significant differences were found for skin, QOL, or patient satisfaction at interim or follow-up time points. Effect sizes were as follows: skin = .01 to .07 (small-medium effect); QOL = .01 to .04 (small effect); patient satisfaction = .02 (small effect). The essential oil mixture did not provide a better skin protectant effect than standard care. These findings suggest the essential oil mixture is equivalent to RadiaPlexRx, a common product used as standard care since it has been shown to be effective in protecting skin from radiation. Thus, this pilot provides evidence to support botanical or nonpharmaceutical options for women during radiotherapy for breast cancer. © The Author(s) 2014.

  8. Helping Her Heal: a pilot study of an educational counseling intervention for spouses of women with breast cancer.

    PubMed

    Lewis, Frances Marcus; Cochrane, Barbara B; Fletcher, Kristin A; Zahlis, Ellen H; Shands, Mary Ellen; Gralow, Julie R; Wu, Salene M; Schmitz, KrisAnn

    2008-02-01

    Breast cancer is known to cause substantial anxiety, depressed mood, and diminished marital functioning in the diagnosed woman's spouse. Despite the scope and magnitude of these issues, few intervention studies have included spouses or addressed the causes of their lower functioning. The purpose of this pilot study was to evaluate the short-term impact of a 5-session, clinic-based, educational counseling intervention for spouses whose wife was recently diagnosed with early stage breast cancer. The goals of the intervention were to enhance spouses' skills and confidence to communicate and interpersonally support his wife about the breast cancer as well as improve spouses' self-care, depressed mood, anxiety, and marital adjustment. Pre-post-test results obtained from 20 spouses from valid and reliable standardized questionnaires showed significant improvements in spouses' depressed mood, anxiety, skills, self-confidence, and self-care. Confidential post-intervention interviews with spouses and wives included detailed examples of positive changes in the spouse's communication and support to his wife about the breast cancer, diminished tension in the spouse, and improved quality in the couple's relationship. Further evaluation of the Helping Her Heal Program is warranted within a clinical trial.

  9. A study of airline pilot morbidity.

    PubMed

    Sykes, Adrian J; Larsen, Peter D; Griffiths, Robin F; Aldington, Sarah

    2012-10-01

    It has long been believed that airline pilots are healthier than the general population. There are a number of reasons why this should be the case. However, there is very little evidence to support this belief as fact. This study investigates the health of the pilot population of an Oceanic based airline compared to the health of the general population. Pilots who conducted their medical certificate renewal at the airline's medical unit between 1 November 2009 and 31 October 2010 were included. A medical questionnaire was completed by each pilot at the time of their medical certificate renewal. Data from the questionnaire was entered into a database as well as the pilot's BMI, blood pressure, lipid profile, and blood glucose level. The comparison population was the population who completed the New Zealand Health Survey (NZHS) between 2006-2007. Demographic, lifestyle characteristics, and health status data from the pilots was compared to the NZHS using a Chi-squared test. Included in the study were 595 pilots. With respect to most medical conditions, pilots had a lower prevalence when compared to the general population. Pilots had a higher prevalence of kidney disease (3.3% vs 0.6%) and melanoma skin cancer (19 per 1000 vs 0.4 per 1000). This study suggests that pilots in New Zealand are healthier than the general population with respect to most medical conditions. The two medical conditions that were identified as being overrepresented in pilots may be the result of the occupational environment.

  10. Chemotherapy for elderly patients with advanced cancer: A pilot study in Institute of Oncology Bucharest

    PubMed Central

    Grigorescu, Alexandru C.

    2015-01-01

    Objectives First objective was better understanding of the indications of chemotherapy in elderly with advanced cancer, tolerability and toxicity of chemotherapy in this age group. The second objective was to define current practice in chemotherapy for elderly people with advanced cancer for a selected group of patients treated in Institute of Oncology Bucharest (IOB). Materials and Methods The study makes a clinical analysis of medical records of 27 patients from the archive of Institute of Oncology Bucharest treated by the same doctor. Patients were selected according to: age ≥ 65 years, ECOG performance status 0–1, normal blood counts and blood biochemistry, histological confirmation of the diagnosis of cancer, patients should received at least 3 cycles of chemotherapy. We extract characteristics of the patients to see if they were a homogeneous group of patients and to compare them with data from the literature. Overall survival was calculated by the Kaplan Meyer curve. Results 295 patients more then 65 years were treated in our site in 2 years 2011, 2012. 93 patients received chemotherapy and only 27 patients were enrolled in this study following inclusion criteria. Common sites of cancer were lung and breast. The most used cytostatics for lung cancer was gemcitabine and carboplatine and cyclophosphamide, metotrexat and 5 fluorouracil for breast cancer. Toxicity was mild with the prevalence of hematologic toxicity. Overall survival without taking into account the type of cancer was 27.7 month. Conclusions For selected patients, chemotherapy was well tolerated and appears to prolong survival regardless of the location of cancer. The relatively small number of elderly patients who received chemotherapy is probably due to lack of compliance to treatment, the increased number of co-morbidities and evaluation of performance status only by the ECOG index known not to be good enough to establish the indication of chemotherapy. PMID:27847881

  11. Salvage intraperitoneal chemotherapy for relapsed type II endometrial cancer: A pilot case-control study

    PubMed Central

    Tsai, Yi-Chen; Chang, Yen-Hou; Yi-Chang; Chuang, Chi-Mu

    2016-01-01

    Objective Epithelial ovarian cancer and relapsed type II endometrial cancer share common characteristics. Although the role of intraperitoneal (IP) chemotherapy in the treatment of epithelial ovarian cancer has been well-established, its role in the treatment of relapsed type II endometrial cancer remains to be elucidated. Material and Methods From January 2000 to December 2012, patients who were diagnosed with relapsed type II endometrial cancer and underwent secondary cytoreductive surgery, patients with residual tumors less than 1 cm in diameter were initially screened for this study. Of the screened patients, consecutive patients who received salvage IP chemotherapy (IP platinum plus intravenous paclitaxel) were considered the case group. The case study group was matched to a control group that was composed of patients who received salvage systemic chemotherapy (intravenous platinum plus intravenous paclitaxel) in a 1:2 ratio. The overall survival was compared between the case group and the control group, and the IP treatment-related toxicities were reported. Results In total, 11 patients were assigned into the case group and 22 patients were assigned into the control group. The median overall survival (95% confidence interval) was 40.5 (25.5–56.2) months for the case group versus 28.0 (18.0–37.0) for the control group (hazard ratio=0.37 (95% confidence interval, 0.15–0.95); p=0.032, by the log-rank test). The most commonly observed toxicity was of gastrointestinal origin (81.8%). Toxicities that stemmed from hematological, cardiovascular, neurological, and catheter-related complications were similar to results published in other studies on IP chemotherapy for ovarian cancer. Conclusion Salvage IP chemotherapy may potentially confer a longer overall survival than conventional systemic chemotherapy in the treatment of relapsed type II endometrial cancer. PMID:27990084

  12. Salvage intraperitoneal chemotherapy for relapsed type II endometrial cancer: A pilot case-control study.

    PubMed

    Tsai, Yi-Chen; Chang, Yen-Hou; Yi-Chang; Chuang, Chi-Mu

    2016-01-01

    Epithelial ovarian cancer and relapsed type II endometrial cancer share common characteristics. Although the role of intraperitoneal (IP) chemotherapy in the treatment of epithelial ovarian cancer has been well-established, its role in the treatment of relapsed type II endometrial cancer remains to be elucidated. From January 2000 to December 2012, patients who were diagnosed with relapsed type II endometrial cancer and underwent secondary cytoreductive surgery, patients with residual tumors less than 1 cm in diameter were initially screened for this study. Of the screened patients, consecutive patients who received salvage IP chemotherapy (IP platinum plus intravenous paclitaxel) were considered the case group. The case study group was matched to a control group that was composed of patients who received salvage systemic chemotherapy (intravenous platinum plus intravenous paclitaxel) in a 1:2 ratio. The overall survival was compared between the case group and the control group, and the IP treatment-related toxicities were reported. In total, 11 patients were assigned into the case group and 22 patients were assigned into the control group. The median overall survival (95% confidence interval) was 40.5 (25.5-56.2) months for the case group versus 28.0 (18.0-37.0) for the control group (hazard ratio=0.37 (95% confidence interval, 0.15-0.95); p=0.032, by the log-rank test). The most commonly observed toxicity was of gastrointestinal origin (81.8%). Toxicities that stemmed from hematological, cardiovascular, neurological, and catheter-related complications were similar to results published in other studies on IP chemotherapy for ovarian cancer. Salvage IP chemotherapy may potentially confer a longer overall survival than conventional systemic chemotherapy in the treatment of relapsed type II endometrial cancer.

  13. Pilot clinical study for quantitative spectral diagnosis of non-melanoma skin cancer

    PubMed Central

    Rajaram, Narasimhan; Reichenberg, Jason S.; Migden, Michael R.; Nguyen, Tri H.

    2010-01-01

    Background Several research groups have demonstrated the non-invasive diagnostic potential of diffuse optical spectroscopy (DOS) and laser-induced fluorescence (LIF) techniques for early cancer detection. By combining both modalities, one can simultaneously measure quantitative parameters related to the morphology, function and biochemical composition of tissue and use them to diagnose malignancy. The objective of this study was to use a quantitative reflectance/fluorescence spectroscopic technique to determine the optical properties of normal skin and non-melanoma skin cancers and the ability to accurately classify them. An additional goal was to determine the ability of the technique to differentiate non-melanoma skin cancers from normal skin. Study Design The study comprised 48 lesions measured from 40 patients scheduled for a biopsy of suspected non-melanoma skin cancers. White light reflectance and laser-induced fluorescence spectra (wavelength range = 350–700 nm) were collected from each suspected lesion and adjacent clinically normal skin using a custom-built, optical fiber-based clinical instrument. After measurement, the skin sites were biopsied and categorized according to histopathology. Using a quantitative model, we extracted various optical parameters from the measured spectra that could be correlated to the physiological state of tissue. Results Scattering from cancerous lesions was significantly lower than normal skin for every lesion group, whereas absorption parameters were significantly higher. Using numerical cut-offs for our optical parameters, our clinical instrument could classify basal cell carcinomas with a sensitivity and specificity of 94 and 89%, respectively. Similarly, the instrument classified actinic keratoses and squamous cell carcinomas with a sensitivity of 100% and specificity of 50%. Conclusion The measured optical properties and fluorophore contributions of normal skin and non-melanoma skin cancers are significantly different

  14. A pilot study using metagenomic sequencing of the sputum microbiome suggests potential bacterial biomarkers for lung cancer.

    PubMed

    Cameron, Simon J S; Lewis, Keir E; Huws, Sharon A; Hegarty, Matthew J; Lewis, Paul D; Pachebat, Justin A; Mur, Luis A J

    2017-01-01

    Lung cancer (LC) is the most prevalent cancer worldwide, and responsible for over 1.3 million deaths each year. Currently, LC has a low five year survival rates relative to other cancers, and thus, novel methods to screen for and diagnose malignancies are necessary to improve patient outcomes. Here, we report on a pilot-sized study to evaluate the potential of the sputum microbiome as a source of non-invasive bacterial biomarkers for lung cancer status and stage. Spontaneous sputum samples were collected from ten patients referred with possible LC, of which four were eventually diagnosed with LC (LC+), and six had no LC after one year (LC-). Of the seven bacterial species found in all samples, Streptococcus viridans was significantly higher in LC+ samples. Seven further bacterial species were found only in LC-, and 16 were found only in samples from LC+. Additional taxonomic differences were identified in regards to significant fold changes between LC+ and LC-cases, with five species having significantly higher abundances in LC+, with Granulicatella adiacens showing the highest level of abundance change. Functional differences, evident through significant fold changes, included polyamine metabolism and iron siderophore receptors. G. adiacens abundance was correlated with six other bacterial species, namely Enterococcus sp. 130, Streptococcus intermedius, Escherichia coli, S. viridans, Acinetobacter junii, and Streptococcus sp. 6, in LC+ samples only, which could also be related to LC stage. Spontaneous sputum appears to be a viable source of bacterial biomarkers which may have utility as biomarkers for LC status and stage.

  15. A culturally adapted family intervention for African American families coping with parental cancer: outcomes of a pilot study.

    PubMed

    Davey, Maureen P; Kissil, Karni; Lynch, Laura; Harmon, La-Rhonda; Hodgson, Nancy

    2013-07-01

    The primary objective of this 2-year pilot study was to evaluate the effectiveness of a culturally adapted family intervention in improving family communication among African American parents coping with cancer and their school-age children. A secondary objective was to determine its impact on other symptoms of psychosocial distress (depression and anxiety). The third objective was to assess for acceptability and feasibility. Using a two-arm pre-intervention and post-intervention prospective design, 12 African American families received five bi-monthly sessions of either a culturally adapted family intervention (n=7 families) or psycho-education treatment (n=5 families). Parents and their children completed pre-intervention and post-intervention questionnaires assessing perceptions of family communication, quality of their relationship, and symptoms of depression. School-age children additionally completed a questionnaire assessing their levels of anxiety. Consumer satisfaction was also evaluated at post-intervention. Parents and school-age children who completed the culturally adapted family intervention reported significantly better communication with each other and were more satisfied compared with the psycho-education control group. No changes were noted in symptoms of anxiety or depression. The culturally adapted family intervention was acceptable based on our findings, families' feedback, and rates of retention. Feasibility is uncertain because our oncology clinic approach to recruitment was slower than expected. Providing culturally adapted family intervention programs to African American families who are coping with parental cancer may result in improved family communication. This pilot study serves as the first step in the development of culturally adapted family intervention programs to help African American families cope with parental cancer. Copyright © 2012 John Wiley & Sons, Ltd.

  16. Spiritual care of cancer patients by integrated medicine in urban green space: a pilot study.

    PubMed

    Nakau, Maiko; Imanishi, Jiro; Imanishi, Junichi; Watanabe, Satoko; Imanishi, Ayumi; Baba, Takeshi; Hirai, Kei; Ito, Toshinori; Chiba, Wataru; Morimoto, Yukihiro

    2013-01-01

    Psycho-oncological care, including spiritual care, is essential for cancer patients. Integrated medicine, a therapy combining modern western medicine with various kinds of complementary and alternative medicine, can be appropriate for the spiritual care of cancer because of the multidimensional characteristics of the spirituality. In particular, therapies that enable patients to establish a deeper contact with nature, inspire feelings of life and growth of plants, and involve meditation may be useful for spiritual care as well as related aspects such as emotion. The purpose of the present study was to examine the effect of spiritual care of cancer patients by integrated medicine in a green environment. The present study involved 22 cancer patients. Integrated medicine consisted of forest therapy, horticultural therapy, yoga meditation, and support group therapy, and sessions were conducted once a week for 12 weeks. The spirituality (the Functional Assessment of Chronic Illness Therapy-Spiritual well-being), quality of life (Short Form-36 Health Survey Questionnaire), fatigue (Cancer Fatigue Scale), psychological state (Profile of Mood States, short form, and State-Trait Anxiety Inventory) and natural killer cell activity were assessed before and after intervention. In Functional Assessment of Chronic Illness Therapy-Spiritual well-being, there were significant differences in functional well-being and spiritual well-being pre- and postintervention. This program improved quality of life and reduced cancer-associated fatigue. Furthermore, some aspects of psychological state were improved and natural killer cell activity was increased. It is indicated that integrated medicine performed in a green environment is potentially useful for the emotional and spiritual well-being of cancer patients. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Quantitative Multiparametric MRI Features and PTEN Expression of Peripheral Zone Prostate Cancer: A Pilot Study.

    PubMed

    McCann, Stephanie M; Jiang, Yulei; Fan, Xiaobing; Wang, Jianing; Antic, Tatjana; Prior, Fred; VanderWeele, David; Oto, Aytekin

    2016-03-01

    The objective of our study was to investigate associations between quantitative image features of multiparametric MRI of the prostate and PTEN expression of peripheral zone prostate cancer. A total of 45 peripheral zone cancer foci from 30 patients who had undergone multiparametric prostate MRI before prostatectomy were identified by a genitourinary pathologist and a radiologist who reviewed histologic findings and MR images. Histologic sections of cancer foci underwent immunohistochemical analysis and were scored according to the percentage of tumor-positive cells expressing PTEN as negative (0-20%), mixed (20-80%), or positive (80-100%). Average and 10th percentile apparent diffusion coefficient (ADC) values, skewness of T2-weighted signal intensity histogram, and quantitative perfusion parameters (i.e., forward volume transfer constant [K(trans)], extravascular extracellular volume fraction [ve], and reverse reflux rate constant between the extracellular space and plasma [k(ep)]) from the Tofts model were calculated for each cancer focus. Associations between the quantitative image features and PTEN expression were analyzed with the Spearman rank correlation coefficient (r). Analysis of the 45 cancer foci revealed that 21 (47%) were PTEN-positive, 12 (27%) were PTEN-negative, and 12 (27%) were mixed. There was a weak but significant negative correlation between Gleason score and PTEN expression (r = -0.30, p = 0.04) and between k(ep) and PTEN expression (r = -0.35, p = 0.02). There was no significant correlation between other multiparametric MRI features and PTEN expression. This preliminary study of radiogenomics of peripheral zone prostate cancer revealed weak-but significant-associations between the quantitative dynamic contrast-enhanced MRI feature k(ep) and Gleason score with PTEN expression. These findings warrant further investigation and validation with the aim of using multiparametric MRI to improve risk assessment of patients with prostate cancer.

  18. Stereo display of CT images for lung cancer screening: a pilot study

    NASA Astrophysics Data System (ADS)

    Wang, Xiao Hui; Durick, Janet E.; Herbert, David L.; Lu, Amy; Golla, Sarawathi K.; Shinde, Dilip D.; Piracha, Samaia; Foley, Kristin; Fuhrman, Carl R.; Shindel, Betty E.; Leader, J. Ken; Good, Walter F.

    2007-03-01

    To improve radiologist's performance in lesion detection and diagnosis on 3D medical image dataset, we have conducted a pilot study to test viability and efficiency of the stereo display for lung nodule detection and classification. Using our previously developed stereo compositing methods, stereo image pairs were prestaged and precalculated from CT slices for real-time interactive display. Three display modes (i.e., stereoscopic 3D, orthogonal MIP and slice-by-slice) were compared for lung nodule detection and total of eight radiologists have participated this pilot study to interpret the images. The performance of lung nodule detection was analyzed and compared between the modes using FROC analysis. Subjective assessment indicates that stereo display was well accepted by the radiologists, despite some uncertainty of beneficial results due to the novelty of the display. The FROC analysis indicates a trend that, among the three display modes, stereo display resulted in the best performance of nodule detection followed by slice-based display, although no statistically significant difference was shown between the three modes. The stereo display of a stack of thin CT slices has the potential to clarify three-dimensional structures, while avoiding ambiguities due to tissue superposition. Few studies, however, have addressed actual utility of stereo display for medical diagnosis. Our preliminary results suggest a potential role of stereo display for improving radiologists' performance in medical detection and diagnosis, and also indicate some factors likely affect the performance with new display, such as novelty of the display, training effect from projected radiography interpretation and confidence with the new technology.

  19. [Sentinel node biopsy in patients with oral cancer: a pilot study].

    PubMed

    Anmella, Joaquín; Fraile, Manuel; Salavert, Agustí; Bara, Javier; Vallejos, Virginia; Riba, Joaquín; Solá, Montserrat; Castellà, Eva; Alastrué, Antoni

    2003-10-11

    Sentinel node (SN) biopsy represents an alternative to full lymph node dissection in the surgical treatment of several malignant tumors. Prospective study of 32 consecutive patients with clinically node-negative oral cancer comparing SN biopsy results with standard neck dissection. An effective SN localization was achieved in 31 patients (97%) and a complete agreement with neck dissection was observed: 16 were true negative and 15 were true positive. In 11 out of the 15 positive cases, the SN was the only node containing metastasis (73%). SN biopsy predicts the subclinical lymph node status in oral cancer patients.

  20. Pilot study: fluvoxamine treatment for depression and anxiety disorders in children and adolescents with cancer.

    PubMed

    Gothelf, Doron; Rubinstein, Maly; Shemesh, Eyal; Miller, Orit; Farbstein, Ilana; Klein, Anat; Weizman, Abraham; Apter, Alan; Yaniv, Isaac

    2005-12-01

    To evaluate the safety, tolerability, and benefit of fluvoxamine for the treatment of major depressive disorder or anxiety disorders in children and adolescents with cancer. The study was conducted from 2001 to 2004 at a pediatric hematology-oncology center. Fifteen children and adolescents with cancer were treated with fluvoxamine 100 mg/day in an open prospective 8-week trial. Safety and tolerability were evaluated at baseline and at weeks 4 and 8 by blood tests and the Side Effects Checklist. Clinical benefit was assessed with the Clinical Global Impressions-Improvement, the Children's Depression Rating Scale-Revised, and the Pediatric Anxiety Rating Scale. Fluvoxamine was well tolerated by all subjects. Psychiatric symptoms improved significantly. In this open trial, fluvoxamine appeared to be well tolerated and was associated with a promising reduction in the depression and anxiety symptoms of pediatric patients with cancer.

  1. Impact of preoperative immunonutrition on morbidity following cystectomy for bladder cancer: a case-control pilot study.

    PubMed

    Bertrand, J; Siegler, N; Murez, T; Poinas, G; Segui, B; Ayuso, D; Gres, P; Wagner, L; Thuret, R; Costa, P; Droupy, S

    2014-02-01

    To compare postoperative complications in patients with or without preoperative immunonutrition before cystectomy. A prospective, multicenter, pilot, case-control study was conducted during 6 months. Patients with 7-day preoperative immunonutrition were prospectively included and compared with a retrospective, matched control group without immunonutrition. Early complication rates and the length of hospital stay were analyzed. The bilateral type I error was <0.05; the power was 90%. Thirty patients in each group were required. Thirty patients were included in each group, on a comparable basis. In the immunonutrition group, fewer postoperative complications (40 vs. 76.7%; p = 0.008), less paralytic ileus at D7 (6.6 vs. 33.3%; p = 0.02), fewer infections (23.3 vs. 60%; p = 0.008), and in particular less pyelonephritis (16.7 vs. 46.7%; p = 0.03) occurred. Clavien's grades for complications were higher in the control group (p = 0.04). Mortality, pulmonary embolism, anastomotic fistulae, and wound dehiscence were similar between two groups. The length of stay was reduced by 3 days in the immunonutrition group. In this pilot case-control study, immunonutrition is associated with a decrease in postoperative complications, urinary tract infections, Clavien's grade for complications, and paralytic ileus in patients undergoing cystectomy for bladder cancer. Prospective randomized placebo control studies are needed to confirm these promising results.

  2. Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study of the Effects of Vaginal Testosterone Therapy

    PubMed Central

    Dahir, Melissa; Travers-Gustafson, Dianne

    2014-01-01

    in women with breast cancer taking AIs. Dahir M and Travers-Gustafson D. Breast cancer, aromatase inhibitor therapy, and sexual functioning: A pilot study of the effects of vaginal testosterone therapy. Sex Med 2014;2:8–15. PMID:25356296

  3. Pilot Study of Massage to Improve Sleep and Fatigue in Hospitalized Adolescents With Cancer.

    PubMed

    Jacobs, Shana; Mowbray, Catriona; Cates, Lauren Muser; Baylor, Allison; Gable, Christopher; Skora, Elizabeth; Estrada, Monica; Cheng, Yao; Wang, Jichuan; Lewin, Daniel; Hinds, Pamela

    2016-05-01

    Adolescents with cancer experience many troubling symptoms, including sleep disruptions that can affect mood and quality of life. Massage is a safe and popular intervention that has demonstrated efficacy in pediatric and adult patients with cancer. This study aimed to assess the feasibility of conducting a massage intervention to help with sleep in hospitalized adolescent oncology patients. Adolescents ages 12-21 with cancer who were expected to be hospitalized for at least four consecutive nights were recruited from the inpatient unit at Children's National Health System and randomized to either massage intervention or a waitlist control. Patients in the intervention group received one massage per night, for two or three nights. Sleep was measured with actigraphy and patient and proxy reported instruments were used to measure fatigue, mood, and anxiety. The majority (78%) of patients approached for the study consented, and almost all patients in the intervention group (94%) received at least one massage, 69% received two, and rates of completion of instruments among adolescents were high demonstrating feasibility. There were trends toward increased night time and overall sleep in the intervention group compared with standard of care, but no differences between groups in the patient reported outcome measures. Participant and parent feedback on the intervention was positive and was the impetus for starting a clinical massage service at the hospital. Massage for hospitalized adolescents with cancer is feasible, well received, and can potentially improve patients' sleep. A randomized multicenter efficacy study is warranted. © 2016 Wiley Periodicals, Inc.

  4. Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single-blind controlled pilot study.

    PubMed

    Smykla, A; Walewicz, K; Trybulski, R; Halski, T; Kucharzewski, M; Kucio, C; Mikusek, W; Klakla, K; Taradaj, J

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  5. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  6. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study.

    PubMed

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy.

  7. Effect of Kinesiology Taping on Breast Cancer-Related Lymphedema: A Randomized Single-Blind Controlled Pilot Study

    PubMed Central

    Trybulski, R.; Kucharzewski, M.; Kucio, C.; Mikusek, W.; Klakla, K.

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785. PMID:24377096

  8. A Pilot Study of Proinflammatory Cytokines and Fatigue in Women With Breast Cancer During Chemotherapy.

    PubMed

    Raudonis, Barbara M; Kelley, Ingrid H; Rowe, Nancy; Ellis, Jenny

    Fatigue remains a prevalent, persistent, and debilitating side effect of chemotherapy for stage I and II breast cancer patients. Severity of fatigue varies among patients. Evidence suggests that proinflammatory cytokines contribute to the development of fatigue. The aim of this study is to investigate predictors of fatigue and cytokine levels in women undergoing chemotherapy for stage I or II breast cancer. Piper Fatigue Scales and blood samples for interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels were collected at baseline and days 7, 14, and 21 for each chemotherapy cycle. Descriptive statistics, general linear mixed models, and graphic analysis were used to analyze the data. The predominantly white convenience sample was composed of 11 women with stage I or II breast cancer who were 37 to 72 years old (mean, 52 years). Predictors of fatigue were type of chemotherapy drugs, time, and IL-6 levels. A predictor of IL-6 and TNF-α levels was whether chemotherapy was administered at the visit. Type of chemotherapy significantly predicted TNF-α levels. Fatigue patterns were characterized by chaotic pattern of peaks and troughs unique to each woman. Women with stage I and II breast cancer experienced variability in the severity of fatigue and levels of IL-6 and TNF-α throughout their treatment trajectories. The presence and role of genetic variants related to cancer-related fatigue may explain the individual variation and warrant further research. These findings highlight the importance of symptom assessments including fatigue at each clinic visit and individualized interventions throughout the cancer trajectory.

  9. Metabolic syndrome in Mexican women survivors of breast cancer: a pilot study at a general hospital.

    PubMed

    Ortiz-Mendoza, Carlos Manuel; de-la-Fuente-Vera, Tania Angélica; Pérez-Chávez, Ernesto

    2014-01-01

    According to developed countries' studies, in breast cancer survivors there is a high prevalence of metabolic syndrome; however, in Mexico data is lacking about this issue. To explore if metabolic syndrome occurs in Mexican women survivors of breast cancer. At a second-level general hospital, women with breast cancer with a surviving > 2 years were studied. The analysis involved their demographic and anthropometric features, blood pressure measurement, time of surviving, besides fasting blood levels of lipids and glucose. The sample consisted of 100 women; 42% were obese (body mass index > or = 30 kg/m2). The sample's mean age was 60 years with a mean surviving time of 6.5 years. Their mean glucose level was 122 mg/dL and triglycerides 202 mg/dL. There were 33% with blood pressure > or = 130/85mm Hg or diagnosis of hypertension. Fifty-seven percent had glucose > 99 mg/dL or diagnosis of diabetes mellitus, and 58% had triglycerides > 149 mg/dL. Metabolic syndrome occurred in 57% of obese women. Our results suggest that metabolic syndrome occurs in more than 50% of obese Mexican women survivors of breast cancer.

  10. Effectiveness of aroma massage on advanced cancer patients with constipation: a pilot study.

    PubMed

    Lai, T K T; Cheung, M C; Lo, C K; Ng, K L; Fung, Y H; Tong, M; Yau, C C

    2011-02-01

    The purpose of this study was to verify the effect of aroma massage on constipation in advanced cancer patients. This study employed a randomized control group pre- and post test design and included an aroma massage group, plain massage group, and control group. To evaluate the effect of aromatherapy, the degree of constipation was measured using a constipation assessment scale, severity level of constipation and the frequency of bowel movements. Data was analyzed by repeated measures of Mann-Whitney U test, Wilcoxon signed ranks test, Spearman's rho and ANOVA using SPSS program. The score of the constipation assessment scale of the aroma massage group was significantly lower than the control group. Apart from the improvement in bowel movements, the results showed significantly improved quality of life in physical and support domains of the aroma massage group. The findings of this study suggest aroma massage can help to relieve constipation in patients with advanced cancer. Copyright © 2010 Elsevier Ltd. All rights reserved.

  11. How to select elderly colorectal cancer patients for surgery: a pilot study in an Italian academic medical center

    PubMed Central

    Ugolini, Giampaolo; Pasini, Francesco; Ghignone, Federico; Zattoni, Davide; Bacchi Reggiani, Maria Letizia; Parlanti, Daniele; Montroni, Isacco

    2015-01-01

    Objective Cancer is one of the most common diagnoses in elderly patients. Of all types of abdominal cancer, colorectal cancer (CRC) is undoubtedly the most frequent. Median age at diagnosis is approximately 70 years old worldwide. Due to the multiple comorbidities affecting elderly people, frailty evaluation is very important in order to avoid over- or under-treatment. This pilot study was designed to investigate the variables capable of predicting the long-term risk of mortality and living situation after surgery for CRC. Methods Patients with 70 years old and older undergoing elective surgery for CRC were prospectively enrolled in the study. The patients were preoperatively screened using 11 internationally-validated-frailty-assessment tests. The endpoints of the study were long-term mortality and living situation. The data were analyzed using univariate Cox proportional-hazard regression analysis to verify the predictive value of score indices in order to identify possible risk factors. Results Forty-six patients were studied. The median follow-up time after surgery was 4.6 years (range, 2.9-5.7 years) and no patients were lost to follow-up. The overall mortality rate was 39%. Four of the patients who survived (4/28, 14%) lost their functional autonomy. The preoperative impaired Timed Up and Go (TUG), Eastern Cooperative Group Performance Status (ECOG PS), Instrumental Activities of Daily Living (IADLs), Vulnerable Elders Survey (VES-13) scoring systems were significantly associated with increased long term mortality risk. Conclusion Simplified frailty-assessing tools should be routinely used in elderly cancer patients before treatment in order to stratify patient risk. The TUG, ECOG-PS, IADLs and VES-13 scoring systems are potentially able to predict long-term mortality and disability. Additional studies will be needed to confirm the preliminary data in order to improve management strategies for oncogeriatric surgical patients. PMID:26779367

  12. A randomised controlled pilot feasibility study of the physical and psychological effects of an integrated support programme in breast cancer.

    PubMed

    Baker, Barbara S; Harrington, Julia E; Choi, Beak-San; Kropf, Pascale; Muller, Ingrid; Hoffman, Caroline J

    2012-08-01

    A pilot study was conducted to assess recruitment and effectiveness of an integrated support programme in women with breast cancer. Twelve participants were randomised to receive medical care with or without the support programme. Psychosocial questionnaires and immune/hormonal assays were completed at baseline, three and six months. Recruitment was problematic. In the intervention group, mental fatigue was significantly improved (p = 0.016) compared to controls; increased NK cell activity suggested an improvement in immune function. Total stress (p = 0.009), anxiety (p = 0.032) and endocrine-specific (p = 0.032) symptoms were significantly improved in the controls. A large-scale randomisation trial appears warranted, dependent upon effective recruitment.

  13. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer.

    PubMed

    Grob, Charles S; Danforth, Alicia L; Chopra, Gurpreet S; Hagerty, Marycie; McKay, Charles R; Halberstadt, Adam L; Greer, George R

    2011-01-01

    Researchers conducted extensive investigations of hallucinogens in the 1950s and 1960s. By the early 1970s, however, political and cultural pressures forced the cessation of all projects. This investigation reexamines a potentially promising clinical application of hallucinogens in the treatment of anxiety reactive to advanced-stage cancer. To explore the safety and efficacy of psilocybin in patients with advanced-stage cancer and reactive anxiety. A double-blind, placebo-controlled study of patients with advanced-stage cancer and anxiety, with subjects acting as their own control, using a moderate dose (0.2 mg/kg) of psilocybin. A clinical research unit within a large public sector academic medical center. Twelve adults with advanced-stage cancer and anxiety. In addition to monitoring safety and subjective experience before and during experimental treatment sessions, follow-up data including results from the Beck Depression Inventory, Profile of Mood States, and State-Trait Anxiety Inventory were collected unblinded for 6 months after treatment. Safe physiological and psychological responses were documented during treatment sessions. There were no clinically significant adverse events with psilocybin. The State-Trait Anxiety Inventory trait anxiety subscale demonstrated a significant reduction in anxiety at 1 and 3 months after treatment. The Beck Depression Inventory revealed an improvement of mood that reached significance at 6 months; the Profile of Mood States identified mood improvement after treatment with psilocybin that approached but did not reach significance. This study established the feasibility and safety of administering moderate doses of psilocybin to patients with advanced-stage cancer and anxiety. Some of the data revealed a positive trend toward improved mood and anxiety. These results support the need for more research in this long-neglected field. clinicaltrials.gov Identifier: NCT00302744.

  14. The use of molecular breast imaging to assess response in women undergoing neoadjuvant therapy for breast cancer: a pilot study.

    PubMed

    Wahner-Roedler, Dietlind L; Boughey, Judy C; Hruska, Carrie B; Chen, Beiyun; Rhodes, Deborah J; Tortorelli, Cindy L; Maxwell, Robert W; Cha, Stephen S; O'Connor, Michael K

    2012-04-01

    To report our findings from a prospective pilot study evaluating the accuracy of molecular breast imaging (MBI) in assessing tumor response to neoadjuvant therapy (NT) for breast cancer. Twenty patients with newly diagnosed invasive breast cancer who were scheduled to receive NT underwent MBI before beginning and after completing NT before surgery. MBI was performed using a dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry after patients had received an intravenous injection of 20 mCi of 99mTc sestamibi. Tumor extent was measured on MBI, and tumor-to-background (T/B) ratios of radiotracer uptake were determined through region-of-interest analysis. Pathologic measurement of tumor size was used as a standard and compared with post-NT tumor size derived from MBI. Three patients in whom post-NT MBI could not be performed because of scheduling problems were excluded from analysis. Eighteen cancers were diagnosed in 17 patients. A correlation coefficient of r = 0.681 (P = 0.002) was found between MBI and residual tumor size. The average T/B ratio on MBI decreased from a pretreatment value of 3.0 to a posttreatment value of 1.4. The relative decrease in T/B ratio did not appear to be predictive of response. Measurements of tumor size by MBI and T/B ratios are limited in their predictive value regarding the pathologic extent of residual disease in women treated with NT for breast cancer. Alternate tumor-specific radiopharmaceuticals should be evaluated to provide information to improve planning and monitoring of breast cancer treatment.

  15. Association between Chemotherapy-Response Assays and Subsets of Tumor-Infiltrating Lymphocytes in Gastric Cancer: A Pilot Study

    PubMed Central

    Lee, Jee Youn; Son, Taeil; Cheong, Jae-Ho; Hyung, Woo Jin; Noh, Sung Hoon; Kim, Choong-Bai; Park, Chung-Gyu

    2015-01-01

    Purpose The purpose of this pilot study was to evaluate the association between adenosine triphosphate-based chemotherapy response assays (ATP-CRAs) and subsets of tumor infiltrating lymphocytes (TILs) in gastric cancer. Materials and Methods In total, 15 gastric cancer tissue samples were obtained from gastrectomies performed between February 2007 and January 2011. Chemotherapy response assays were performed on tumor cells from these samples using 11 chemotherapeutic agents, including etoposide, doxorubicin, epirubicin, mitomycin, 5-fluorouracil (5-FU), oxaliplatin, irinotecan, docetaxel, paclitaxel, methotrexate, and cisplatin. TILs in the tissue samples were evaluated using antibodies specific for CD3, CD4, CD8, Foxp3, and Granzyme B. Results The highest cancer cell death rates were induced by etoposide (44.8%), 5-FU (43.1%), and mitomycin (39.9%). Samples from 10 patients who were treated with 5-FU were divided into 5-FU-sensitive and -insensitive groups according to median cell death rate. No difference was observed in survival between the two groups (P=0.216). Only two patients were treated with a chemotherapeutic agent determined by an ATP-CRA and there was no significant difference in overall survival compared with that of patients treated with their physician's choice of chemotherapeutic agent (P=0.105). However, a high number of CD3 TILs was a favorable prognostic factor (P=0.008). Pearson's correlation analyses showed no association between cancer cell death rates in response to chemotherapeutic agents and subsets of TILs. Conclusions Cancer cell death rates in response to specific chemotherapeutic agents were not significantly associated with the distribution of TIL subsets. PMID:26819801

  16. Improvement of QOL and Immunological Function With Lentinula Edodes Mycelia in Patients Undergoing Cancer Immunotherapy: An Open Pilot Study.

    PubMed

    Tanigawa, Keishi; Itoh, Yusuke; Kobayashi, Yasunobu

    2016-07-01

    Context • Combined treatment with an extract of Lentinula edodes mycelia (LEM) and chemotherapy has been reported to improve quality of life (QOL) and immunological function in cancer patients. However, those effects have not been elucidated for patients receiving cancer immunotherapy. Objective • The present study intended to investigate the effects of oral LEM on QOL and immunological function in cancer patients receiving immunotherapy. Design • The research team designed an open-label, single-armed pilot study. Setting • The study took place at Bio-Thera Clinic, a facility associated with Tokyo Women's Medical University in Tokyo, Japan. Participants • The participants were 10 cancer patients undergoing cancer immunotherapy at Bio-Thera Clinic. Intervention • The participants received either dendritic cell (DC)-based cancer vaccine therapy or CD3-activated T-lymphocyte (CAT) therapy as immunotherapy. They received the immunotherapy only for the first 4 wk of the study, and then oral LEM (1800 mg/d) was added for the next 4 wk. Outcome Measures • Preintervention and at 4 and 8 wk after the start of the study, participants completed a QOL survey, and immunological parameters were measured. Results • Participants' QOL symptom scores increased (ie, worsened) by 5.1 ± 1.7 during the first 4 wk of treatment when they were receiving immunotherapy only, but it decreased (ie, improved) by -2.5 ± 1.6 during the next 4 wk when the immunotherapy was combined with the LEM, P < .05. The measurement of the immunological parameters during the 4 wk of immunotherapy combined with LEM showed that the amount of interferon-γ (IFN-γ) produced in the peripheral blood tended to increase as compared with that during the first 4 wk of immunotherapy only. The rise in IFN-γ was correlated with changes in several regulatory T cells (Tregs) (ie, forkhead box P3 [FOXP3]+/cluster of differentiation 4 [CD4]+ and transforming growth factor beta [TGF-β]). Conclusions • The

  17. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m[sup 3]) of tertiary oil have been recovered. Microbial activity has increased CO[sub 2] content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  18. What Impact Do Chaplains Have? A Pilot Study of Spiritual AIM for Advanced Cancer Patients in Outpatient Palliative Care.

    PubMed

    Kestenbaum, Allison; Shields, Michele; James, Jennifer; Hocker, Will; Morgan, Stefana; Karve, Shweta; Rabow, Michael W; Dunn, Laura B

    2017-07-20

    Spiritual care is integral to quality palliative care. Although chaplains are uniquely trained to provide spiritual care, studies evaluating chaplains' work in palliative care are scarce. The goals of this pre-post study, conducted among patients with advanced cancer receiving outpatient palliative care, were to evaluate the feasibility and acceptability of chaplain-delivered spiritual care, utilizing the Spiritual Assessment and Intervention Model ("Spiritual AIM"); and to gather pilot data on Spiritual AIM's effects on spiritual well-being, religious and cancer-specific coping, and physical and psychological symptoms. Patients with advanced cancer (n=31) who were receiving outpatient palliative care were assigned based on chaplains' and patients' outpatient schedules, to one of three professional chaplains for three individual Spiritual AIM sessions, conducted over the course of approximately six to eight weeks. Patients completed the following measures at baseline and post-intervention: Edmonton Symptom Assessment Scale (ESAS), Steinhauser spirituality, Brief Religious Coping (Brief RCOPE), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp-12), Mini-Mental Adjustment to Cancer (Mini-MAC), Patient Dignity Inventory, Center for Epidemiological Studies - Depression (CES-D, 10-item), and Spielberger State Anxiety Inventory (STAI-S). From baseline to post-Spiritual AIM, significant increases were found on the FACIT-Sp-12 Faith subscale, the Mini-MAC Fighting Spirit subscale, and Mini-MAC Adaptive Coping factor. Two trends were observed, i.e., an increase in Positive religious coping and an increase in Fatalism (a subscale of the Mini-MAC). Spiritual AIM, a brief chaplain-led intervention, holds potential to address spiritual needs, as well as religious and general coping in patients with serious illnesses. Copyright © 2017. Published by Elsevier Inc.

  19. Single high dose intraoperative electrons for advanced stage pancreatic cancer: Phase I pilot study

    SciTech Connect

    Goldson, A.L.; Ashaveri, E.; Espinoza, M.C.

    1981-07-01

    Phase I toxicity studies with intraoperative radiotherapy proved to be a feasible adjunct to surgery for unresectable malignancies of the pancreas at Howard University Hospital. There have been minimal side effects or complications related to the combination of limited surgical decompression and intraoperative radiotherapy alone. The toxic effects of intraoperative radiotherapy on normal tissues is being assessed on a dose volume basis. Doses of 2000 to 2500 rad in a single exposure to include the pancreas, regional nodes and duodenum are acceptable if the total treatment volume is less than or equal to 100 cm. The tumoricidal effects on the cancer are demonstratable when one reviews the pathological specimens that illustrate massive tumor necrosis and fibros replacement, but in all cases reviewed, viable cancer was noted. Intraoperative radiotherapy, therefore, represents a significant boost dose for resectable, partially resectable or non-resectable tumors when added to conventional external beam irradiation and/or chemotherapy. Preliminary clinical data and minimal toxicity justifies further investigation.

  20. A pilot study on the role of fractal analysis in the microscopic evaluation of colorectal cancers.

    PubMed

    Streba, Liliana; ForŢofoiu, Mircea Cătălin; Popa, Carmen; Ciobanu, Daniela; Gruia, Corina Lavinia; Mogoantă, Stelian ŞtefăniŢă; Streba, Costin Teodor

    2015-01-01

    Colorectal cancer (CRC) represents one of the most common cancers worldwide; its growing incidence and prevalence quickly transforming it into a major health burden. Globally, survival varies from one country to another and constantly remains significantly low, despite increasing diagnostic efforts and tools. Fractal geometry and, specifically, fractal dimension (FD) are interesting tools to quantify cellular elements. In this paper, we aimed to identify and quantify by fractal analysis the elements obtained from medical images from pathological and immunohistochemical investigations of colonic biopsy fragments. We prospectively selected the study group between September 2014 and January 2015, from patients who underwent surgery for previously diagnosed CRC at the Emergency County Hospital, Craiova, Romania. We performed the histological and immunohistochemical studies by following standardized protocols. Anti-Ki67, anti-p53 and anti-VEGF-C antibodies were used for immunostaining. We performed the fractal analysis with an in-house tool and we performed statistical tests on the results. We have included 41 (29 males) consecutive patients with different characteristics; after analyzing the FDs we found significant differences between adenocarcinomas and the other types of colonic cancers (p<0.001). However, we found no significant differences between most types of CRCs. We found significant statistical differences when compared well-differentiated tumors with all other stages (p<0.001). Fractal analysis with the calculation of FDs is a novel, interesting tool, for determining the pathologic diagnosis of CRCs and may further improve diagnostic and prognostic rates, thus improving patient care.

  1. Photoacoustic spectroscopy based investigatory approach to discriminate breast cancer from normal: a pilot study

    NASA Astrophysics Data System (ADS)

    Priya, Mallika; Rao, Bola Sadashiva Satish; Chandra, Subhash; Ray, Satadru; Mathew, Stanley; Datta, Anirbit; Nayak, Subramanya G.; Mahato, Krishna Kishore

    2016-02-01

    In spite of many efforts for early detection of breast cancer, there is still lack of technology for immediate implementation. In the present study, the potential photoacoustic spectroscopy was evaluated in discriminating breast cancer from normal, involving blood serum samples seeking early detection. Three photoacoustic spectra in time domain were recorded from each of 20 normal and 20 malignant samples at 281nm pulsed laser excitations and a total of 120 spectra were generated. The time domain spectra were then Fast Fourier Transformed into frequency domain and 116.5625 - 206.875 kHz region was selected for further analysis using a combinational approach of wavelet, PCA and logistic regression. Initially, wavelet analysis was performed on the FFT data and seven features (mean, median, area under the curve, variance, standard deviation, skewness and kurtosis) from each were extracted. PCA was then performed on the feature matrix (7x120) for discriminating malignant samples from the normal by plotting a decision boundary using logistic regression analysis. The unsupervised mode of classification used in the present study yielded specificity and sensitivity values of 100% in each respectively with a ROC - AUC value of 1. The results obtained have clearly demonstrated the capability of photoacoustic spectroscopy in discriminating cancer from the normal, suggesting its possible clinical implications.

  2. Use of 99mTc-doxorubicin scintigraphy in females with breast cancer: a pilot study

    PubMed Central

    Araujo, F I; Proença, F P P; Ferreira, C G; Ventilari, S C; Rosado de Castro, P H; Moreira, R D; Fonseca, L M B; Gutfilen, B

    2015-01-01

    Objective: Doxorubicin (Eurofarma, São Paulo, Brazil) is an antitumour agent widely used in the treatment of breast cancer and can be used for tumour tracking when labelled with a radionuclide. Here, we present the results obtained with technetium-99m (99mTc)-doxorubicin, using the direct method, to evaluate its uptake in breast cancer. Methods: Four females with confirmed breast carcinoma diagnosis and breast image reporting and data system Category 5 on mammography underwent whole-body and thorax single-photon emission CT/CT imaging 1 and 3 h after 99mTc-doxorubicin administration. Results: We observed increased uptake in breast carcinoma lesions and elimination via renal and hepatic pathways. Conclusion: These preliminary results suggest that 99mTc-doxorubicin may be a promising radiopharmaceutical for the evaluation of patients with breast cancer. Further studies are ongoing. Advances in knowledge: To our knowledge, this is the first study to evaluate the use of a directly labelled doxorubicin tracer in humans. 99mTc-doxorubicin could provide information on the response of tumours to doxorubicin. PMID:26111270

  3. Green Tea Improves Metabolic Biomarkers, not Weight or Body Composition: A Pilot Study in Overweight Breast Cancer Survivors

    PubMed Central

    Stendell-Hollis, Nicole R; Thomson, Cynthia A; Thompson, Patricia A; Bea, Jennifer W; Cussler, Ellen C; Hakim, Iman A

    2010-01-01

    Background Overweight status after breast cancer treatment may increase a woman’s risk for recurrent disease and/or early onset cardiovascular disease. Green tea has been proposed to promote weight loss and favourably modify glucose, insulin and blood lipids. This pilot study tested the effect of daily decaffeinated green tea consumption for 6 months on weight and body composition, select metabolic parameters, and lipid profiles in overweight breast cancer survivors. Methods The effect of daily decaffeinated green tea intake on weight, body composition and changes in resting metabolic rate, energy intake, glucose, insulin, HOMA-IR, and lipids was evaluated in overweight breast cancer survivors. Participants had a mean weight of 80.2 kg; BMI 30.1 kg/m2; and body fat 46.4%. Participants (N=54) were randomised to 960 mL decaffeinated green or placebo tea daily for 6 months. Results Average tea intake among study completers (N=39) was 5952 ± 1176 mL/week and was associated with a significant reduction in energy intake (P =0.02). Change in body weight of −1.2 kg (green tea) versus + 0.2 kg (placebo) suggests a weight change effect, but was not statistically significant. Decaffeinated green tea intake was associated with elevated HDL levels (P=0.003) and non-significant improvements in the HOMA-IR (−1.1±5.9: green tea; +3.2±7.2: herbal) and the HDL/LDL ratio. Conclusions Intake of decaffeinated green tea for 6 months was associated with a slight reduction in body weight and improved HDL and glucose homeostasis in overweight breast cancer survivors. PMID:20807303

  4. Green tea improves metabolic biomarkers, not weight or body composition: a pilot study in overweight breast cancer survivors.

    PubMed

    Stendell-Hollis, N R; Thomson, C A; Thompson, P A; Bea, J W; Cussler, E C; Hakim, I A

    2010-12-01

    Overweight status after breast cancer treatment may increase a woman's risk for recurrent disease and/or early onset cardiovascular disease. Green tea has been proposed to promote weight loss and favourably modify glucose, insulin and blood lipids. This pilot study tested the effect of daily decaffeinated green tea consumption for 6 months on weight and body composition, select metabolic parameters and lipid profiles in overweight breast cancer survivors. The effect of daily decaffeinated green tea intake on weight, body composition and changes in resting metabolic rate, energy intake, glucose, insulin, homeostasis model assessment--insulin resistance (HOMA-IR) and lipids was evaluated in overweight breast cancer survivors. Participants had a mean weight of 80.2 kg; body mass index (BMI) 30.1 kg m⁻²; and body fat 46.4%. Participants (n = 54) were randomised to 960 mL of decaffeinated green or placebo tea daily for 6 months. Mean (SD) tea intake among study completers (n = 39) was 5952 (1176) mL week⁻¹ and was associated with a significant reduction in energy intake (P = 0.02). Change in body weight of -1.2 kg (green tea) versus +0.2 kg (placebo) suggests a weight change effect, although this was not statistically significant. Decaffeinated green tea intake was associated with elevated high-density lipoprotein (HDL) levels (P = 0.003) and nonsignificant improvements in the HDL/LDL ratio and HOMA-IR (-1.1 ± 5.9: green tea; +3.2 ± 7.2: herbal). Intake of decaffeinated green tea for 6 months was associated with a slight reduction in body weight and improved HDL and glucose homeostasis in overweight breast cancer survivors. © 2010 The Authors. Journal compilation © 2010 The British Dietetic Association Ltd.

  5. A pilot study evaluating genetic alterations that drive tobacco- and betel quid-associated oral cancer in Northeast India.

    PubMed

    Yadav, Dhirendra Singh; Chattopadhyay, Indranil; Verma, Anand; Devi, Thoudam Regina; Singh, L C; Sharma, Jagannath Dev; Kataki, Amal Ch; Saxena, Sunita; Kapur, Sujala

    2014-09-01

    The susceptibility of an individual to oral cancer is mediated by genetic factors and carcinogen-exposure behaviors such as betel quid chewing, tobacco use, and alcohol consumption. This pilot study was aimed to identify the genetic alteration in 100 bp upstream and downstream flanking regions in addition to the exonic regions of 169 cancer-associated genes by using Next Generation sequencing with aim to elucidate the molecular pathogenesis of tobacco- and betel quid-associated oral cancer of Northeast India. To understand the role of chemical compounds present in tobacco and betel quid associated with the progression of oral cancer, single nucleotide polymorphisms (SNPs) and insertion and deletion (Indels) found in this study were analyzed for their association with chemical compounds found in tobacco and betel quid using Comparative Toxogenomic Database. Genes (AR, BRCA1, IL8, and TP53) with novel SNP were found to be associated with arecoline which is the major component of areca nut. Genes (BARD1, BRCA2, CCND2, IGF1R, MSH6, and RASSF1) with novel deletion and genes (APC, BRMS1, CDK2AP1, CDKN2B, GAS1, IGF1R, and RB1) with novel insertion were found to be associated with aflatoxin B1 which is produced by fermented areca nut. Genes (ADH6, APC, AR, BARD1, BRMS1, CDKN1A, E2F1, FGFR4, FLNC, HRAS, IGF1R, IL12B, IL8, NBL1, STAT5B, and TP53) with novel SNP were found to be associated with aflatoxin B1. Genes (ATM, BRCA1, CDKN1A, EGFR, IL8, and TP53) with novel SNP were found to be associated with tobacco specific nitrosamines.

  6. Label-free reflectance hyperspectral imaging for tumor margin assessment: a pilot study on surgical specimens of cancer patients

    NASA Astrophysics Data System (ADS)

    Fei, Baowei; Lu, Guolan; Wang, Xu; Zhang, Hongzheng; Little, James V.; Patel, Mihir R.; Griffith, Christopher C.; El-Diery, Mark W.; Chen, Amy Y.

    2017-08-01

    A label-free, hyperspectral imaging (HSI) approach has been proposed for tumor margin assessment. HSI data, i.e., hypercube (x,y,λ), consist of a series of high-resolution images of the same field of view that are acquired at different wavelengths. Every pixel on an HSI image has an optical spectrum. In this pilot clinical study, a pipeline of a machine-learning-based quantification method for HSI data was implemented and evaluated in patient specimens. Spectral features from HSI data were used for the classification of cancer and normal tissue. Surgical tissue specimens were collected from 16 human patients who underwent head and neck (H&N) cancer surgery. HSI, autofluorescence images, and fluorescence images with 2-deoxy-2-[(7-nitro-2,1,3-benzoxadiazol-4-yl)amino]-D-glucose (2-NBDG) and proflavine were acquired from each specimen. Digitized histologic slides were examined by an H&N pathologist. The HSI and classification method were able to distinguish between cancer and normal tissue from the oral cavity with an average accuracy of 90%±8%, sensitivity of 89%±9%, and specificity of 91%±6%. For tissue specimens from the thyroid, the method achieved an average accuracy of 94%±6%, sensitivity of 94%±6%, and specificity of 95%±6%. HSI outperformed autofluorescence imaging or fluorescence imaging with vital dye (2-NBDG or proflavine). This study demonstrated the feasibility of label-free, HSI for tumor margin assessment in surgical tissue specimens of H&N cancer patients. Further development of the HSI technology is warranted for its application in image-guided surgery.

  7. The Pilot Training Study: Personnel Flow and the PILOT Model.

    ERIC Educational Resources Information Center

    Mooz, W. E.

    The results of the Rand study of pilot flows and the computer-operated decision model, called the PILOT model, are described. The flows of pilots within the Air Force are caused by policies that require the career-development rotation of pilots from cockpit jobs to desk jobs, the maintenance of a supplement of pilots in excess of cockpit-related…

  8. Chemotherapy Altered Brain Functional Connectivity in Women with Breast Cancer: A Pilot Study

    PubMed Central

    Dumas, Julie A.; Makarewicz, Jenna; Schaubhut, Geoffrey J.; Devins, Robert; Albert, Kimberly; Dittus, Kim; Newhouse, Paul A.

    2013-01-01

    Adjuvant chemotherapy is associated with improvements in long-term cancer survival. However, reports of cognitive impairment following treatment emphasize the importance of understanding the long-term effects of chemotherapy on brain functioning. Cognitive deficits found in chemotherapy patients suggest a change in brain functioning that affects specific cognitive domains such as attentional processing and executive functioning. This study examined the processes potentially underlying these changes in cognition by examining brain functional connectivity pre- and post-chemotherapy in women with breast cancer. Functional connectivity examines the temporal correlation between spatially remote brain regions in an effort to understand how brain networks support specific cognitive functions. Nine women diagnosed with breast cancer completed a functional magnetic resonance imaging (fMRI) session before chemotherapy, one month after, and one year after the completion of chemotherapy. Seed-based functional connectivity analyses were completed using seeds in the intraparietal sulcus (IPS) to examine connectivity in the dorsal anterior attention network and in the posterior cingulate cortex (PCC) to examine connectivity in the default mode network. Results showed decreased functional connectivity one month after chemotherapy that partially returned to baseline at one year in the dorsal attention network. Decreased connectivity was seen in the default mode network at one month and one year following chemotherapy. In addition, increased subjective memory complaints were noted at one month and one year post-chemotherapy. These findings suggest a detrimental effect of chemotherapy on brain functional connectivity that is potentially related to subjective cognitive assessment. PMID:23852814

  9. Healthcare Providers' Perceptions of the Utility of Psychosocial Screening Tools in Childhood Cancer: A Pilot Study.

    PubMed

    Di Battista, Ashley; Hancock, Kelly; Cataudella, Danielle; Johnston, Donna; Cassidy, Marilyn; Punnett, Angela; Shama, Wendy; Barrera, Maru

    2015-07-01

    To examine the perceptions of healthcare providers (HCPs) regarding the utility of two psychosocial screening tools designed for pediatric oncology, the Psychosocial Assessment Tool-Revised (PATrev) and the Psychosocial Care Checklist (PCCL). Repeated measures comparative study. Four pediatric health centers in Ontario, Canada. 15 oncologists, 14 nurses, and 8 social workers. Using a visual analog scale (VAS), participants were asked to rate how useful they found (a) the psychosocial summary derived from the parent-completed PATrev, used to assess family psychosocial risk, and (b) the HCP-completed PCCL, used to identify family psychosocial needs. Measures were completed soon after diagnosis and six months later. Mann-Whitney U tests were used for analyses. VAS scores. Pediatric oncology HCPs differ in their acceptance of the psychosocial screening tools tested. The highest utility ratings for both instruments were from nurses, and the lowest utility ratings were from social workers; moderate ratings were obtained from oncologists. Psychosocial screening tools can identify the psychosocial needs of children with cancer and their families throughout the cancer trajectory. Consequently, these tools could foster communication among colleagues (medical and nonmedical) who are caring for children with cancer about the psychosocial needs of this population and the allocation of resources to address those needs. Nurses seem to value these tools more than other HCPs, which may have positive implications for their clinical practice.

  10. A pilot study of lymph node mapping with indocyanine green in robotic gastrectomy for gastric cancer.

    PubMed

    Lan, Yuan-Tzu; Huang, Kuo-Hung; Chen, Ping-Hsien; Liu, Chien-An; Lo, Su-Shun; Wu, Chew-Wun; Shyr, Yi-Ming; Fang, Wen-Liang

    2017-01-01

    Robotic gastrectomy has become increasingly popular in the treatment of gastric cancer, especially in Asian countries. The use of indocyanine green fluorescence has been reported in lymphatic mapping for gastric cancer in laparoscopic gastrectomy; however, there have been few reports regarding the use of indocyanine green in robotic gastrectomy. From January 2011 to March 2016, a total of 79 patients underwent robotic gastrectomy for gastric cancer. Among them, intraoperative subserosal injection (n = 9) or preoperative submucosal injection (n = 5) of indocyanine green with near-infrared imaging was performed in 14 patients, and the other 65 patients underwent robotic gastrectomy without the use of indocyanine green. There was no significant difference in the operative time, total number of retrieved lymph nodes, operative blood loss, and postoperative hospital stay between the patients who underwent robotic gastrectomy with or without indocyanine green fluorescence. For each lymph node station, there was significantly more number of retrieved lymph nodes in the indocyanine green group than in the no-indocyanine green group at the greater curvature side of the low body (#4d) to the infrapyloric region (#6) of the stomach. Five of the 14 patients who received an indocyanine green injection for lymphatic mapping had lymph node metastasis, and metastatic lymph nodes were located in the lymph node stations as detected by indocyanine green fluorescence during surgery. Indocyanine green fluorescence with near-infrared imaging is feasible and is a promising method of lymphatic mapping in robotic gastrectomy for gastric cancer. In future studies, larger patient numbers and long-term follow-up are required.

  11. Inter-observer variability in the classification of ovarian cancer cell type using microscopy: a pilot study

    NASA Astrophysics Data System (ADS)

    Gavrielides, Marios A.; Ronnett, Brigitte M.; Vang, Russell; Seidman, Jeffrey D.

    2015-03-01

    Studies have shown that different cell types of ovarian carcinoma have different molecular profiles, exhibit different behavior, and that patients could benefit from typespecific treatment. Different cell types display different histopathology features, and different criteria are used for each cell type classification. Inter-observer variability for the task of classifying ovarian cancer cell types is an under-examined area of research. This study served as a pilot study to quantify observer variability related to the classification of ovarian cancer cell types and to extract valuable data for designing a validation study of digital pathology (DP) for this task. Three observers with expertise in gynecologic pathology reviewed 114 cases of ovarian cancer with optical microscopy, with specific guidelines for classifications into distinct cell types. For 93 cases all 3 pathologists agreed on the same cell type, for 18 cases 2 out of 3 agreed, and for 3 cases there was no agreement. Across cell types with a minimum sample size of 10 cases, agreement between all three observers was {91.1%, 80.0%, 90.0%, 78.6%, 100.0%, 61.5%} for the high grade serous carcinoma, low grade serous carcinoma, endometrioid, mucinous, clear cell, and carcinosarcoma cell types respectively. These results indicate that unanimous agreement varied over a fairly wide range. However, additional research is needed to determine the importance of these differences in comparison studies. These results will be used to aid in the design and sizing of such a study comparing optical and digital pathology. In addition, the results will help in understanding the potential role computer-aided diagnosis has in helping to improve the agreement of pathologists for this task.

  12. HPV-16 variants' impact on uterine cervical cancer response to radiotherapy: A descriptive pilot study.

    PubMed

    Moreno-Acosta, P; Vallard, A; Molano, M; Huertas, A; Gamboa, Ó; Cotes, M; Romero-Rojas, A; Rancoule, C; Magné, N

    2017-04-01

    Although the large impact of Human papilloma virus (HPV) in cervical cancer is established, its place as a therapeutic target is new and according to the growing literature, could be promising. In the present study, radiosensitivity's difference based on HPV-16 variants is assessed. Variants of Human papilloma virus were identified before the exclusive radiotherapy in patients with cervical cancer. Data were prospectively collected. Fifty-nine patients were screened. Among the 59 screened patients, 34 (57.6%) were identified to be HPV-16 (+), with 13 European and two non-European variants. Of the 34 patients, 15 experienced exclusive radiotherapy. Among them, eight had complete response (seven with European and one with non-European variants), four with European variant had partial response, three with European variant had tumour persistence and one with non-European variant progressed at 3 months. No radiosensitivity difference was established, probably because of the limited population. Non-European variant aggressiveness might be suggested in accordance with the literature, as it was associated with the only tumour progression. Exclusive radiotherapy provides a unique and "pure" model of radioresistance in cervical cancer and could be the missing link between in vitro studies and state of the art chemoradiotherapy studies that probably feature too many parameters to identify radioresistance causes. The present study was a first step, with the future prospects of building a larger cohort study in order to better understand HPV-induced radioresistance and then to be able to propose new made-to-measure treatments. Copyright © 2017 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

  13. The Effect of Prospective Monitoring and Early Physiotherapy Intervention on Arm Morbidity Following Surgery for Breast Cancer: A Pilot Study

    PubMed Central

    Singh, Chiara; De Vera, Mary

    2013-01-01

    ABSTRACT Purpose: Significant arm morbidity is reported following surgery for breast cancer, yet physiotherapy is not commonly part of usual care. This study compared the effect on arm morbidity after surgery for breast cancer of a clinical care pathway including preoperative education, prospective monitoring, and early physiotherapy (experimental group) to that of preoperative education alone (comparison group). Methods: A prospective quasi-experimental pretest–posttest, non-equivalent group design compared two clinical sites; Site A (n=41) received the experimental intervention, and Site B (n=31) received the comparison intervention. At baseline (preoperative) and 7 months postoperative, shoulder range of motion (ROM), upper-extremity (UE) strength, UE circumference, pain, UE function, and quality of life were assessed. Results: The experimental group maintained shoulder flexion ROM at 7 months, whereas the comparison group saw a decrease (mean 1° [SD 9°] vs. −6° [SD 15°], p=0.03). A lower incidence of arm morbidity and better quality of life were observed in the experimental group, but these findings were not statistically significant. Baseline characteristics and surgical approaches differed between the two sites, which may have had an impact on the findings. Conclusion: Initial results are promising and support the feasibility of integrating a surveillance approach into follow-up care. This pilot study provides the foundation for a larger, more definitive trial. PMID:24403683

  14. A Pilot Study on Tamoxifen Sexual Side Effects and Hand Preference in Male Breast Cancer.

    PubMed

    Motofei, Ion G; Rowland, David L; Popa, Florian; Bratucu, Eugen; Straja, Dan; Manea, Mirela; Georgescu, Simona R; Paunica, Stana; Bratucu, Mircea; Balalau, Cristian; Constantin, Vlad D

    2015-08-01

    Recent clinical and imaging studies suggest that sex hormones modulate sexuality according to a psychophysiologic process of lateralization of the brain, with androgens playing a greater role in sexual functioning of left hemibrain/right handedness and estrogens possibly for right hemibrain/left handedness. Based on this perspective, the current study attempted to specify the relationship between hand preference, estrogens, and sexual function in subjects with male breast cancer, taking into account the sexual side effects of tamoxifen as the agent for inhibiting estrogen action. Twenty-eight Romanian men-17 right-handed and 11 left-handed-undergoing treatment with tamoxifen for male breast cancer participated in this study. These men were assessed both prior to and during tamoxifen treatment using the International Index of Erectile Function, a standardized instrument used for the evaluation of various aspects of sexual functioning, including erectile function (EF), orgasmic function (OF), sexual desire (SD), and overall functioning (OF). A main effect for handedness was found on EF, OF, SD, and OS scales, with right-handed men showing higher functioning than left-handed men. Regarding interaction effects, the left-handed group of men showed greater decreased sexual functioning during tamoxifen (on three subscales: OF, SD, OS) compared to right-handed men. Further research should be conducted in order to support and refine this potential lateralized process of sexual neuromodulation within the brain.

  15. A pilot study examining germline minisatellite mutations in the offspring of Danish childhood and adolescent cancer survivors treated with radiotherapy

    PubMed Central

    REES, GWEN S.; TRIKIC, MICHAEL Z.; WINTHER, JEANETTE F.; TAWN, E. JANET; STOVALL, MARILYN; OLSEN, JØRGEN H.; RECHNITZER, CATHERINE; SCHRØDER, HENRIK; GULDBERG, PER; BOICE, JOHN D.

    2009-01-01

    Purpose To investigate germline mutation rate at eight minisatellite loci in 24 Danish families, where one parent is the survivor of childhood or adolescent cancer treated with radiotherapy. Materials and methods Parents and offspring were profiled for eight hypervariable minisatellite loci (B6.7, CEB1, CEB15, CEB25, CEB36, MS1, MS31, MS32) by Southern blotting. Results Seven paternal mutations were observed for 130 informative alleles in 18 offspring from 11 radiation-exposed fathers (mean preconceptional dose for offspring 0.29 Gy, range <0.01 - 1.2 Gy), compared to six mutations for 146 informative alleles in 21 offspring from 13 unexposed fathers. No statistically significant difference between the total paternal mutation rates was observed (5.4% for exposed fathers and 4.1% for unexposed fathers). Three maternal mutations were observed for 148 informative alleles in 21 offspring from 13 radiation-exposed mothers (mean preconceptional dose for offspring 0.71 Gy, range <0.01 - 9.2 Gy), compared to one mutation for 130 informative alleles in 18 offspring from 11 unexposed mothers. Again, no statistically significant difference was observed between the total maternal mutation rates (2.0% for exposed mothers and 0.8% for unexposed mothers). Conclusions The data from this pilot study demonstrate no statistically significant increase in germline minisatellite mutation rate associated with radiotherapy for childhood and adolescent cancer. PMID:16638712

  16. A cognitive-existential intervention to improve existential and global quality of life in cancer patients: A pilot study.

    PubMed

    Gagnon, Pierre; Fillion, Lise; Robitaille, Marie-Anik; Girard, Michèle; Tardif, François; Cochrane, Jean-Philippe; Le Moignan Moreau, Joanie; Breitbart, William

    2015-08-01

    We developed a specific cognitive-existential intervention to improve existential distress in nonmetastatic cancer patients. The present study reports the feasibility of implementing and evaluating this intervention, which involved 12 weekly sessions in both individual and group formats, and explores the efficacy of the intervention on existential and global quality of life (QoL) measures. Some 33 nonmetastatic cancer patients were randomized between the group intervention, the individual intervention, and the usual condition of care. Evaluation of the intervention on the existential and global QoL of patients was performed using the existential well-being subscale and the global scale of the McGill Quality of Life (MQoL) Questionnaire. All participants agreed that their participation in the program helped them deal with their illness and their personal life. Some 88.9% of participants agreed that this program should be proposed for all cancer patients, and 94.5% agreed that this intervention helped them to reflect on the meaning of their life. At post-intervention, both existential and psychological QoL improved in the group intervention versus usual care (p = 0.086 and 0.077, respectively). At the three-month follow-up, global and psychological QoL improved in the individual intervention versus usual care (p = 0.056 and 0.047, respectively). This pilot study confirms the relevance of the intervention and the feasibility of the recruitment and randomization processes. The data strongly suggest a potential efficacy of the intervention for existential and global quality of life, which will have to be confirmed in a larger study.

  17. A cognitive–existential intervention to improve existential and global quality of life in cancer patients: A pilot study

    PubMed Central

    GAGNON, PIERRE; FILLION, LISE; ROBITAILLE, MARIE-ANIK; GIRARD, MICHÈLE; TARDIF, FRANÇOIS; COCHRANE, JEAN-PHILIPPE; LE MOIGNAN MOREAU, JOANIE; BREITBART, WILLIAM

    2017-01-01

    Objective We developed a specific cognitive–existential intervention to improve existential distress in nonmetastatic cancer patients. The present study reports the feasibility of implementing and evaluating this intervention, which involved 12 weekly sessions in both individual and group formats, and explores the efficacy of the intervention on existential and global quality of life (QoL) measures. Method Some 33 nonmetastatic cancer patients were randomized between the group intervention, the individual intervention, and the usual condition of care. Evaluation of the intervention on the existential and global QoL of patients was performed using the existential well-being subscale and the global scale of the McGill Quality of Life (MQoL) Questionnaire. Results All participants agreed that their participation in the program helped them deal with their illness and their personal life. Some 88.9% of participants agreed that this program should be proposed for all cancer patients, and 94.5% agreed that this intervention helped them to reflect on the meaning of their life. At post-intervention, both existential and psychological QoL improved in the group intervention versus usual care (p = 0.086 and 0.077, respectively). At the three-month follow-up, global and psychological QoL improved in the individual intervention versus usual care (p = 0.056 and 0.047, respectively). Significance of results This pilot study confirms the relevance of the intervention and the feasibility of the recruitment and randomization processes. The data strongly suggest a potential efficacy of the intervention for existential and global quality of life, which will have to be confirmed in a larger study. PMID:25050872

  18. Hippocampal and Cognitive Function, Exercise, and Ovarian Cancer: A Pilot Study

    DTIC Science & Technology

    2015-08-01

    the hippocampus and subsequently offset memory decline. 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF... hippocampus and subsequently offset memory decline. 2 KEYWORDS: Physical activity interventions, ovarian cancer treatment, chemotherapy-induced...chemotherapy complaint in a single cancer: problems with memory in patients with ovarian cancer. We focus on this problem for three reasons: 1

  19. Pilot study of bone mineral density in breast cancer patients treated with adjuvant chemotherapy

    NASA Technical Reports Server (NTRS)

    Headley, J. A.; Theriault, R. L.; LeBlanc, A. D.; Vassilopoulou-Sellin, R.; Hortobagyi, G. N.

    1998-01-01

    The objective of this cross-sectional study was to determine lumbar spine bone mineral density (BMD) in breast cancer patients previously treated with adjuvant chemotherapy. Sixteen of 27 patients who received adjuvant chemotherapy became permanently amenorrheic as a result of chemotherapy. BMD was measured at the lumbar spine using dual energy X-ray absorptiometry (DEXA). Chemotherapy drugs and dosages along with a history of risk factors for reduced bone density including activity level, tobacco and/or alcohol use, metabolic bone disease, family history, and hormone exposure were identified. Results showed that women who became permanently amenorrheic as a result of chemotherapy had BMD 14% lower than women who maintained menses after chemotherapy. Chemotherapy-treated women who maintained ovarian function had normal BMD. This study suggests that women who have premature menopause as a result of chemotherapy for breast cancer are at increased risk of bone loss and may be at risk for early development of osteoporosis. Women who maintain menses do not appear to be at risk for accelerated trabecular bone loss.

  20. Swallowing appliance: intraoral reshaping prosthesis for dysphagia secondary to oral floor cancer: a pilot study.

    PubMed

    Koyama, Yuji; Ota, Yoshihide; Sakaizumi, Kazuo; Simoda, Naoshi; Kodama, Mitsuhiko; Toyokura, Minoru; Masakado, Yoshihisa

    2014-11-01

    Patients with oral floor cancer often have difficulty swallowing solid foods. The aim of this study was to improve the propulsion of solid foods using a swallowing appliance (SW-A). Subjects comprised three patients with oral floor cancer who had undergone curative surgery. Each participant was asked to swallow gelatin under three conditions: without an SW-A, with a maxillary SW-A, and with both maxillary and mandibular SW-As. This procedure was repeated thrice with three volumes of gelatin (2.5, 5, and 7.5 ml), with videofluorographic swallowing study. Swallowing was assessed on the basis of whether the participant could propel the gelatin from the oral cavity to the pharynx. No subject could propel 2.5 ml of gelatin to the pharynx without an SW-A or with only a maxillary SW-A in place. When both SW-As were used, all subjects could propel all three volumes of gelatin. The mandibular SW-A complemented the compensatory effects of the maxillary SW-A.

  1. Pilot study of bone mineral density in breast cancer patients treated with adjuvant chemotherapy

    NASA Technical Reports Server (NTRS)

    Headley, J. A.; Theriault, R. L.; LeBlanc, A. D.; Vassilopoulou-Sellin, R.; Hortobagyi, G. N.

    1998-01-01

    The objective of this cross-sectional study was to determine lumbar spine bone mineral density (BMD) in breast cancer patients previously treated with adjuvant chemotherapy. Sixteen of 27 patients who received adjuvant chemotherapy became permanently amenorrheic as a result of chemotherapy. BMD was measured at the lumbar spine using dual energy X-ray absorptiometry (DEXA). Chemotherapy drugs and dosages along with a history of risk factors for reduced bone density including activity level, tobacco and/or alcohol use, metabolic bone disease, family history, and hormone exposure were identified. Results showed that women who became permanently amenorrheic as a result of chemotherapy had BMD 14% lower than women who maintained menses after chemotherapy. Chemotherapy-treated women who maintained ovarian function had normal BMD. This study suggests that women who have premature menopause as a result of chemotherapy for breast cancer are at increased risk of bone loss and may be at risk for early development of osteoporosis. Women who maintain menses do not appear to be at risk for accelerated trabecular bone loss.

  2. Effects of yoga on arm volume among women with breast cancer related lymphedema: A pilot study.

    PubMed

    Fisher, Mary Insana; Donahoe-Fillmore, Betsy; Leach, Laura; O'Malley, Colleen; Paeplow, Cheryl; Prescott, Tess; Merriman, Harold

    2014-10-01

    Lymphedema affects 3-58% of survivors of breast cancer and can result in upper extremity impairments. Exercise can be beneficial in managing lymphedema. Yoga practice has been minimally studied for its effects on breast cancer related lymphedema (BCRL). The purpose of this study was to determine the effect of yoga on arm volume, quality of life (QOL), self-reported arm function, and hand grip strength in women with BCRL. Six women with BCRL participated in modified Hatha yoga 3×/week for 8 weeks. Compression sleeves were worn during yoga sessions. Arm volume, QOL, self-reported arm function, and hand grip strength were measured at baseline, half-way, and at the conclusion of yoga practice. Arm volume significantly decreased from baseline (2423.3 ml ± 597.2) to final measures (2370.8 ml ± 577.2) (p = .02). No significant changes in QOL (p = .12), self-reported arm function (p = .34), or hand grip strength (p = .26) were found. Yoga may be beneficial in the management of lymphedema.

  3. Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China.

    PubMed

    He, Lixian; Zhou, Caicun; Zhao, Su; Weng, Heng; Yang, Guowang

    2015-03-01

    This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5-7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy.

  4. Efficacy of guided imagery with theta music for advanced cancer patients with dyspnea: a pilot study.

    PubMed

    Lai, Wei-Shu; Chao, Co-Shi Chantal; Yang, Wan-Ping; Chen, Ching-Huey

    2010-10-01

    Dyspnea is a frequent and devastating symptom among advanced cancer patients for which improved and low-cost palliative techniques are needed. A one-group repeated measures research design investigated the efficacy of guided imagery (GI) with theta music (M) on dyspnea in advanced cancer patients. The intervention consisted of four periods: (a) pretest; (b) intervention with peaceful non-M; (c) intervention with 10 min of GI with M (GI/M), with the first and last 3 min being M only (i.e., the middle 4 min was GI/M); and (d) posttest. Dyspnea outcome was measured with the Modified Borg Scale (MBS) for self-reported evaluation of dyspneic symptoms. Physiological parameters measured were pulse oxygen saturation (SpO(2)), end-tidal CO( 2) (EtCO(2)), heart rate (HR), and respiratory rate (RR). Posttest qualitative data were obtained via interview for subjective patient experience. Participants included 53 patients, 33% with lung cancer. GI/M produced a significant decrease in MBS scores; 90% of the subjects gave positive qualitative reviews of GI/M. SpO(2) did not change significantly over time. GI/M significantly increased EtCO(2), decreased RR, and decreased HR. This study demonstrates that GI/M is a useful intervention for palliative care of patients with dyspnea. M alone was demonstrated to be effective, while soothing non-M was not effective. GI/M was more effective than M alone. GI/M should be considered low-cost end-of-life palliative care for dyspnea.

  5. Chemotherapy altered brain functional connectivity in women with breast cancer: a pilot study.

    PubMed

    Dumas, Julie A; Makarewicz, Jenna; Schaubhut, Geoffrey J; Devins, Robert; Albert, Kimberly; Dittus, Kim; Newhouse, Paul A

    2013-12-01

    Adjuvant chemotherapy is associated with improvements in long-term cancer survival. However, reports of cognitive impairment following treatment emphasize the importance of understanding the long-term effects of chemotherapy on brain functioning. Cognitive deficits found in chemotherapy patients suggest a change in brain functioning that affects specific cognitive domains such as attentional processing and executive functioning. This study examined the processes potentially underlying these changes in cognition by examining brain functional connectivity pre- and post-chemotherapy in women with breast cancer. Functional connectivity examines the temporal correlation between spatially remote brain regions in an effort to understand how brain networks support specific cognitive functions. Nine women diagnosed with breast cancer completed a functional magnetic resonance imaging (fMRI) session before chemotherapy, 1 month after, and 1 year after the completion of chemotherapy. Seed-based functional connectivity analyses were completed using seeds in the intraparietal sulcus (IPS) to examine connectivity in the dorsal anterior attention network and in the posterior cingulate cortex (PCC) to examine connectivity in the default mode network. Results showed decreased functional connectivity 1 month after chemotherapy that partially returned to baseline at 1 year in the dorsal attention network. Decreased connectivity was seen in the default mode network at 1 month and 1 year following chemotherapy. In addition, increased subjective memory complaints were noted at 1 month and 1 year post-chemotherapy. These findings suggest a detrimental effect of chemotherapy on brain functional connectivity that is potentially related to subjective cognitive assessment.

  6. Healthcare Professionals' Knowledge of Family Psychosocial Problems in Pediatric Cancer: A Pilot Study.

    PubMed

    Barrera, Maru; Rokeach, Alan; Yogalingam, Priyanga; Hancock, Kelly; Johnston, Donna L; Cataudella, Danielle; Cassidy, Marilyn; Punnett, Angela S; Shama, Wendy

    2016-01-01

    Best practice guidelines for the treatment of cancer now advocate for a child- and family-centered model of care and a psychosocial model of risk prevention. However, healthcare professionals (HCPs) report a number of barriers preventing the implementation of psychosocial care, including an absence of tools to help identify psychosocial problems within the family. The aims of this study are to (1) explore the psychometric properties of the Psychosocial Care Checklist (PCCL) and (2) test if the PCCL can differentiate the degree to which HCPs are aware of psychosocial problems within the family (patient, siblings, parents) of a child with cancer. Thirty-seven HCPs caring for a child with cancer completed the PCCL at time 1 (2-4 weeks after diagnosis) and 29 HCPs completed the PCCL at time 2 (2-3 weeks after). The PCCL had strong test-retest reliability for all domains (α > .60) and strong internal consistency for the total PCCL (α = .91). Interrater reliability was moderate for the oncologist-nurse dyad with regard to sibling knowledge (r = 0.56) and total psychosocial knowledge (r = 0.65). Social workers were significantly more knowledgeable than both nurses and oncologists about total family problems (P = .01) and sibling problems (P = .03). Preliminary findings suggest that the PCCL has adequate test-retest reliability and validity and is useful in differentiating the degree to which HCPs are aware of psychosocial problems within the family, with social workers being the most knowledgeable. Using the PCCL may help HCPs to identify psychosocial problems within the family and appropriately allocate psychosocial resources.

  7. Triple-negative breast cancer: multipronged approach, single-arm pilot phase II study.

    PubMed

    Recchia, Francesco; Candeloro, Giampiero; Desideri, Giovambattista; Necozione, Stefano; Recchia, Cornelia O C; Cirulli, Vincenzo; Rea, Silvio

    2012-08-01

    Anthracyclines (A) and taxanes (T) are standard first-line chemotherapy agents for patients with advanced breast cancer. Platinum analogues have also shown activity in the triple-negative breast cancer (TNBC) histology, but clinical data are limited. Here we report the long-term follow-up of a phase II study on TNBC treated with a combined modality therapy, including induction with AT, cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) with concurrent radiation therapy, and a dose-dense consolidation chemotherapy (HDCT) with carboplatin (CBDCA), ifosfamide (IFX), etoposide (VP-16). Patients' median age was 44 years, with 73% premenopausal. Epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2) were administered to 70 patients with TNBC: as neoadjuvant and adjuvant therapy to 12 and 58 patients, respectively. Postoperative radiation therapy, 5000 cGy, was delivered, synchronous with triweekly CMF. After radiation therapy, two courses of HDCT with CBDCA, IFX, VP-16, were given, with hematological growth factors. After a median follow-up of 81 months, all patients were evaluable for toxicity and response. Most important toxicity were grade 3 skin reaction and grade 4 hematological in 3% and 31% of patients, respectively. Pathological complete response was observed in 25% of patients receiving preoperative chemotherapy. Treatment failures were as follows: eight visceral, four contralateral breast cancer, four locoregional, and one leukemia. Five-year progression-free survival and overall survival rate were 78% and 91%, respectively. Induction chemotherapy, followed by chemoradiation therapy and HDCT, provides a prolonged disease-free period and a significant increase in overall survival in TNBC, with an acceptable toxicity profile.

  8. Triple-negative breast cancer: multipronged approach, single-arm pilot phase II study

    PubMed Central

    Recchia, Francesco; Candeloro, Giampiero; Desideri, Giovambattista; Necozione, Stefano; Recchia, Cornelia O C; Cirulli, Vincenzo; Rea, Silvio

    2012-01-01

    Anthracyclines (A) and taxanes (T) are standard first-line chemotherapy agents for patients with advanced breast cancer. Platinum analogues have also shown activity in the triple-negative breast cancer (TNBC) histology, but clinical data are limited. Here we report the long-term follow-up of a phase II study on TNBC treated with a combined modality therapy, including induction with AT, cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) with concurrent radiation therapy, and a dose-dense consolidation chemotherapy (HDCT) with carboplatin (CBDCA), ifosfamide (IFX), etoposide (VP-16). Patients' median age was 44 years, with 73% premenopausal. Epirubicin 75 mg/m2 and docetaxel 75 mg/m2 were administered to 70 patients with TNBC: as neoadjuvant and adjuvant therapy to 12 and 58 patients, respectively. Postoperative radiation therapy, 5000 cGy, was delivered, synchronous with triweekly CMF. After radiation therapy, two courses of HDCT with CBDCA, IFX, VP-16, were given, with hematological growth factors. After a median follow-up of 81 months, all patients were evaluable for toxicity and response. Most important toxicity were grade 3 skin reaction and grade 4 hematological in 3% and 31% of patients, respectively. Pathological complete response was observed in 25% of patients receiving preoperative chemotherapy. Treatment failures were as follows: eight visceral, four contralateral breast cancer, four locoregional, and one leukemia. Five-year progression-free survival and overall survival rate were 78% and 91%, respectively. Induction chemotherapy, followed by chemoradiation therapy and HDCT, provides a prolonged disease-free period and a significant increase in overall survival in TNBC, with an acceptable toxicity profile. PMID:23342258

  9. Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study

    PubMed Central

    Krishnaswamy, Priyadharshini; Nair, Shoba

    2016-01-01

    Background: The pain associated with cancer is highly detrimental to the quality of life of the affected individuals. It also contributes to the anxiety of the patient. There is a need for a nonpharmacological approach in addition to the pharmacological therapy for the management of the pain for a more holistic improvement in the individual. With this study, we wish to achieve this through music. Objective: To assess the effect of music therapy on pain scores and anxiety levels of cancer patients with pain. Study Design: In this quantitative study, a comparative study was done on fourteen cancer patients admitted for pain relief under the Department of Pain and Palliative Medicine, of a tertiary care hospital, having moderate to severe pain (numerical pain rating scale [NRS] – of 4 to 10). Subjects and Methods: Convenience sampling was used. Patients were allocated to test group or control group nonrandomly. The test group patients were subjected to music therapy for 20 min while the control group patients were kept occupied by talking to them for 20 min. The NRS scale was used to assess the pre- and post-interventional pain scores and the Hamilton anxiety rating scale was used to assess the pre- and post-interventional anxiety scores in the two groups. Statistics: Student's t-test was used for comparing the pre- and post-interventional data. Two sample t-test was used to compare the data obtained from the control and study groups. Results: Statistically significant reduction seen in the pain scores in the test group after music therapy (P = 0.003). No statistically significant reduction seen in the pain score in the control group (P = 0.356). There was a statistically significant reduction in the postintervention pain scores in the test group compared to the control group (P = 0.034). The reduction in anxiety levels in both groups after intervention was not statistically significant. Conclusion: Music therapy was found to lower the pain score of a patient who

  10. Robust Intratumor Partitioning to Identify High-Risk Subregions in Lung Cancer: A Pilot Study.

    PubMed

    Wu, Jia; Gensheimer, Michael F; Dong, Xinzhe; Rubin, Daniel L; Napel, Sandy; Diehn, Maximilian; Loo, Billy W; Li, Ruijiang

    2016-08-01

    To develop an intratumor partitioning framework for identifying high-risk subregions from (18)F-fluorodeoxyglucose positron emission tomography (FDG-PET) and computed tomography (CT) imaging and to test whether tumor burden associated with the high-risk subregions is prognostic of outcomes in lung cancer. In this institutional review board-approved retrospective study, we analyzed the pretreatment FDG-PET and CT scans of 44 lung cancer patients treated with radiation therapy. A novel, intratumor partitioning method was developed, based on a 2-stage clustering process: first at the patient level, each tumor was over-segmented into many superpixels by k-means clustering of integrated PET and CT images; next, tumor subregions were identified by merging previously defined superpixels via population-level hierarchical clustering. The volume associated with each of the subregions was evaluated using Kaplan-Meier analysis regarding its prognostic capability in predicting overall survival (OS) and out-of-field progression (OFP). Three spatially distinct subregions were identified within each tumor that were highly robust to uncertainty in PET/CT co-registration. Among these, the volume of the most metabolically active and metabolically heterogeneous solid component of the tumor was predictive of OS and OFP on the entire cohort, with a concordance index or CI of 0.66-0.67. When restricting the analysis to patients with stage III disease (n=32), the same subregion achieved an even higher CI of 0.75 (hazard ratio 3.93, log-rank P=.002) for predicting OS, and a CI of 0.76 (hazard ratio 4.84, log-rank P=.002) for predicting OFP. In comparison, conventional imaging markers, including tumor volume, maximum standardized uptake value, and metabolic tumor volume using threshold of 50% standardized uptake value maximum, were not predictive of OS or OFP, with CI mostly below 0.60 (log-rank P>.05). We propose a robust intratumor partitioning method to identify clinically relevant, high

  11. Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study.

    PubMed

    Krishnaswamy, Priyadharshini; Nair, Shoba

    2016-01-01

    The pain associated with cancer is highly detrimental to the quality of life of the affected individuals. It also contributes to the anxiety of the patient. There is a need for a nonpharmacological approach in addition to the pharmacological therapy for the management of the pain for a more holistic improvement in the individual. With this study, we wish to achieve this through music. To assess the effect of music therapy on pain scores and anxiety levels of cancer patients with pain. In this quantitative study, a comparative study was done on fourteen cancer patients admitted for pain relief under the Department of Pain and Palliative Medicine, of a tertiary care hospital, having moderate to severe pain (numerical pain rating scale [NRS] - of 4 to 10). Convenience sampling was used. Patients were allocated to test group or control group nonrandomly. The test group patients were subjected to music therapy for 20 min while the control group patients were kept occupied by talking to them for 20 min. The NRS scale was used to assess the pre- and post-interventional pain scores and the Hamilton anxiety rating scale was used to assess the pre- and post-interventional anxiety scores in the two groups. Student's t-test was used for comparing the pre- and post-interventional data. Two sample t-test was used to compare the data obtained from the control and study groups. Statistically significant reduction seen in the pain scores in the test group after music therapy (P = 0.003). No statistically significant reduction seen in the pain score in the control group (P = 0.356). There was a statistically significant reduction in the postintervention pain scores in the test group compared to the control group (P = 0.034). The reduction in anxiety levels in both groups after intervention was not statistically significant. Music therapy was found to lower the pain score of a patient who had received standard palliative care for pain reduction. It was also more effective than the

  12. A Pilot Study of a Culturally Targeted Video Intervention to Increase Participation of African American Patients in Cancer Clinical Trials

    PubMed Central

    Libin, Alexander V.; Wang, Hong; Swain, Sandra M.

    2012-01-01

    Purpose. Barriers to clinical trial participation among African American cancer patients are well characterized in the literature. Attitudinal barriers encompassing fear, distrust, and concerns about ethical misconduct are also well documented. To increase trial accrual, these attitudes must be adequately addressed, yet there remains a lack of targeted interventions toward this end. We developed a 15-minute culturally targeted video designed to impact six specific attitudes of African American cancer patients toward therapeutic trials. We conducted a pilot study to test in the first such intervention to increase intention to enroll. Patients and Methods. The primary study outcome was self-reported likelihood to participate in a therapeutic trial. Using a mixed methods approach, we developed the Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) instrument, a 30-item questionnaire measuring six attitudinal barriers to African American trial participation. We enrolled 108 eligible active treatment patients at a large urban cancer institute. McNemar's test for matched pairs was used to assess changes in attitudes and likelihood to enroll in a clinical trial at baseline and immediately after the video. Pre- and post-video AIET summative scores were analyzed by paired t-test for each attitudinal barrier. Results. Patients' likelihood of enrolling in a clinical trial significantly increased post-video with 36% of the sample showing positive changes in intention [McNemar's χ2 = 33.39, p < .001]. Paired t-tests showed significant changes in all six attitudinal barriers measured via AIET summative scores from pre- to post-video. Conclusion. These data suggest utility of our video for increasing African American participation in clinical trials. PMID:22639112

  13. Importance of sentinel lymph nodes in colorectal cancer: a pilot study.

    PubMed

    Köksal, Hande; Bostanci, Hasan; Mentes, B Bülent

    2007-01-01

    Accurate identification of lymph nodes involved in metastases is vitally important for predicting survival, and it facilitates decision making with regard to adjuvant therapy. The study described here, which was undertaken to evaluate the role of sentinel lymph node mapping in refining the staging of colorectal cancer, was performed prospectively in 19 patients with colorectal cancer who underwent surgery from January to July 2005. Sentinel lymph node sampling was performed during each operation with isosulfan blue dye. Additional immunohistochemical staining was performed only if the sentinel nodes were negative for metastasis. In 18 of 19 patients, at least 1 sentinel node was identified. In 5 of 18 patients, sentinel nodes were positive for metastasis, and in 3 of 5, the sentinel node was the only node containing metastasis that was detected by immunohistochemical staining. In 3 patients, metastases in nonsentinel lymph nodes were detected by hematoxylin and eosin staining; these were determined to be false-negative results. Upstaging associated with sentinel lymph node mapping may reveal disease that might otherwise remain undetected by conventional methods. Patients who are upstaged may benefit from adjuvant therapies that have been shown to improve survival.

  14. Cognitive Existential Couple Therapy for newly diagnosed prostate cancer patients and their partners: a descriptive pilot study.

    PubMed

    Collins, Anna L; Love, Anthony W; Bloch, Sidney; Street, Annette F; Duchesne, Gillian M; Dunai, Judy; Couper, Jeremy W

    2013-02-01

    This paper aims to describe 'Cognitive Existential Couple Therapy' (CECT), a novel couples-based intervention for men with early stage prostate cancer (PCa) and their partners, and to report preliminary findings from a pilot study that investigated the acceptability and feasibility of the intervention and the measures to be used in a subsequent randomised controlled trial. A manualised CECT programme was delivered to 12 couples facing a diagnosis of PCa within the previous 12 months by psychiatrists and clinical psychologists. Participants completed measures of psychological distress, marital function and coping pattern before and after CECT. Semi-structured interviews were conducted with nine couples shortly after the completion of CECT. The application of CECT was both feasible and acceptable as indicated by favourable participant compliance (10 of the 12 couples attended all six designated sessions), completion of measures before and after CECT and participation in semi-structured interviews by nine couples. Preliminary results included reduced levels of avoidance and hyperarousal after the programme, with this effect stronger in partners than in patients. Interviews demonstrated that couples valued the therapist's contribution to their overall care. Previous research suggests that a couple-focused psychological intervention is desirable in the context of early stage PCa. This pilot study has established that CECT is acceptable, feasible and valued by couples facing a recent PCa diagnosis and demonstrates a potential for reduced psychological distress following CECT. A randomised controlled trial is currently being undertaken to validate the efficacy of this novel approach. Copyright © 2011 John Wiley & Sons, Ltd.

  15. Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial.

    PubMed

    Parekh, Niyati; Jiang, Jieying; Buchan, Marissa; Meyers, Marleen; Gibbs, Heather; Krebs, Paul

    2017-06-17

    Knowledge of nutrition among breast cancer patients is insufficient, despite their motivation to seek valid information about healthy food choices. This study examines the feasibility of nutrition education workshops for cancer survivors, to inform the design of a multi-center intervention. Fifty-nine female English-speaking breast cancer patients, who had completed treatment, were enrolled. Participants were randomized to the intervention or control group. The intervention group attended six nutrition education sessions, and the control group received brochures. Measurements were done at baseline and 3-month follow-up and included the Assessment Instrument for Breast Cancer (NLit-BCa), fruit/vegetable and general health literacy screeners. Height and weight were measured. Changes in nutrition literacy, health literacy, and food intake from baseline to follow-up (within-group change) were calculated for both groups (effect sizes were reported as Cohen's d). Participants were mostly white, with a mean age of 58 years, BMI of 31.6 kg/m(2), and had college degrees. Follow-up rates were high (89% = control and 77% = intervention group). At baseline, participants scored high for most NLit-BCa assessment components except food portions in both groups. At the 3-month follow-up, effect sizes (d) on the NLit-BCa ranged from -0.5 to 0.16. The study met its recruitment goals within 6 months. Focus groups indicated that (a) attending six sessions was acceptable, (b) patients found social/emotional support, (c) improvements should include information for special diets and booster sessions. This pilot study suggests that the intervention was acceptable and that scaling up of this intervention is feasible and could provide benefit to breast cancer survivors.

  16. Cancer treatment, symptom monitoring, and self-care in adults: pilot study.

    PubMed

    Williams, Phoebe Dauz; Piamjariyakul, Ubolrat; Ducey, Kathleen; Badura, Jody; Boltz, Kristin D; Olberding, Karmen; Wingate, Anita; Williams, Arthur R

    2006-01-01

    A descriptive study was conducted on self-reported symptoms and self-care by 37 adults receiving chemotherapy primarily for leukemia, lymphomas, or breast cancer or radiation therapy for head and neck or lung cancers. The Therapy-Related Symptom Checklist and demographic and interview forms on self-care for identified symptoms were used. Severe symptoms on the Therapy-Related Symptom Checklist subscales fatigue, eating, nausea, pain, numbness in fingers/toes, hair loss, and constipation were reported by patients on chemotherapy. Those on radiation therapy reported severe symptoms on the eating, fatigue, skin changes, oropharynx, and constipation subscales.Self-care strategies were in the following categories, using complementary medicine as framework: diet/nutrition/lifestyle change (eg, use of nutritional supplements; modifications of food and of eating habits; naps, sleep, and rest); mind/body control (eg, relaxation methods, prayer, music, attending granddaughter's sports events); biologic treatments (vitamins); herbal treatments (green mint tea); and ethnomedicine (lime juice and garlic). The first category was predominantly used by patients in both treatment types. Medications were prescribed also to help control symptoms (eg, pain and nausea). Symptom monitoring and self-care for symptoms identified may be facilitated by the Therapy-Related Symptom Checklist; based on reported symptom severity, care providers may prioritize interventions. A larger study needs to be done on (a) the use of the Therapy-Related Symptom Checklist as a clinical tool to assess symptoms that oncology patients experience during therapy; (b) whether care providers, based on patient-reported symptom severity, can prioritize interventions--and how this influences the efficiency of care; (c) the self-care strategies used by patients on chemotherapy or radiation therapy or both; and (d) how useful these strategies are in alleviating symptoms.

  17. Randomized controlled pilot study of mindfulness-based stress reduction for persistently fatigued cancer survivors.

    PubMed

    Johns, Shelley A; Brown, Linda F; Beck-Coon, Kathleen; Monahan, Patrick O; Tong, Yan; Kroenke, Kurt

    2015-08-01

    Cancer-related fatigue (CRF) is one of the most common, persistent, and disabling symptoms associated with cancer and its treatment. Evidence-based treatments that are acceptable to patients are critically needed. This study examined the efficacy of mindfulness-based stress reduction (MBSR) for CRF and related symptoms. A sample of 35 cancer survivors with clinically significant CRF was randomly assigned to a 7-week MBSR-based intervention or wait-list control group. The intervention group received training in mindfulness meditation, yoga, and self-regulatory responses to stress. Fatigue interference (primary outcome) and a variety of secondary outcomes (e.g., fatigue severity, vitality, disability, depression, anxiety, and sleep disturbance) were assessed at baseline, post-intervention, and 1-month follow-up. Bonferroni correction was employed to account for multiple comparisons. Controls received the intervention after the 1-month follow-up. Participants in both groups were followed for 6 months after completing their respective MBSR courses to assess maintenance of effects. Compared to controls, the MBSR group reported large post-intervention reductions as assessed by effect sizes (d) in the primary outcome, fatigue interference (d = -1.43, p < 0.001), along with fatigue severity (d = -1.55, p < 0.001), vitality (d = 1.29, p < 0.001), depression (d = -1.30, p < 0.001), and sleep disturbance (d = -0.74, p = 0.001). Results were maintained or strengthened at 1-month follow-up, the point at which significant improvements in disability (d = -1.22, p < 0.002) and anxiety (d = -0.98, p = 0.002) occurred. Improvements in all outcomes were maintained 6 months after completing the course. MBSR adherence was high, with 90% attendance across groups and high rates of participant-reported home practice of mindfulness. Mindfulness-based stress reduction is a promising treatment for CRF and associated symptoms

  18. Cervical Microbiome and Cytokine Profile at Various Stages of Cervical Cancer: A Pilot Study

    PubMed Central

    Bahena-Román, Margarita; Téllez-Sosa, Juan; Martínez-Barnetche, Jesús; Cortina-Ceballos, Bernardo; López-Estrada, Guillermina; Delgado-Romero, Karina; Burguete-García, Ana I.; Cantú, David; García-Carrancá, Alejandro; Madrid-Marina, Vicente

    2016-01-01

    Cervical cancer (CC) is caused by high-risk human papillomavirus persistence due to the immunosuppressive tumor microenvironment mediated by cytokines. Vaginal microbiota determines the presence of certain cytokines locally. We assessed the association between cervical microbiota diversity and the histopathological diagnosis of each stage of CC, and we evaluated mRNA cervical expression levels of IL-4, IL-6, IL-10, TGF-β1, TNF-α and IFN-γ across the histopathological diagnosis and specific bacterial clusters. We determined the cervical microbiota by high throughput sequencing of 16S rDNA amplicons and classified it in community state types (CST). Mean difference analyses between alpha-diversity and histopathological diagnosis were carried out, as well as a β-diversity analysis within the histological diagnosis. Cervical cytokine mRNA expression was analyzed across the CSTs and the histopathological diagnoses. We found a significant difference in microbiota's diversity in NCL-HPV negative women vs those with squamous intraepithelial lesions (SIL) and CC(p = 0.006, p = 0.036).When β-diversity was evaluated, the CC samples showed the highest variation within groups (p<0.0006) and the largest distance compared to NCL-HPV negative ones (p<0.00001). The predominant bacteria in women with normal cytology were L. crispatus and L. iners, whereas for SIL, it was Sneathia spp. and for CC, Fusobacterium spp. We found higher median cervical levels of IL-4 and TGF-β1 mRNA in the CST dominated by Fusobacterium spp. These results suggest that the cervical microbiota may be implicated in cervical cancer pathology. Further cohort studies are needed to validate these findings. PMID:27115350

  19. Quantitative Ultrasonic Evaluation of Radiation-Induced Late Tissue Toxicity: Pilot Study of Breast Cancer Radiotherapy

    SciTech Connect

    Liu Tian; Zhou Jun; Yoshida, Emi J.; Woodhouse, Shermian A.; Schiff, Peter B.; Wang, Tony J.C.; Lu Zhengfeng; Pile-Spellman, Eliza; Zhang Pengpeng; Kutcher, Gerald J.

    2010-11-01

    Purpose: To investigate the use of advanced ultrasonic imaging to quantitatively evaluate normal-tissue toxicity in breast-cancer radiation treatment. Methods and Materials: Eighteen breast cancer patients who received radiation treatment were enrolled in an institutional review board-approved clinical study. Radiotherapy involved a radiation dose of 50.0 to 50.4 Gy delivered to the entire breast, followed by an electron boost of 10.0 to 16.0 Gy delivered to the tumor bed. Patients underwent scanning with ultrasound during follow-up, which ranged from 6 to 94 months (median, 22 months) postradiotherapy. Conventional ultrasound images and radio-frequency (RF) echo signals were acquired from treated and untreated breasts. Three ultrasound parameters, namely, skin thickness, Pearson coefficient, and spectral midband fit, were computed from RF signals to measure radiation-induced changes in dermis, hypodermis, and subcutaneous tissue, respectively. Ultrasound parameter values of the treated breast were compared with those of the untreated breast. Ultrasound findings were compared with clinical assessment using Radiation Therapy Oncology Group (RTOG) late-toxicity scores. Results: Significant changes were observed in ultrasonic parameter values of the treated vs. untreated breasts. Average skin thickness increased by 27.3%, from 2.05 {+-} 0.22mm to 2.61 {+-} 0.52mm; Pearson coefficient decreased by 31.7%, from 0.41 {+-} 0.07 to 0.28 {+-} 0.05; and midband fit increased by 94.6%, from -0.92 {+-} 7.35 dB to 0.87 {+-} 6.70 dB. Ultrasound evaluations were consistent with RTOG scores. Conclusions: Quantitative ultrasound provides a noninvasive, objective means of assessing radiation-induced changes to the skin and subcutaneous tissue. This imaging tool will become increasingly valuable as we continue to improve radiation therapy technique.

  20. Nutritional status of patients with locally advanced pancreatic cancer: a pilot study.

    PubMed

    Ferrucci, Leah M; Bell, Diana; Thornton, Jennifer; Black, Glenda; McCorkle, Ruth; Heimburger, Douglas C; Saif, Muhammad Wasif

    2011-11-01

    Nutritional status may influence quality of life and prognosis among pancreatic cancer patients, yet few studies describe measures of nutritional status during treatment. We evaluated the nutritional status of locally advanced pancreatic cancer (LAPC) patients undergoing chemoradiotherapy who received baseline nutritional assessment and counseling. Fourteen newly diagnosed LAPC patients enrolled in phase I/II trials of capecitabine with concomitant radiotherapy were assessed for baseline clinical nutrition measures (body mass index, albumin, weight loss, total energy, and protein intake). Participants completed the Anorexia/Cachexia Subscale (A/CS) questionnaire at baseline and during the 6 weeks of treatment. We evaluated associations between baseline characteristics and subsequent A/CS scores with linear regression and changes in A/CS were assessed with the paired t test. We observed a statistically significant increase in mean A/CS between baseline [24.9, standard deviation (SD) = 9.7] and end of treatment (29.9, SD = 6.2). Controlling for baseline A/CS score, only weight loss greater than 5% of body weight over 1 month was associated with A/CS scores at 6 weeks (β = 10.558, standard error = 3.307, p value = 0.009) and mean A/CS scores during the last 3 weeks of treatment (β = 12.739, standard error = 2.251, p value = 0.001). After 6 weeks of chemoradiotherapy, LAPC patients reported a statistically significant improvement in appetite and weight concerns. Increases in AC/S scores were associated with higher baseline A/CS scores and weight loss of 5% or more during 1 month. Further research is needed to determine the impact of nutritional support during treatment, as improvements in this domain may impact LAPC patients' overall quality of life.

  1. Evaluating healing for cancer in a community setting from the perspective of clients and healers: a pilot study.

    PubMed

    Vaghela, C; Robinson, N; Gore, J; Peace, B; Lorenc, A

    2007-11-01

    The real-life practice of 'healing' for cancer in the community as perceived by clients and healers was investigated in a multi-method pilot study. Fifteen clients received six weekly healing sessions. Pre- and post-changes in perception towards well-being and client experience were assessed by EuroQol (EQ-5D), measure yourself concerns and well-being (MYCaW) and a client satisfaction tool. Qualitative methods, including focus groups, explored the perceived effects of healing in more depth and the participants' experience of taking part in research. The study was not designed to test the effect of healing on disease. Quantitative data showed perceived significant improvements in 'concerns/problems' for which clients wanted help (p<0.01), well-being (p<0.01) and anxiety/depression (p<0.05) over the course of healing. Significant effects were not seen in all areas of quality of life. Qualitative analysis showed clients mainly sought help for psychological and emotional concerns and reported only beneficial effects of healing. Clients attributed many of the quantitative improvements to healing itself. Despite some concerns, healers and clients engaged fully with the research process, and were enthusiastic about the importance of research into healing. Our study suggests that, while there are some confounding issues and study limitations to address, clients and healers perceive healing to have a range of benefits, particularly in terms of coping with cancer, and regard it as a useful approach that can be applied in a community setting alongside conventional medicine.

  2. A home-based physical activity intervention using activity trackers in survivors of childhood cancer: A pilot study.

    PubMed

    Le, Alyssa; Mitchell, Hannah-Rose; Zheng, Daniel J; Rotatori, Jaime; Fahey, John T; Ness, Kirsten K; Kadan-Lottick, Nina S

    2017-02-01

    Over 70% of childhood cancer survivors develop late complications from therapy, many of which can be mitigated by physical activity. Survivors engage in exercise at similar or lower rates than their sedentary healthy peers. We piloted a novel home-based exercise intervention with a motivational activity tracker. We evaluated (i) feasibility, (ii) impact on activity levels and physical fitness, and (iii) barriers, preferences, and beliefs regarding physical activity. Childhood cancer survivors currently 15 years or older and not meeting the Centers for Disease Control and Prevention physical activity guidelines were enrolled and instructed to wear the Fitbit One, a 4.8 cm × 1.8 cm motivational activity tracker, daily for 6 months. Baseline and follow-up evaluations included self-report surveys, an Actigraph accelerometer for 7 days, and a VO2 maximum test by cardiac stress test. Nineteen participants were enrolled (13.4% participation rate) with a mean age of 24.3 ± 5.8 years (range 15-35). Four participants withdrew with a 79% retention rate. Participants wore the Fitbit an average of 19.0 ± 4.7 days per month during months 1-3 and 15.0 ± 7.9 days per month during months 4-6. Total weekly moderate to vigorous physical activity increased from 265.6 ± 117.0 to 301.4 ± 135.4 min and VO2 maximum increased from 25.7 ± 7.7 to 27.2 ± 7.4 ml/kg/min. These changes were not statistically significant (P = 0.47 and 0.30, respectively). Survey responses indicated no change in barriers, preferences, and beliefs regarding physical activity. This pilot study of a motivational activity tracker demonstrated feasibility as measured by participant retention, receptivity, and belief of utility. Future studies with a large sample size are needed to demonstrate the efficacy and sustainability of this intervention. © 2016 Wiley Periodicals, Inc.

  3. Comparing Self-Injection Teaching Strategies for Patients With Breast Cancer and Their Caregivers: A Pilot Study.

    PubMed

    Fischer-Cartlidge, Erica; Romanoff, Sonya; Thom, Bridgette; Burrows Walters, Chasity

    2016-10-01

    A prospective, quasiexperimental pilot study with a sequential design was performed to compare two methods of teaching self-injection. The study examined 50 patients with breast cancer undergoing adjuvant or neoadjuvant treatment and their caregivers to determine if simulation during the teaching experience affects patient/caregiver satisfaction, worry, and self-confidence, as well as nurse satisfaction. Structured questionnaires were administered before the teaching, immediately after the teaching, and after the injection was performed at home. Nurses who performed the teaching also completed a questionnaire after the teaching. Use of simulation did not affect patient/caregiver satisfaction, worry, or self-confidence. The largest impact on learner worry was the actual teaching experience, regardless of the methodology used. Nurses reported greater levels of satisfaction when simulation was part of the teaching. Patient/caregiver satisfaction with the teaching experience decreased after performing the injection at home. Additional research is needed to identify the best methodology for teaching patients and caregivers self-injection. Data from this study revealed that the addition of simulation during teaching does not always translate to better education. In addition, based on patient/caregiver reports, no substitution exists for actual injection administration.

  4. Perioperative administration of propranolol to women undergoing ovarian cancer surgery: A pilot study

    PubMed Central

    Jang, Hye-In; Lim, Soo-Hyun; Lee, Yoo-Young; Kim, Tae-Joong; Lee, Jeong-Won; Kim, Byoung-Gie; Bae, Duk-Soo

    2017-01-01

    Objective This study was done to evaluate whether perioperative propranolol (ß-blocker) in ovarian cancer patients undergoing debulking surgery reduced perioperative tumor growth induced by surgical stress. Methods This was a prospective randomized single institution analysis. The primary objective was to compare the changes in CA 125 level (changes between preoperation day 2 and postoperative day 7). As a study arm, patients received a low dose of propranolol 40 mg/day (4×10 mg) starting two days before surgery and 40 mg twice daily for three days following surgery. Results Twenty-two patients were enrolled and 16 were evaluable for efficacy. The drug was well tolerated. The mean decrease of CA 125 during the seven perioperative days was 83.1±8.9% in the propranolol group and 72.4±14.7% in the placebo group. The difference was statistically significant (P=0.044). The change of C-reactive protein, cortisol, and anxiety score (State-Trait Anxiety Inventory-X1) were not different between the two groups. Conclusion This preliminary result is the first to directly test the role of perioperative propranolol on tumor growth. Even with the small sample size and short term use of the drug, perioperative propranolol was effective in reducing tumor burden (as measured by CA 125) suggesting its potential benefits in decreasing perioperative tumor growth. PMID:28344958

  5. Fixed-dose-rate administration of gemcitabine in cancer-bearing cats: A pilot study.

    PubMed

    Garnett, Crystal L; Guerrero, Teri A; Rodriguez, Carlos O

    2016-11-01

    Gemcitabine is an antimetabolite chemotherapy agent with schedule-dependent metabolism and efficacy. The purpose of this study was to identify the fixed-dose-rate (FDR) of gemcitabine administration in cancer-bearing cats that achieved a target plasma concentration (TPC) of 10 to 20 μM. Fifteen client-owned cats received gemcitabine infusions administered at various FDR for 1 to 6 hours. Plasma gemcitabine and dFdU (2',2'-difluorodeoxyuridine), the major gemcitabine metabolite, were quantitated by high performance liquid chromatography. Cats treated with an FDR less than 2.5 mg/m(2) per minute failed to achieve TPC, whereas cats treated with an FDR of 10 mg/m(2) per minute quickly exceeded the target range. An FDR of 5 mg/m(2) per minute provided the longest duration of exposure without exceeding the upper limit of the TPC. Plasma dFdU concentration mirrored plasma gemcitabine concentrations. These data suggest that in order to maintain TPC of gemcitabine in cats the FDR lies between 2.5 and 5 mg/m(2) per minute. A Phase II study to evaluate efficacy and toxicity of this approach is underway.

  6. Perioperative administration of propranolol to women undergoing ovarian cancer surgery: A pilot study.

    PubMed

    Jang, Hye-In; Lim, Soo-Hyun; Lee, Yoo-Young; Kim, Tae-Joong; Choi, Chel Hun; Lee, Jeong-Won; Kim, Byoung-Gie; Bae, Duk-Soo

    2017-03-01

    This study was done to evaluate whether perioperative propranolol (ß-blocker) in ovarian cancer patients undergoing debulking surgery reduced perioperative tumor growth induced by surgical stress. This was a prospective randomized single institution analysis. The primary objective was to compare the changes in CA 125 level (changes between preoperation day 2 and postoperative day 7). As a study arm, patients received a low dose of propranolol 40 mg/day (4×10 mg) starting two days before surgery and 40 mg twice daily for three days following surgery. Twenty-two patients were enrolled and 16 were evaluable for efficacy. The drug was well tolerated. The mean decrease of CA 125 during the seven perioperative days was 83.1±8.9% in the propranolol group and 72.4±14.7% in the placebo group. The difference was statistically significant (P=0.044). The change of C-reactive protein, cortisol, and anxiety score (State-Trait Anxiety Inventory-X1) were not different between the two groups. This preliminary result is the first to directly test the role of perioperative propranolol on tumor growth. Even with the small sample size and short term use of the drug, perioperative propranolol was effective in reducing tumor burden (as measured by CA 125) suggesting its potential benefits in decreasing perioperative tumor growth.

  7. Fixed-dose-rate administration of gemcitabine in cancer-bearing cats: A pilot study

    PubMed Central

    Garnett, Crystal L.; Guerrero, Teri A.; Rodriguez, Carlos O.

    2016-01-01

    Gemcitabine is an antimetabolite chemotherapy agent with schedule-dependent metabolism and efficacy. The purpose of this study was to identify the fixed-dose-rate (FDR) of gemcitabine administration in cancer-bearing cats that achieved a target plasma concentration (TPC) of 10 to 20 μM. Fifteen client-owned cats received gemcitabine infusions administered at various FDR for 1 to 6 hours. Plasma gemcitabine and dFdU (2′,2′-difluorodeoxyuridine), the major gemcitabine metabolite, were quantitated by high performance liquid chromatography. Cats treated with an FDR less than 2.5 mg/m2 per minute failed to achieve TPC, whereas cats treated with an FDR of 10 mg/m2 per minute quickly exceeded the target range. An FDR of 5 mg/m2 per minute provided the longest duration of exposure without exceeding the upper limit of the TPC. Plasma dFdU concentration mirrored plasma gemcitabine concentrations. These data suggest that in order to maintain TPC of gemcitabine in cats the FDR lies between 2.5 and 5 mg/m2 per minute. A Phase II study to evaluate efficacy and toxicity of this approach is underway. PMID:27807377

  8. The St. Jude Cancer Education for Children Program Pilot Study: Determining the Knowledge Acquisition and Retention of 4th-Grade Students.

    PubMed

    Ayers, Katherine; Villalobos, Aubrey Van Kirk; Li, Zhenghong; Krasin, Matthew

    2016-03-01

    In 2006, St. Jude Children's Research Hospital began developing a school-based outreach program known as the St. Jude Cancer Education for Children Program (SJCECP). The program aimed to teach children about cancer and healthy habits that can prevent the formation of cancers into adulthood. During the 2010-2011 academic years, we conducted a pilot evaluation of the SJCECP curriculum, with the primary objective of evaluating the impact of the intervention on knowledge acquisition and retention among 4th-grade students participating in the program. Seven local schools and 481 students from the Memphis area participated in the program evaluation. The results of this study show that 4th-grade students are able to acquire gains in knowledge related to cells, cancer, and healthy living after receiving the SJCECP intervention. We conclude that the program can be a useful tool for improving knowledge of cancer concepts at the 4th-grade level.

  9. Pilot study of 68Ga-DOTA-F(ab')2-trastuzumab in patients with breast cancer.

    PubMed

    Beylergil, Volkan; Morris, Patrick G; Smith-Jones, Peter M; Modi, Shanu; Solit, David; Hudis, Clifford A; Lu, Yang; O'Donoghue, Joseph; Lyashchenko, Serge K; Carrasquillo, Jorge A; Larson, Steven M; Akhurst, Timothy J

    2013-12-01

    68Ga-1,4,7,10-Tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA)-F(ab')2-trastuzumab [68Ga-DOTA-F(ab')2-trastuzumab] has been developed at our institution as a positron imaging reagent for assessing human epidermal growth factor receptor 2 (HER2) expression status by in-vivo imaging. Initial studies on animals demonstrated promising results in the monitoring of treatment response to heat shock protein 90-targeted drugs that inhibit the client protein HER2. We report here our initial clinical experience in the assessment of the toxicity, pharmacokinetics, biodistribution, and dosimetry profile of 68Ga-DOTA-F(ab')2-trastuzumab with PET/computed tomography using a mean of 236 MBq/5 mg administered intravenously. A group of 16 women with breast cancer were enrolled in this study. The one patient who did not receive 68Ga-DOTA-F(ab')2-trastuzumab was excluded from analysis. Both HER2-negative (n=7) and HER2-positive (n=8) cases were studied. Among the latter, seven had undergone trastuzumab treatment previously and one had not. It was determined that 68Ga-DOTA-F(ab')2-trastuzumab was well tolerated, with a T½ of ≈ 3.6 ± 0.9 h; the critical organ was the kidney, with a mean dose of 0.383 cGy/37 MBq; and tumor targeting was seen in 4/8 patients with HER2-positive disease. The reagent is safe, and assessments through additional studies in a better-defined group of patients, using larger administered masses of antibodies, with a better immunoreactive fraction are needed.

  10. A pilot study into the therapeutic effects of music therapy at a cancer help center.

    PubMed

    Burns, S J; Harbuz, M S; Hucklebridge, F; Bunt, L

    2001-01-01

    Since the mid-1980s, music therapy has been a regular feature of the residential program at the internationally renowned Bristol Cancer Help Centre, United Kingdom. Music therapy complements other therapeutic interventions available to residents at the center. To compare the therapeutic effects of listening to music in a relaxed state with the active involvement of music improvisation (the playing of tuned and untuned percussion instruments) in a music therapy group setting and to investigate the potential influence of music therapy on positive emotions and the immune system of cancer patients. A quantitative pre-posttest, psychological/physiological measures, and qualitative focus group design. A cancer help center that offers a fully integrated range of complementary therapies, psychological support, spiritual healing, and nutritional and self-help techniques addressing the physical, mental, emotional, and spiritual needs of cancer patients and their supporters. Twenty-nine cancer patients, aged 21 to 68 years. Group music therapy interventions of listening to recorded/live music in a relaxed state and improvisation. Increased well-being and relaxation and less tension during the listening experience. Increased well-being and energy and less tension during improvisation. Increased levels of salivary immunoglobulin A and decreased levels of cortisol in both experiences. Psychological data showed increased well-being and relaxation as well as altered energy levels in both interventions. Physiological data showed increased salivary immunoglobulin A in the listening experience and a decrease in cortisol levels in both interventions over a 2-day period. Preliminary evidence of a link between positive emotions and the immune system of cancer patients was found. These findings, which link listening to music in a relaxed state and improvisation to alterations in psychological and physiological parameters, may provide a better understanding of the effectiveness of music

  11. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.

    1991-12-06

    The objective of this project is to perform a microbial enhanced oil recovery field pilot test in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate-reducing bacteria will be stimulated to selectively plug flow paths which have been preferentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. During this quarter an additional tracer study was performed in the field to determine pre-treatment flow paths and the first nutrients were injected. 2 figs.

  12. Photodynamic therapy of nonmelanoma skin cancer with topical hypericum perforatum extract--a pilot study.

    PubMed

    Kacerovská, Denisa; Pizinger, Karel; Majer, Filip; Smíd, Frantisek

    2008-01-01

    Hypericin, the photoactive compound of Hypericum perforatum, is probably the most powerful photosensitizer found in nature. This compound has shown high potency in the photodynamic treatment of tumor cells. However, there is only limited knowledge regarding the photodynamic effect of hypericin on nonmelanoma skin cancer cells. The aim of this prospective study was to investigate the efficacy of photodynamic therapy with topical application of an extract of H. perforatum in actinic keratosis, basal cell carcinoma (BCC) and morbus Bowen (carcinoma in situ). The study was carried out on 34 patients--eight with actinic keratoses (AKs), 21 with BCC and five with Bowen's disease. The extract of H. perforatum was applied on the skin lesions under occlusion and that was followed by irradiation with 75 J cm(-2) of red light 2 h later. The treatment was performed weekly for 6 weeks on average. The percentage of complete clinical response was 50% for AKs, 28% in patients with superficial BCC and 40% in patients with Bowen's disease. There was only a partial remission seen in patients with nodular BCCs. A complete disappearance of tumor cells was found in the histologic preparation of 11% of patients with superficial BCCs and 80% in the patients with Bowen's disease. All patients complained of burning and pain sensations during irradiation. Although the results of this first clinical trial could be regarded as disappointing, there are still possibilities for improvement. Better preparation of the lesions, enhancement of hypericin delivery and other types of light exposure procedures could significantly improve the clinical outcomes of this relatively inexpensive treatment modality.

  13. Interest of sentinel node biopsy in apparently intrathyroidal medullary thyroid cancer: a pilot study.

    PubMed

    Puccini, M; Manca, G; Ugolini, C; Candalise, V; Passaretti, A; Bernardini, J; Boni, G; Buccianti, P

    2014-09-01

    Initial surgery for medullary thyroid cancer (MTC) with no evidence of lymph node involvement in neck compartments consists of total thyroidectomy and prophylactic central neck dissection. This study evaluated the reliability of a radiotracer technique for the intraoperative detection of sentinel lymph nodes (SLNs) in lateral compartments in patients with early MTC. Patients with limited (cT1 N0) MTC entered the study (2009-2012). A 0.1-0.3 ml suspension of macrocolloidal technetium-99-labeled human albumin was injected (under echo-guide) in the tumor 5 h before surgery. Preoperative lymphoscintigraphy confirmed the identification of SLNs in the lateral neck. The operation consisted of total thyroidectomy and central neck dissection, and a hand-held gamma-probe (Neoprobe) guide was used to remove the SLNs from the lateral neck. Four patients were recruited. The tracer always indicated a SLN. Pathology reports indicated micrometastases from MTC in SLN in three patients. At a mean follow-up of 30.5 months, all patients were biochemically cured. The technique we describe to detect and remove neck SLN from MTC seemed to be very accurate. It always showed the SLNs (usually two) in the lateral compartments. Micrometastases were detected in three of four patients, allowing their correct staging. The method described here for the detection of SLNs in early MTC seems effective and reliable and can be used for a more precise N staging of the patients. It could play a role, alone or combined with other techniques, in driving the extent of prophylactic neck dissection or other potential applications.

  14. Microbial Field Pilot Study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1990-11-01

    This report covers progress made during the first year of the Microbial Field Pilot Study project. Information on reservoir ecology and characterization, facility and treatment design, core experiments, bacterial mobility, and mathematical modeling are addressed. To facilitate an understanding of the ecology of the target reservoir analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. A preliminary design of facilities for the operation of the field pilot test was prepared. In addition, procedures for facilities installation and for injection treatments are described. The Southeast Vassar Vertz Sand Unit (SEVVSU), the site of the proposed field pilot study, is described physically, historically, and geologically. The fields current status is presented and the ongoing reservoir simulation is discussed. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. Two possible mechanisms, relative permeability effects and changes in the capillary number, are discussed and related to four Berea core experiments' results. The experiments were conducted at reservoir temperature using SEVVSU oil, brine, and bacteria. The movement and activity of bacteria in porous media were investigated by monitoring the growth of bacteria in sandpack cores under no flow conditions. The rate of bacteria advancement through the cores was determined. A mathematical model of the MEOR process has been developed. The model is a three phase, seven species, one dimensional model. Finite difference methods are used for solution. Advection terms in balance equations are represented with a third- order upwind differencing scheme to reduce numerical dispersion and oscillations. The model is applied to a batch fermentation example. 52 refs., 26 figs., 21 tabs.

  15. Surgical nurses' attitudes towards caring for patients dying of cancer - a pilot study of an educational intervention on existential issues.

    PubMed

    Udo, C; Melin-Johansson, C; Henoch, I; Axelsson, B; Danielson, E

    2014-07-01

    This is a randomised controlled pilot study using a mixed methods design. The overall aim was to test an educational intervention on existential issues and to describe surgical nurses' perceived attitudes towards caring for patients dying of cancer. Specific aims were to examine whether the educational intervention consisting of lectures and reflective discussions, affects nurses' perceived confidence in communication and to explore nurses' experiences and reflections on existential issues after participating in the intervention. Forty-two nurses from three surgical wards at one hospital were randomly assigned to an intervention or control group. Nurses in both groups completed a questionnaire at equivalent time intervals: at baseline before the educational intervention, directly after the intervention, and 3 and 6 months later. Eleven face-to-face interviews were conducted with nurses directly after the intervention and 6 months later. Significant short-term and long-term changes were reported. Main results concerned the significant long-term effects regarding nurses' increased confidence and decreased powerlessness in communication, and their increased feelings of value when caring for a dying patient. In addition, nurses described enhanced awareness and increased reflection. Results indicate that an understanding of the patient's situation, derived from enhanced awareness and increased reflection, precedes changes in attitudes towards communication. © 2014 John Wiley & Sons Ltd.

  16. Image and pathological changes after microwave ablation of breast cancer: a pilot study.

    PubMed

    Zhou, Wenbin; Jiang, Yanni; Chen, Lin; Ling, Lijun; Liang, Mengdi; Pan, Hong; Wang, Siqi; Ding, Qiang; Liu, Xiaoan; Wang, Shui

    2014-10-01

    To prospectively assess MR imaging evaluation of the ablation zone and pathological changes after microwave ablation (MWA) in breast cancer. Twelve enrolled patients, diagnosed with non-operable locally advanced breast cancer (LABC), were treated by MWA and then neoadjuvant chemotherapy, followed by surgery. MR imaging was applied to evaluate the effect of MWA. Hematoxylin-eosin (HE) staining and transmission electron microscopy (TEM) were applied to analyze the ablated area. All MWA procedures were performed successfully under local anesthesia. For a mean duration of 2.15 min, the mean largest, middle and smallest diameters in the ablated zone 24-h post-ablation in MR imaging were 2.98 cm ± 0.53, 2.51 cm ± 0.41 and 2.23 cm ± 0.41, respectively. The general shape of the ablation zone was close to a sphere. The ablated area became gradually smaller in MR imaging. No adverse effects related to MWA were noted in all 12 patients during and after MWA. HE staining could confirm the effect about 3 months after MWA, which was confirmed by TEM. 2 min MWA can cause an ablation zone with three diameters larger than 2 cm in breast cancer, which may be suitable for the local treatment of breast cancer up to 2 cm in largest diameter. However, the long-term effect of MWA in the treatment of small breast cancer should be determined in the future. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Pilot study of the early start of chemotherapy after resection of primary colorectal cancer with distant metastases (Pearl Star 01).

    PubMed

    Yoshida, Yoichiro; Hoshino, Seiichiro; Aisu, Naoya; Naito, Masayasu; Miyake, Toru; Tanimura, Syu; Yamashita, Yuichi

    2013-02-07

    The start of chemotherapy usually requires a delay of about 4 weeks after surgical resection of colorectal cancer. However, there is no evidence for the required length of this delay interval. In addition, there is a chance that a patient may die because postoperative chemotherapy was not started soon enough and a metastatic tumor was able to develop rapidly. We therefore conducted a pilot study to determine the safety and feasibility of an early start of chemotherapy after the resection of colorectal cancer with distant metastases. Five patients were enrolled. They received XELOX therapy (130 mg/m2 of oxaliplatin on day 1 plus 1,000 mg/m2 of capecitabine twice daily on days 1 to 14) on the 7th postoperative day and XELOX + bevacizumab (7.5 mg/kg of bevacizumab on day 1) after the 2nd cycle of chemotherapy. Five patients underwent open surgery. The procedures included right hemicolectomy in 1 patient, sigmoidectomy in 2 patients, high anterior resection in 1 patient, and Hartmann procedure in 1 patient. All patients started chemotherapy on postoperative day 7. The median number of cycles of chemotherapy was 11 (8 to 22). No postoperative complications were observed. The tumor reduction rate was 44.3% (32.0 to 66.6%). Progression-free survival was 10.3 months. An early start of chemotherapy after surgery is feasible and safe. These findings suggest possible changes in the start time of chemotherapy after surgery in the future. We have already started a new phase II trial to confirm the effects of the early start of chemotherapy after surgery. UMIN000004361.

  18. Tai Chi effects on neuropsychological, emotional, and physical functioning following cancer treatment: a pilot study.

    PubMed

    Reid-Arndt, Stephanie A; Matsuda, Sandy; Cox, Cathy R

    2012-02-01

    To examine the effects of a 10-week Tai Chi (TC) program on neuropsychological, psychological, and physical health of female cancer survivors. Twenty-three women with a history of cancer participated in 60-min TC classes two times/week for 10-weeks. Before and after the intervention, participants completed neuropsychological tests (memory, executive functioning, language, and attention); 5 tests of balance; and self-report questionnaires of neuropsychological complaints, stress and mood, and fatigue. After the 10-week session, participants evidenced fewer neuropsychological complaints and enhanced neuropsychological functioning. They also demonstrated improved balance and reported better psychological functioning. Results suggest that TC may promote gains in neuropsychological functioning, in addition to previously demonstrated improvements in physical and psychological health. These findings support the need for controlled trials examining the potential benefits of TC on neuropsychological functioning after cancer. Copyright © 2011 Elsevier Ltd. All rights reserved.

  19. EGFR and KRAS mutations in Turkish non-small cell lung cancer patients: a pilot study.

    PubMed

    Bircan, Sema; Baloglu, Huseyin; Kucukodaci, Zafer; Bircan, Ahmet

    2014-08-01

    EGFR and KRAS mutation profile in non-small cell lung cancers (NSCLCs) shows wide variations due to geographic and ethnic background. We aimed to determine the frequency and types of EGFR and KRAS mutations in a sample group of Turkish NSCLC cases. The study included 14 adenocarcinomas (ACs), 11 squamous cell carcinoma (SCC) patients selected from archival material including small biopsy or surgical specimens. Their formalin fixed paraffin-embedded tumor tissues were used for genomic DNA extraction for EGFR exon 19 and 21, and KRAS exon 2 mutations. Eleven NSCLCs (44 %) had EGFR mutations. Exon 19 and 21 mutations were found in 8 (32 %) and 5 (20 %) cases. Two cases showed double EGFR mutations. In ACs, 5 (35.7 %) patients had EGFR gene mutation, 3 in exon 19 and 3 in exon 21. In SCCs, 6 (54.5 %) cases had EGFR mutation, 5 in exon 19 and 2 in exon 21. All exon 19 mutations were deletion-type mutations. For exon 21, 3 cases had L858R point mutation (CTG>CGG) and two cases showed deletion-type mutations. Six (24 %) NSCLCs showed KRAS mutations (three ACC, three SCC), 5 codon 12 mutations (G>T, T>C, G>A) and one codon 13 mutation (G>T). Three NSCLC cases showed both EGFR and KRAS mutations together. The profile of KRAS mutation in our AC cases was quite similar to those seen in the Western countries; however, frequency and clustering of EGFR mutations were similar to those seen in the Eastern countries.

  20. Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF-Mutated Colorectal Cancer

    PubMed Central

    Kopetz, Scott; Desai, Jayesh; Chan, Emily; Hecht, Joel Randolph; O'Dwyer, Peter J.; Maru, Dipen; Morris, Van; Janku, Filip; Dasari, Arvind; Chung, Woonbook; Issa, Jean-Pierre J.; Gibbs, Peter; James, Brian; Powis, Garth; Nolop, Keith B.; Bhattacharya, Suman; Saltz, Leonard

    2015-01-01

    Purpose BRAF V600E mutation is seen in 5% to 8% of patients with metastatic colorectal cancer (CRC) and is associated with poor prognosis. Vemurafenib, an oral BRAF V600 inhibitor, has pronounced activity in patients with metastatic melanoma, but its activity in patients with BRAF V600E–positive metastatic CRC was unknown. Patients and Methods In this multi-institutional, open-label study, patients with metastatic CRC with BRAF V600 mutations were recruited to an expansion cohort at the previously determined maximum-tolerated dose of 960 mg orally twice a day. Results Twenty-one patients were enrolled, of whom 20 had received at least one prior metastatic chemotherapy regimen. Grade 3 toxicities included keratoacanthomas, rash, fatigue, and arthralgia. Of the 21 patients treated, one patient had a confirmed partial response (5%; 95% CI, 1% to 24%) and seven other patients had stable disease by RECIST criteria. Median progression-free survival was 2.1 months. Patterns of concurrent mutations, microsatellite instability status, CpG island methylation status, PTEN loss, EGFR expression, and copy number alterations were not associated with clinical benefit. In contrast to prior expectations, concurrent KRAS and NRAS mutations were detected at low allele frequency in a subset of the patients' tumors (median, 0.21% allele frequency) and were apparent mechanisms of acquired resistance in vemurafenib-sensitive patient-derived xenograft models. Conclusion In marked contrast to the results seen in patients with BRAF V600E–mutant melanoma, single-agent vemurafenib did not show meaningful clinical activity in patients with BRAF V600E mutant CRC. Combination strategies are now under development and may be informed by the presence of intratumor heterogeneity of KRAS and NRAS mutations. PMID:26460303

  1. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year`s report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  2. Microbial field pilot study

    SciTech Connect

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year's report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  3. Smartphone Use for Cervical Cancer Screening in Low-Resource Countries: A Pilot Study Conducted in Madagascar

    PubMed Central

    Catarino, Rosa; Vassilakos, Pierre; Scaringella, Stefano; Undurraga-Malinverno, Manuela; Meyer-Hamme, Ulrike; Ricard-Gauthier, Dominique; Matute, Juan Carlos; Petignat, Patrick

    2015-01-01

    Background Visual inspection of the cervix after application of 5% acetic acid (VIA) is a screening technique for cervical cancer used widely in low and middle-income countries (LMIC). To improve VIA screening performance, digital images after acid acetic application (D-VIA) are taken. The aim of this study was to evaluate the use of a smartphone for on- and off-site D-VIA diagnosis. Materials and Methods Women aged 30–65 years, living in the city of Ambanja, Madagascar, were recruited through a cervical cancer screening campaign. Each performed a human papillomavirus (HPV) self-sample as a primary screen. Women testing positive for HPV were referred for VIA followed by D-VIA, cervical biopsy and endocervical curettage according to routine protocol. In addition, the same day, the D-VIA was emailed to a tertiary care center for immediate assessment. Results were scored as either D-VIA normal or D-VIA abnormal, requiring immediate therapy or referral to a tertiary center. Each of the three off-site physicians were blinded to the result reported by the one on-site physician and each gave their individual assessment followed by a consensus diagnosis. Statistical analyses were conducted using STATA software. Results Of the 332 women recruited, 137 (41.2%) were HPV-positive and recalled for VIA triage; compliance with this invitation was 69.3% (n = 95). Cervical intraepithelial neoplasia was detected in 17.7% and 21.7% of digital images by on-site and off-site physicians, respectively. The on-site physician had a sensitivity of 66.7% (95%CI: 30.0–90.3) and a specificity of 85.7% (95%CI: 76.7–91.6); the off-site physician consensus sensitivity was 66.7% (95%CI: 30.0–90.3) with a specificity of 82.3% (95%CI: 72.4–89.1). Conclusion This pilot study supports the use of telemedicine for off-site diagnosis of cervical intraepithelial neoplasia, with diagnostic performance similar to those achieved on-site. Further studies need to determine if smartphones can improve

  4. Evaluation of Human Papilloma Virus Communicative Education Strategies: A Pilot Screening Study for Cervical Cancer

    ERIC Educational Resources Information Center

    Barrera-Clavijo, Lizeth K.; Wiesner-Ceballos, Carolina; Rincón-Martínez, Lina M.

    2016-01-01

    Background: High-risk human papilloma virus (HR-HPV) is highly prevalent in sexually active men and women; HR-HPV has been classified as a sexually transmitted infection (STI) and as a necessary, but not sufficient, causal agent for cervical cancer. Women who test positive for HPV often experience serious psychosocial consequences such as fear,…

  5. Communicating breast cancer risk information to young adult women: A pilot study.

    PubMed

    Bernat, Jennifer K; Hullmann, Stephanie E; Sparks, Glenn G

    2017-01-01

    To examine the effectiveness of a health promotion flyer to increase awareness of breast cancer risk and physical activity as a risk reduction strategy in young adult women. Young adult women (N = 123) viewed one of five health promotion flyers online and then completed measures of perceived breast cancer risk (PR) and perceived informativeness (PI) and a qualitative thought-listing activity. Differences were observed in PI such that the control and low risk/low information messages were significantly less informative than the others. Qualitative analyses revealed two general themes: message content and flyer design. Additional analyses of the flyer design comments revealed four sub-themes: negative thoughts about the image, positive thoughts about the image, misunderstanding breast cancer risk information, and social comparison. Exploratory analyses controlling for message type indicated that image appraisal predicted PI such that those who commented on the image found the flyer to be less informative. Results suggest that the flyer was informative but did not impact young women's breast cancer risk perceptions. Additionally, the image may have distracted young women from the intended message. Evaluating the acceptability of images used in health promotion materials is recommended before testing the effectiveness of the intervention.

  6. Evaluation of Human Papilloma Virus Communicative Education Strategies: A Pilot Screening Study for Cervical Cancer

    ERIC Educational Resources Information Center

    Barrera-Clavijo, Lizeth K.; Wiesner-Ceballos, Carolina; Rincón-Martínez, Lina M.

    2016-01-01

    Background: High-risk human papilloma virus (HR-HPV) is highly prevalent in sexually active men and women; HR-HPV has been classified as a sexually transmitted infection (STI) and as a necessary, but not sufficient, causal agent for cervical cancer. Women who test positive for HPV often experience serious psychosocial consequences such as fear,…

  7. Genetic Counseling for Hereditary Cancer: A Pilot Study on Experiences of Patients and Family Members.

    ERIC Educational Resources Information Center

    Bleiker, E. M. A.; Aaronson, N. K.; Menko, F. H.; Hahn, D. E. E.; van Asperen, C. J.; Rutgers, E. J. T.; ten Kate, L. P.; Leschot, N. J.

    1997-01-01

    Individuals who received genetic counseling for cancer (N=36) provided feedback on the quality of services and identified areas for improvement. Reasons for counseling and need for psychosocial support are also considered. Generally high levels of satisfaction with care provided were found. Four areas for improvement are identified and discussed.…

  8. Prevalence of silent breast cancer in autopsy specimens, as studied by the disease being held by image-guided biopsies: The pilot study and literature review

    PubMed Central

    Sidiropoulou, Zacharoula; Vasconcelos, Ana Paula; Couceiro, Cristiana; Dos Santos, Carlos; Araújo, Ana Virginia; Alegre, Inês; Santos, Claudia; Costa, Filipa; Henriques, Vanessa; Neves, Carlos; Cardoso, Fátima; Gascon, Pere

    2017-01-01

    Breast cancer epidemiological patterns vary in European countries, which present different incidence rates. Data have suggested that the reduction in breast cancer mortality is not only due to the early detection of the disease, but is, in almost equal part, due to screening and to the advances that have been made in molecular medicine and the development of novel therapies. The aim of the present study is to quantify the actual number of cases of breast cancer present in both of the sexes by calculating the prevalence of silent breast cancer in corpses. To achieve this quantification, bilateral subcutaneous radical mastectomies are performed in corpses of either sex above 40 years of age that lacked any clinical manifestation of the disease, and where the breast cancer or its complications was not the cause of death. Only five publications exist in the international literature based on medico-legal autopsies that were designed to define the ‘natural reservoir’ of the disease. To the best of our knowledge, the present study is the first one to appraise breast tissue via imaging by means of orienting the biopsy incision. In conclusion, to the best of our knowledge, the design of the present study is the first of its type, where image-guided biopsies are used to define the prevalence of silent breast cancer. The study aims to demonstrate that the ‘disease reservoir’ is, in reality, higher than was originally considered to be so. Furthermore, the study aims to contribute towards an improved definition of the disease by determining which tumour profiles potentially do not benefit from aggressive treatments (for example, in case where a high prevalence of low-grade ductal carcinoma in situ is to be detected). According to our pilot study, this analysis represents a feasible protocol. PMID:28781784

  9. 'Act on oncology' as a new comprehensive approach to assess prostate cancer centres--method description and results of a pilot study.

    PubMed

    Voigt, Wieland; Hoellthaler, Josef; Magnani, Tiziana; Corrao, Vito; Valdagni, Riccardo

    2014-01-01

    Multidisciplinary care of prostate cancer is increasingly offered in specialised cancer centres. It requires the optimisation of medical and operational processes and the integration of the different medical and non-medical stakeholders. To develop a standardised operational process assessment tool basing on the capability maturity model integration (CMMI) able to implement multidisciplinary care and improve process quality and efficiency. Information for model development was derived from medical experts, clinical guidelines, best practice elements of renowned cancer centres, and scientific literature. Data were organised in a hierarchically structured model, consisting of 5 categories, 30 key process areas, 172 requirements, and more than 1500 criteria. Compliance with requirements was assessed through structured on-site surveys covering all relevant clinical and management processes. Comparison with best practice standards allowed to recommend improvements. 'Act On Oncology'(AoO) was applied in a pilot study on a prostate cancer unit in Europe. Several best practice elements such as multidisciplinary clinics or advanced organisational measures for patient scheduling were observed. Substantial opportunities were found in other areas such as centre management and infrastructure. As first improvements the evaluated centre administration described and formalised the organisation of the prostate cancer unit with defined personnel assignments and clinical activities and a formal agreement is being worked on to have structured access to First-Aid Posts. In the pilot study, the AoO approach was feasible to identify opportunities for process improvements. Measures were derived that might increase the operational process quality and efficiency.

  10. Pilot Field Test Study

    NASA Technical Reports Server (NTRS)

    Sherriff, Abigail

    2015-01-01

    The Field Test study is currently in full swing, preceded by the successful completion of the Pilot Field Test study that paved the way for collecting data on the astronauts in the medical tent in Kazakhstan. Abigail Sherriff worked alongside Logan Dobbe on one Field Test aspect to determine foot clearance over obstacles (5cm, 10cm, and 15cm) using APDM Inc. Internal Measurement Units (IMU) worn by the astronauts. They created a program to accurately calculate foot clearance using the accelerometer, magnetometer, and gyroscope data with the IMUs attached to the top of the shoes. To validate the functionality of their program, they completed a successful study on test subjects performing various tasks in an optical motion studio, considered a gold standard in biomechanics research. Future work will include further validation and expanding the program to include other analyses.

  11. Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators.

    PubMed

    Postmus, D; Mavris, M; Hillege, H L; Salmonson, T; Ryll, B; Plate, A; Moulon, I; Eichler, H-G; Bere, N; Pignatti, F

    2016-05-01

    Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and methodology for such studies have not been agreed upon. The European Medicines Agency (EMA) conducted a pilot study to gain experience on how the collection of individual preferences can inform the regulatory review. Using a short online questionnaire, ordinal statements regarding the desirability of different outcomes in the treatment of advanced cancer were elicited from 139 participants (98 regulators, 29 patient or carers, and 12 healthcare professionals). This was followed by face-to-face meetings to gather feedback and validate the individual responses. In this article we summarize the EMA pilot study and discuss the role of patient preference studies within the regulatory review. Based on the results, we conclude that our preference elicitation instrument was easy to implement and sufficiently precise to learn about the distribution of the participants' individual preferences. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  12. Clinical application of spectral electromagnetic interaction in breast cancer: diagnostic results of a pilot study.

    PubMed

    De Cicco, Concetta; Mariani, Luigi; Vedruccio, Clarbruno; Ricci, Carla; Balma, Massimo; Rotmensz, Nicole; Ferrari, Mahila Esmeralda; Autino, Elena; Trifirò, Giuseppe; Sacchini, Virgilio; Viale, Giuseppe; Paganelli, Giovanni

    2006-01-01

    There is a need for a cost-effective method to safely reduce the number of diagnostic procedures women undergo for breast cancer. We tested a new procedure for breast cancer diagnosis based on breast tissue response to low level electromagnetic incident waves. We tested 101 patients with suspicious palpable breast lesions detected by mammography or ultrasonography, who were scheduled to undergo an open biopsy. Using an electromagnetic field generator (tissue resonance interaction method probe [TRIMprob]), we passed the TRIMprob over the breast area and recorded the signal variation of one or more spectral lines (dB1, dB2, dB3). The results were compared with those of a control group as well as with pathology data obtained from excisional biopsy. No adverse effects of the test were observed. Pathology revealed 86 malignant breast cancers (72 invasive, 14 in situ) and 15 benign conditions. We achieved the best discrimination between normal breasts and lesions using dB1 (dB1 AUC-ROC = 0.8; dB2 AUC-ROC = 0.61; dB3 AUC-ROC = 0.76). With a specificity of 75% to 95%, the sensitivity ranged from 49% to 84%. Tumor or patient variables did not influence the results. The TRIMprob test was able to provide some degree of discrimination between normal breast tissue and lesions but not between benign and malignant lesions. The lack of influence of patient age and tumor size on test results might be advantageous in terms of early diagnosis in young women. These preliminary results need to be verified and extended in a preclinical-stage disease setting before clinical applicability can be envisaged.

  13. Patient-reported symptoms of radiation dermatitis during breast cancer radiotherapy: a pilot study.

    PubMed

    Lee, Jieun; Park, Won; Choi, Doo Ho; Huh, Seung Jae; Kim, Im-Ryung; Kang, Danbee; Cho, Juhee

    2017-07-01

    To find out which symptoms most frequently and severely affect breast cancer patients during radiotherapy and how patients manage the symptoms and unmet needs. A cross-sectional survey was conducted with 111 patients who receive radiotherapy for breast cancer from January to April 2015 at Samsung Medical Center in Seoul, South Korea. Participants were asked about symptoms and discomfort due to radiotherapy, management methods for radiation dermatitis, unmet needs for radiation dermatitis care, and clinical and socio-demographic information. Of total, 108 out of 111 patients (97.3%) reported symptoms related to radiation dermatitis. Hyperpigmentation was the most commonly reported uncomfortable symptom followed by erythema. On average, patients reported 8.6 radiotherapy-induced skin problems (range, 0-11). Of total, 59 (53.2%) patients stated that they wanted care for radiation dermatitis, and 80.0, 59.4, and 51% of patients searched for information, used products, and visited the hospital to manage radiotherapy-related skin problems. Patients who experienced dryness, burning feelings, irritation, roughness, and hyperpigmentation were 11.73, 7.02, 5.10, 4.27, and 2.80 times more likely to have management needs than patients without those symptoms, respectively, adjusting age, current cycle of radiation therapy, chemotherapy, and type of surgery. Most of the breast cancer patients experience multiple symptoms associated with radiation dermatitis. Hyperpigmentation was the most common and uncomfortable symptom followed by erythema. Majority of patients wanted management for radiation dermatitis and patients who experienced dryness, burning feelings, irritation, roughness, and hyperpigmentation had higher needs for radiation dermatitis management.

  14. Attitudes toward cervical cancer screening among Muslim women: a pilot study.

    PubMed

    Matin, Mina; LeBaron, Samuel

    2004-01-01

    Immigrant Muslim women have low rates of health care utilization, especially preventive care such as breast exams, mammograms, and cervical cancer screening. Religious and cultural beliefs, such as the value placed on modesty and premarital virginity, contribute to reluctance to seek health care. In addition, it has been unclear whether discussions of health care behavior that involve sexuality and reproductive health would be welcomed among immigrant Muslim women. (1) To examine the impact of religious and cultural values on health care behavior of Muslim women from immigrant backgrounds in the San Francisco Bay Area, particularly with regard to cervical cancer screening; (2) To determine whether these women would welcome discussing values and beliefs regarding sexuality and reproductive health. Our key informants were five Muslim women who identified pelvic and Pap smear screening exams as major sources of anxiety for their community, and therefore major barriers to health care. Three focus groups were then convened, including 15 women ages 18-25, to discuss these issues in more detail. Many Muslim women from immigrant backgrounds face challenges in obtaining adequate health care due to some common barriers of language, transportation, insurance, and family pressures. Additionally, many Muslim women resist screening practices that are the standard in the US but which threaten their cultural and religious values. Equally important, many health care professionals contribute to the women's challenges by making inappropriate recommendations regarding physical exams and reproductive health. The women were enthusiastic and candid in discussing these highly sensitive and taboo topics.

  15. Single-site robotic surgery in gynecologic cancer: a pilot study

    PubMed Central

    Yoo, Ha-Na; Lee, Yoo-Young; Choi, Chel Hun; Lee, Jeong-Won; Bae, Duk-Soo; Kim, Byoung-Gie

    2015-01-01

    Objective To discuss the feasibility of single-site robotic surgery for benign gynecologic tumors and early stage gynecologic cancers. Methods In this single institution, prospective analysis, we analyzed six patients who had undergone single-site robotic surgery between December 2013 and August 2014. Surgery was performed using the da Vinci Si Surgical System. Patient characteristics and surgical outcomes were analyzed. Results Single-site robotic surgery was performed successfully in all six cases. The median patient age was 48 years, and the median body mass index was 25.5 kg/m2 (range, 22 to 33 kg/m2). The median total operative time was 211 minutes, and the median duration of intracorporeal vaginal cuff suturing was 32 minutes (range, 22 to 47 minutes). The median duration of pelvic lymph node dissection was 31 minutes on one side and 27 minutes on the other side. Patients' postoperative courses were uneventful. The median postoperative hospital stay was 4 days. No postoperative complications occurred. Conclusion When used to treat benign gynecologic tumors and early stage gynecologic cancers, the single-site da Vinci robotic surgery is feasible, safe, and produces favorable surgical outcomes. PMID:25609162

  16. Feasibility of intraoperative radiation therapy for early breast cancer in Japan: a single-center pilot study and literature review.

    PubMed

    Sawaki, Masataka; Kondo, Naoto; Horio, Akiyo; Ushio, Aya; Gondo, Naomi; Adachi, Eri; Hattori, Masaya; Fujita, Takashi; Tachibana, Hiroyuki; Kodaira, Takeshi; Iwata, Hiroji

    2014-07-01

    Intraoperative radiation therapy (IORT) is under evaluation in breast-conserving surgery because the feasibility of the IORT procedure including transportation of the patient under general anesthesia is not well established. Thus, this prospective single-center study aimed to test the feasibility of IORT at a single dose of 21 Gy in Japanese breast cancer patients. The primary endpoint was early toxicity; the secondary endpoint was late toxicity. Patients with histologically or cytologically proven primary early breast cancer were eligible. Inclusion criteria were as follows: (1) T < 2.5 cm; (2) desire for breast-conserving surgery; (3) age >50 years; (4) surgical margin >1 cm; (5) intraoperative pathologically free margins; and (6) sentinel node negative. Exclusion criteria were (1) contraindications to radiation therapy; (2) past radiation therapy for the same breast or chest; (3) extensive intraductal component; and (4) a tumor located in the axillary tail of the breast. All patients gave written informed consent. Partial resection was performed with at least a margin of 1 cm around the tumor. The patient was transported from the surgical suite to the radiation room. Radiation (Clinac(®) 21EX, Varian Medical Systems, Inc.) at 21 Gy was delivered directly to the mammary gland. Toxicity was evaluated with the Common Terminology Criteria for Adverse Events V4.0. Five patients were enrolled in this pilot study and received 21 Gy. Follow-up ranged from 7.8 to 11.0 months (median 10.2). Intraoperative transportation to the radiation room during the surgical procedure under general anesthesia was performed safely in all patients. Treatment-related toxicities within 3 months were deep connective tissue fibrosis (grade 1, n = 3) and pain (grade 1, n = 3). There was no case of wound infection, wound dehiscence, or soft tissue necrosis. Overall, there was no severe adverse event. The procedure was tolerated very well in this first group of Japanese female patients treated

  17. [Study of 5'-DFUR treatment as postoperative adjuvant chemotherapy for stomach and colorectal cancer. Tokai GATS Group (pilot study)].

    PubMed

    Yamaguchi, A; Maeda, A; Hachisuka, K; Yura, J; Honda, K; Honda, H; Yoshizaki, S; Tsuruga, N; Nakazato, H

    1994-04-01

    In order to study preliminary the safety of 5'-DFUR treatment as postoperative adjuvant therapy, intermittent and continuous treatment regimens were administered to patients undergoing curative resection of carcinomas of the stomach and the colorectum. Two treatment schedules were employed: 5'-DFUR was either given continuously in a daily oral dose of 600 mg/patient (continuous group) or for 2 weeks in a daily oral dose of 1,200 mg/patient followed by 2 weeks of no treatment (intermittent group). Twenty-one stomach cancer patients and 34 colorectal cancer patients were registered in the study. The rates of adverse drug reactions in the patients who completed treatment were 20.0% (2/10) in the continuous group and 50.0% (4/8) in the intermittent group of gastric cancer patients, and 16.6% (2/12) in the continuous group and 17.6% (3/17) in the intermittent group of colorectal cancer patients. The main adverse drug reactions were gastrointestinal symptoms. The incidence of diarrhea, a problematic side effect of 5'-DFUR, was 4.5% (1/22) in the continuous group and 12.0% (3/25) in the intermittent group. There were no statistically significant differences between the continuous group and the intermittent group in regard to the incidence of adverse drug reactions and survival rate. In addition, as there were no serious adverse drug reactions, both treatment regimens were demonstrated to be highly safe when administered as postoperative adjuvant therapy.

  18. Defense Mechanisms and Utilization in Cancer Patients Undergoing Radiation Therapy: A Pilot Study.

    PubMed

    Porcerelli, John H; Cramer, Phebe; Porcerelli, Daniel J; Arterbery, V Elayne

    2017-06-01

    A group of 49 patients who had been diagnosed with cancer during the preceding year and who were receiving radiation therapy were assessed for their use of defense mechanisms, as well as for their level of psychological distress. In addition, their utilization of medical services was determined. It was predicted that the use of services that were under the patients' control-namely, requesting extra outpatient visits and making trips to the emergency department-would be related to the patients' use of defense mechanisms, whereas a treatment option not under the patients' control-overnight hospitalization based on physicians' assessment of condition-would not be related to defense use. The findings confirmed the hypotheses. Outpatient visits were strongly predicted by defense use, whereas hospitalization was determined by psychological distress. However, emergency department visits were determined by both defense use and psychological distress. In addition, an interaction between defense and distress was found to predict hospitalization.

  19. Targeted Androgen Pathway Suppression in Localized Prostate Cancer: A Pilot Study

    PubMed Central

    Mostaghel, Elahe A.; Nelson, Peter S.; Lange, Paul; Lin, Daniel W.; Taplin, Mary Ellen; Balk, Steven; Ellis, William; Kantoff, Philip; Marck, Brett; Tamae, Daniel; Matsumoto, Alvin M.; True, Lawrence D.; Vessella, Robert; Penning, Trevor; Hunter Merrill, Rachel; Gulati, Roman; Montgomery, Bruce

    2014-01-01

    Purpose Ligand-mediated activation of the androgen receptor (AR) is critical for prostate cancer (PCa) survival and proliferation. The failure to completely ablate tissue androgens may limit suppression of PCa growth. We evaluated combinations of CYP17A and 5-α-reductase inhibitors for reducing prostate androgen levels, AR signaling, and PCa volumes. Patients and Methods Thirty-five men with intermediate/high-risk clinically localized PCa were randomly assigned to goserelin combined with dutasteride (ZD), bicalutamide and dutasteride (ZBD), or bicalutamide, dutasteride, and ketoconazole (ZBDK) for 3 months before prostatectomy. Controls included patients receiving combined androgen blockade with luteinizing hormone-releasing hormone agonist and bicalutamide. The primary outcome measure was tissue dihydrotestosterone (DHT) concentration. Results Prostate DHT levels were substantially lower in all experimental arms (0.02 to 0.04 ng/g v 0.92 ng/g in controls; P < .001). The ZBDK group demonstrated the greatest percentage decline in serum testosterone, androsterone, and dehydroepiandrosterone sulfate (P < .05 for all). Staining for AR and the androgen-regulated genes prostate-specific antigen and TMPRSS2 was strongly suppressed in benign glands and moderately in malignant glands (P < .05 for all). Two patients had pathologic complete response, and nine had ≤ 0.2 cm3 of residual tumor (defined as a near-complete response), with the largest numbers of complete and near-complete responses in the ZBDK group. Conclusion Addition of androgen synthesis inhibitors lowers prostate androgens below that achieved with standard therapy, but significant AR signaling remains. Tissue-based analysis of steroids and AR signaling is critical to informing the search for optimal local and systemic control of high-risk prostate cancer. PMID:24323034

  20. Effects of Flutamide on [Methyl-3H]-Choline Uptake in Human Prostate Cancer-3 Cells: A Pilot Study

    PubMed Central

    Al-Saeedi, Fatma

    2007-01-01

    Background: Positron emission tomography using [methyl-11C]-choline is effective in imaging many types of cancer, especially prostate cancer (PC). The antiandrogen flutamide is often used as part of the initial treatment of PC. Data on the effect of flutamide on and methylcholine incorporation into PC-3 cells are lacking in the experimental and literature work. Objectives: The aims of this study were to assess whether human PC-3 cells are susceptible to flutamide and whether the drug modulates the uptake of [methyl-3H]-choline into these cells. Methods: PC-3 cells were treated for 3 days with flutamide (≤100 nmol/L), inhibiting growth by 20% to 70% with control cells included. Two viability tests (cytotoxic analyses), the thiazole blue assay and the trypan blue exclusion method, were used to determine the median inhibitory concentration for flutamide (10 nmol/L). Control and flutamide-treated cells were incubated with [methyl-3H]-choline for 10 minutes and then in nonradioactive medium for 10 minutes to simulate the rapid blood clearance of [methyl-11C]-choline tracer that occurs within 5 to 20 minutes, and then extracted using organic and aqueous solvents to determine the intracellular distribution of the tracer. Protein assay and flow-cytometry analysis were used to determine protein content and DNA synthesis in both control and treated cells. The uptake of [methyl-3H]-choline was normalized to protein content and expressed as mean (SD) dpm/1Jg protein (n = 6). Results: PC-3 cell proliferation was inhibited with flutamide treatment. After treatment of PC-3 cells with flutamide 10 nmol/L for 3 days, cells accumulated DNA during the S phase. Mean (SD) [methyl-3H]-choline uptake was found to be significantly lower with flutamide 10-nmol/L-treated cells compared with control cells (65.95 [0.72] vs 114.21 [0.57] dpm/1Jg protein; P < 0.001); the difference between the 5-nmol/L-treated cells and controls was nonsignificant. Conclusions: In this pilot study, flutamide

  1. [Utilization of self-sampling kits for HPV testing in cervical cancer screening - pilot study].

    PubMed

    Ondryášová, H; Koudeláková, V; Drábek, J; Vaněk, P; Slavkovský, R; Hajdúch, M

    2015-12-01

    To get initial experience with alternative sampling (self-sampling) for HPV testing as the means of cervical cancer screening program. Original work. Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University in Olomouc. Based on expression of interest, 215 self-sampling kits were posted to women. Evalyn(®) Brush Vaginal swabs obtained by self-sampling were analyzed for the presence of HPV infection by Cobas 4800 HPV (Roche) followed by genotyping using PapilloCheck(®) HPV-Screening (Greiner Bio-One). Sixty women randomly chosen from our sample were sent a questionnaire focused on their experience with self-sampling. One hundred seventy-four of 215 (81%) distributed self-sampling devices have been delivered to analysis. All cervicovaginal swabs were sampled correctly and it was possible to analyze them by Cobas 4800 HPV test. Similarly, 98% (171/174) samples were analyzable by PapilloCheck(®) HPV-Screening.One hundred twenty-five (72%) of 174 tested samples were HPV negative. Low risk HPV infection was detected only in 7 samples (4%), and high risk HPV (hrHPV) infection was present in 42 samples (24%). The most frequently detected hrHPV genotypes were HPV16 (11/42; 26%) and HPV53 (6/42; 14%). HrHPV co-infection was detected in 10 cases, in 5 of them lrHPV infection was find also.Of the 60 questionnaires, 48 (80%) were returned. From this group, 47 (98%) women rated their experience with self-sampling device as good to excellent. User manual of self-sampling device was considered good to excellent by all women (100%). All women also rated the convenience of self-sampling device using as good to excellent. As expected, most of the women (n = 42 [88%]) preferred self-sampling to physician sampling. Cervicovaginal self-sampling leads to valid results of HPV screening using two molecular genetics methods and was accepted by Czech women very well. The self-sampling as an opportunity to participate in cervical cancer

  2. A pilot study of carboplatin (JM8, CBDCA) and chlorambucil in combination for advanced ovarian cancer.

    PubMed Central

    Harding, M.; Kennedy, R.; Mill, L.; MacLean, A.; Duncan, I.; Kennedy, J.; Soukop, M.; Kaye, S. B.

    1988-01-01

    Forty-six patients with previously untreated, advanced ovarian cancer received carboplatin (JM8, CBDCA) and chlorambucil (CLB) to assess the efficacy and toxicity of this combination. Carboplatin 300 mg m-2 was given on day 1 with CLB 10 mg daily for 7, 10 or 14 days; 6 treatment courses were given at 4-6 weekly intervals in the absence of disease progression. Tumour response was assessed, where possible, by restaging laparotomy after 6 treatment cycles. Five complete and 16 partial remission were seen in 37 evaluable patients giving an overall response rate of 57%. The median survival of all patients was 15 months. The major toxicity was myelosuppression. Nausea and vomiting were generally minor (WHO, grades I or II) and most courses were given on an outpatient basis. Leucopenia was the major factor causing treatment delays, particularly with the 10 and 14 day CLB regimens. Thrombocytopenia was minimal in the early chemotherapy cycles but the data suggest that cumulative toxicity may occur. This combination may provide a satisfactory degree of efficacy with less toxicity than cisplatin-based regimens. PMID:3064798

  3. New method for detection of gastric cancer by hyperspectral imaging: a pilot study

    NASA Astrophysics Data System (ADS)

    Kiyotoki, Shu; Nishikawa, Jun; Okamoto, Takeshi; Hamabe, Kouichi; Saito, Mari; Goto, Atsushi; Fujita, Yusuke; Hamamoto, Yoshihiko; Takeuchi, Yusuke; Satori, Shin; Sakaida, Isao

    2013-02-01

    We developed a new, easy, and objective method to detect gastric cancer using hyperspectral imaging (HSI) technology combining spectroscopy and imaging A total of 16 gastroduodenal tumors removed by endoscopic resection or surgery from 14 patients at Yamaguchi University Hospital, Japan, were recorded using a hyperspectral camera (HSC) equipped with HSI technology Corrected spectral reflectance was obtained from 10 samples of normal mucosa and 10 samples of tumors for each case The 16 cases were divided into eight training cases (160 training samples) and eight test cases (160 test samples) We established a diagnostic algorithm with training samples and evaluated it with test samples Diagnostic capability of the algorithm for each tumor was validated, and enhancement of tumors by image processing using the HSC was evaluated The diagnostic algorithm used the 726-nm wavelength, with a cutoff point established from training samples The sensitivity, specificity, and accuracy rates of the algorithm's diagnostic capability in the test samples were 78.8% (63/80), 92.5% (74/80), and 85.6% (137/160), respectively Tumors in HSC images of 13 (81.3%) cases were well enhanced by image processing Differences in spectral reflectance between tumors and normal mucosa suggested that tumors can be clearly distinguished from background mucosa with HSI technology.

  4. A Pilot Study on the Potential of RNA-Associated to Urinary Vesicles as a Suitable Non-Invasive Source for Diagnostic Purposes in Bladder Cancer.

    PubMed

    Perez, Amparo; Loizaga, Ana; Arceo, Raquel; Lacasa, Isabel; Rabade, Ainara; Zorroza, Kerman; Mosen-Ansorena, David; Gonzalez, Esperanza; Aransay, Ana M; Falcon-Perez, Juan M; Unda-Urzaiz, Miguel; Royo, Felix

    2014-01-22

    Bladder cancer is one of the most common cancers and, together with prostate carcinoma, accounts for the majority of the malignancies of the genitourinary tract. Since prognosis ameliorates with early detection, it will be beneficial to have a repertoire of diagnostic markers that could complement the current diagnosis protocols. Recently, cell-secreted extracellular vesicles have received great interest as a source of low invasive disease biomarkers because they are found in many body fluids, including urine. The current work describes a pilot study to generate an array-based catalogue of mRNA associated to urinary vesicles, and also a comparison with samples obtained from bladder cancer patients. After an analysis of presence/absence of transcripts in bladder cancer EVs, a list of genes was selected for further validation using PCR technique. We found four genes differentially expressed in cancer samples. LASS2 and GALNT1 were present in cancer patients, while ARHGEF39 and FOXO3 were found only in non-cancer urinary vesicles. Previous studies have pointed to the involvement of those genes in tumour progression and metastasis.

  5. A Pilot Study on the Potential of RNA-Associated to Urinary Vesicles as a Suitable Non-Invasive Source for Diagnostic Purposes in Bladder Cancer

    PubMed Central

    Perez, Amparo; Loizaga, Ana; Arceo, Raquel; Lacasa, Isabel; Rabade, Ainara; Zorroza, Kerman; Mosen-Ansorena, David; Gonzalez, Esperanza; Aransay, Ana M.; Falcon-Perez, Juan M.; Unda-Urzaiz, Miguel; Royo, Felix

    2014-01-01

    Bladder cancer is one of the most common cancers and, together with prostate carcinoma, accounts for the majority of the malignancies of the genitourinary tract. Since prognosis ameliorates with early detection, it will be beneficial to have a repertoire of diagnostic markers that could complement the current diagnosis protocols. Recently, cell-secreted extracellular vesicles have received great interest as a source of low invasive disease biomarkers because they are found in many body fluids, including urine. The current work describes a pilot study to generate an array-based catalogue of mRNA associated to urinary vesicles, and also a comparison with samples obtained from bladder cancer patients. After an analysis of presence/absence of transcripts in bladder cancer EVs, a list of genes was selected for further validation using PCR technique. We found four genes differentially expressed in cancer samples. LASS2 and GALNT1 were present in cancer patients, while ARHGEF39 and FOXO3 were found only in non-cancer urinary vesicles. Previous studies have pointed to the involvement of those genes in tumour progression and metastasis. PMID:24458310

  6. A pilot study of ultrasound-guided electronic brachytherapy for skin cancer

    PubMed Central

    Kim, Yongbok; Tiwari, Hina Arif; Witte, Russell; Stea, Baldassarre

    2015-01-01

    Purpose Electronic brachytherapy (eBT) has gained acceptance over the past 5 years for the treatment of non-melanomatous skin cancer (NMSC). Although the prescription depth and radial margins can be chosen using clinical judgment based on visual and biopsy-derived information, we sought a more objective modality of measurement for eBT planning by using ultrasound (US) to measure superficial (< 5 mm depth) lesions. Material and methods From December 2013 to April 2015, 19 patients with 23 pathologically proven NMSCs underwent a clinical examination and US evaluation of the lesions prior to initiating a course of eBT. Twenty lesions were basal cell carcinoma and 3 lesions were squamous cell carcinoma. The most common location was the nose (10 lesions). A 14 or 18 MHz US unit was used by an experienced radiologist to determine depth and lateral extension of lesions. The US-measured depth was then used to define prescription depth for eBT planning without an added margin. A margin of 7 mm was added radially to the US lateral extent measurements, and an appropriate cone applicator size was chosen to cover the target volume. Results The mean depth of the lesions was 2.1 mm with a range of 1-3.4 mm, and the mean largest diameter of the lesions was 8 mm with a range of 2.6-20 mm. Dose ranged from 32-50 Gy in 8-20 fractions with a median dose of 40 Gy in 10 fractions. All patients had a complete response and no failures have occurred with a median follow-up of 12 months (range of 6-22 months). Also, no prolonged skin toxicities have occurred. Conclusions A routinely available radiological US unit can objectively determine depth and lateral extension of NMSC lesions for more accurate eBT treatment planning, and should be considered in future eBT treatment guidelines. PMID:26622244

  7. Online Adaptive Radiotherapy for Muscle-Invasive Bladder Cancer: Results of a Pilot Study

    SciTech Connect

    Foroudi, Farshad; Wong, Jacky; Kron, Tomas; Rolfo, Aldo; Haworth, Annette; Roxby, Paul; Thomas, Jessica; Herschtal, A.; Pham, Daniel; Williams, Scott; Tai, Keen Hun; Duchesne, Gillian

    2011-11-01

    Purpose: To determine the advantages and disadvantages of daily online adaptive image-guided radiotherapy (RT) compared with conventional RT for muscle-invasive bladder cancer. Methods and Materials: Twenty-seven patients with T2-T4 transitional cell carcinoma of the bladder were treated with daily online adaptive image-guided RT using cone-beam computed tomography (CBCT). From day 1 daily soft tissue-based isocenter positioning was performed using CBCT images acquired before treatment. Using a composite of the initial planning CT and the first five daily CBCT scans, small, medium, and large adaptive plans were created. Each of these adaptive plans used a 0.5-cm clinical target volume (CTV) to planning target volume expansion. For Fractions 8-32, treatment involved daily soft tissue-based isocenter positioning and selection of suitable adaptive plan of the day. Treating radiation therapists completed a credentialing program, and one radiation oncologist performed all the contouring. Comparisons were made between adaptive and conventional treatment on the basis of CTV coverage and normal tissue sparing. Results: All 27 patients completed treatment per protocol. Bladder volume decreased with time or fraction number (p < 0.0001). For the adaptive component (Fractions 8-32) the small, medium, large, and conventional plans were used in 9.8%, 49.2%, 39.5%, and 1.5% of fractions, respectively. For the adaptive strategy, 2.7% of occasions resulted in a CTV V95 <99%, compared with 4.8% of occasions for the conventional approach (p = 0.42). Mean volume of normal tissue receiving a dose >45 Gy was 29% (95% confidence interval, 24-35%) less with adaptive RT compared with conventional RT. The mean volume of normal tissue receiving >5 Gy was 15% (95% confidence interval, 11-18%) less with adaptive RT compared with conventional RT. Conclusions: Online adaptive radiotherapy is feasible in an academic radiotherapy center. The volume of normal tissue irradiated can be significantly

  8. Perception of cancer and inconsistency in medical information are associated with decisional conflict: a pilot study of men with prostate cancer who undergo active surveillance.

    PubMed

    Goh, Alvin C; Kowalkowski, Marc A; Bailey, Donald E; Kazer, Meredith W; Knight, Sara J; Latini, David M

    2012-07-01

    Men with prostate cancer who choose active surveillance may experience anxiety and depression. Higher anxiety related to uncertainty surrounding cancer has been shown to increase the likelihood of choosing active treatment in the absence of a clinical indication. Certain characteristics, including physician influence and a neurotic personality, may also increase the risk of psychological distress. Our study identified particular areas that may affect the degree of satisfaction or uncertainty experienced by men choosing active surveillance. We showed that men with a positive outlook who perceived that they were receiving consistent medical information had improved ability to manage uncertainty and felt more in control of their decision-making. Men who were confident in their ability to manage prostate-related symptoms also had less insecurity with their decision. To understand the factors associated with decision-making, we conducted a telephone-based survey as part of a pilot study to develop a psychoeducational intervention for men with prostate cancer who undergo active surveillance. From 2007 to 2008, we conducted a cross-sectional study of 34 individuals on active surveillance for prostate cancer. We examined how specific mental health, quality of life and sociodemographic characteristics relate to decision-making. Five validated decision-making scales were used as primary outcomes reflecting the amount of satisfaction, regret and conflict a participant experienced about his decision to undergo active surveillance. A multivariate regression model was developed to identify specific psychosocial factors related to the decision-making outcomes. Primary analyses focused on the decisional satisfaction and conflict measures, as the decisional regret measure showed poor reliability (α < 0.70) in this sample. Four psychosocial measures showed strong associations across the decision-making subscales, including the Fife Constructed Meaning Scale (Pearson r > 0

  9. Symptom assessment of patients with advanced cancer and AIDS and their family caregivers: the results of a quality-of-life pilot study.

    PubMed

    Sherman, Deborah Witt; Ye, Xiang Y; Beyer McSherry, Christina; Parkas, Valerie; Calabrese, Miriam; Gatto, Maria

    2007-01-01

    This longitudinal pilot study examined differences in demographic characteristics of 101 patients with advanced illness (cancer, AIDS) and 81 Family caregivers, evaluated the reliability of the Memorial Symptom Assessment Scale for these patients and their family caregivers; obtained preliminary data regarding similarities or differences in the symptom experience oF these patients and their family caregivers and changes in symptoms over time; and identified demographic variables that may be potential covariates related to the symptom experience. All demographic variables were significantly different for patients with advanced cancer and AIDS, and their symptom experience is similar only with regard to psychologic symptoms; however, based on the Memorial Symptom Assessment Scale, cancer and AIDS patients and their family caregivers have similar symptom experiences, indicating the need for palliative care for both patients and family. Further research is needed to establish the reliability of the Memorial Symptom Assessment Scale for use with family caregivers.

  10. Pilot Study of Therapy Dog Visits for Inpatient Youth With Cancer.

    PubMed

    Chubak, Jessica; Hawkes, Rene; Dudzik, Christi; Foose-Foster, Jessica M; Eaton, Lauren; Johnson, Rebecca H; Macpherson, Catherine Fiona

    This study assessed the feasibility of studying animal-assisted activities (AAA) in inpatient pediatric oncology and collected preliminary data on potential benefits of AAA for this population. Patients at a large pediatric hospital were identified using electronic medical records and approached with physician approval. Patients completed surveys before and after a therapy dog visit in their private hospital room. Data on infections were ascertained by electronic medical record review. Provider surveys were placed in provider common areas and distributed through a link in an e-mail. We summarized resultsusing descriptive statistics and estimated mean changes in pre- and postintervention distress and conducted hypothesis tests using the paired t test. The study population (mean age = 12.9 years) consisted of 9 females and 10 males. Following the therapy dog visit, patients had lower distress and significant decreases in worry, tiredness, fear, sadness, and pain. Providers were generally supportive of the intervention. Eight patients developed infections during the 14 days after the dog visit but none could be clearly attributed to the therapy dog visit. The study's primary limitation was that there was no control group. However, results support the feasibility of and need for future studies on AAA in pediatric oncology.

  11. Enhancement of myeloperoxidase activity in WBCS in oral cancer patients treated with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)-A pilot study.

    PubMed

    Ananth, N; Balaji, G B; Vasudevan, D M; D'Souza, V; Rao, A V; Nambiar, D

    1998-07-01

    In a pilot study with five oral cancer patients undergoing radiotherapy (RT) three were given Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as a protective agent to reduce the mucosal inflammation during radiotherapy. The myeloperoxidase (MPO) enzyme activity in WBC was quantitated. The three patients showed a significant increase in the MPO activity when compared with two untreated controls indicating the efficacy of GM-CSF as a protective agent. It is suggested that further detailed studies with larger number of patients would be useful.

  12. Relation Between Periodontal Status and Pre-Cancerous Condition (Oral Lichen Planus): A Pilot Study.

    PubMed

    Rai, Narendra Parkash; Kumar, Prafful; Mustafa, Shabil M; Divakar, Darshan D; Kheraif, Abdulaziz Al; Ramakrishnaiah, Ravikumar; Vellapally, Sajith; Dalati, M H N; Parine, Narashimha Reddy; Anil, Sukumaran

    2016-01-01

    Oral lichen planus (OLP) is a common chronic mucocutaneous disease mostly seen in middle aged and elderly females. Oral lichen planus can occur in different oral sites such as gingiva, labial, buccal mucosa and on the tongue. And can have an indirect effect on initiating periodontitis. The purpose of the study was to evaluate the periodontal status of OLP patients and compare it with that of healthy controls. The presence of erosive lesions among gingival tissues makes oral hygiene procedures difficult to perform for obvious reasons. Plaque control and rigorous oral hygiene are primary requisites for the treatment of any oro-mucosal disease. Thirty patients with the erosive and reticular form of OLP as a study group and 30 healthy subjects as a control group were selected. The periodontal status of all subjects including gingival index (GI), Russell's periodontal index (PI) and bleeding on probing (BOP) were evaluated in both groups. Finally, the data was analyzed by a paired t-test using SPSS software v. 22. The mean values of GI, PI and BOP were observed to be higher in the study group compared to the control group, and this was statistically significant (p < 0.05). The results shown are suggestive that periodontal status was poor in the study group as compared to the control group. Further studies need to investigate periodontal status in oral lichen planus patients with larger sample size, and careful follow-up of these will assure an increase in the quality of life of these patients. The patient should be informed regarding the risk of periodontal problems in OLP and should be advised to have regular dental checkups to avoid a worsening of the conditio.

  13. Postoperative assessment of surgical clip position in 16 dogs with cancer: a pilot study.

    PubMed

    McEntee, Margaret C; Samii, Valerie F; Walsh, Peter; Hornof, William J

    2004-01-01

    Metallic hemoclips or surgical staples were inserted in 16 tumor-bearing dogs at the time of surgical resection of the tumor. Orthogonal radiographs were taken immediately postoperatively and after wound healing to visualize the location and number of hemoclips or metallic staples. A shift in hemoclip/staple position was identified in nine dogs, mainly from positioning during radiography. In three dogs, an absolute shift in marker position was identified. Based on this study, it appears that the placement of surgical clips is potentially useful in identifying the tumor bed, which may be of benefit in establishing radiation treatment fields.

  14. A Pilot Feasibility Study of TNFerade™ Biologic with Capecitabine and Radiation Therapy Followed by Surgical Resection for the Treatment of Rectal Cancer

    PubMed Central

    Citrin, Deborah; Camphausen, Kevin; Wood, Bradford J.; Quezado, Martha; Denobile, John; Pingpank, James F.; Royal, Richard E.; Alexander, H. Richard; Seidel, Geoffrey; Steinberg, Seth M.; Shuttack, Yvonne; Libutti, Steven K.

    2011-01-01

    Objective: The purpose of this pilot study was to evaluate the feasibility and tolerability of weekly intratumoral TNFerade™ injections combined with concurrent capecitabine and radiotherapy in the treatment of patients with locally advanced rectal cancer. Methods Patients with T3, T4, or N+ rectal cancer received radiotherapy to a total dose of 50.4–54 Gy in combination with capecitabine 937.5 mg/m2 p.o. b.i.d. TNFerade™ at a dose of 4 × 1010 particle units was injected into the rectal tumor on the first day of radiotherapy and weekly for a total of 5 injections. Surgery was performed 5–10 weeks after the completion of chemoradiation. Results Nine patients were enrolled in this pilot trial. The stage was cT2 in 2 patients, cT3 in 6 patients, cT4 in 1 patient, N– in 7 patients and N+ in 2 patients. Eight patients completed all treatments. Grade 3 hematologic toxicity was observed in 2 patients. There was no toxicity directly attributable to the injection procedure. A complete pathologic response was observed in 2 of 9 patients. Conclusions This study demonstrates the feasibility of weekly intratumoral TNFerade™ injections during chemoradiotherapy for locally advanced rectal cancer. Pathologic responses with this combination compare favorably to published rates. PMID:21447969

  15. [Linkage of secondary data with cancer registry data on the basis of encrypted personal identifiers - results from a pilot study in North Rhine-Westphalia].

    PubMed

    Kajüter, H; Batzler, W U; Krieg, V; Heidinger, O; Hense, H-W

    2012-08-01

    The Cancer Registry of North-Rhine-Westphalia stores exclusively encrypted personal identifiers of registered cancer patients. Therefore, comparisons with secondary data sets can only be performed by record linkage procedures that are based on encrypted personal identifiers. We report on a pilot study which linked encrypted personal data from the disease management program for patients with diabetes mellitus type 2 (DMP-DM2) with the database of the EKR NRW in order to test the feasibility and efficiency of these record linkage procedures. Personal identifying variables of the DMP records were encrypted in a 2-stage process before being sent electronically to the EKR NRW where they were subsequently submitted to a probabilistic record linkage with the registry data. The study included 27 450 participants who were insured at the AOK NordWest, residents of the district Münster and who were aged 40-79 years at the time of first enrolment to the DMP-DM2 between June 2003-July 2008. The electronic processing time of the semi-automatic record linkage procedure took about 24 h. Approximately 2% of the records had to be reviewed manually. After exclusion of prevalent cancer cases, multiple primaries and inadequate data, 26 742 participants (47.3% men; 52.7% women) remained in the data set. About 1 364 cohort members (759 men, 605 women) were diagnosed with cancer after submission to the disease management program. The DMP-DM2 records were encrypted and linked to cancer registry data with a moderate personnel and financial input and high efficiency. Linked records were instantly usable for epidemiological analyses. Experiences of the pilot study suggest that future linkage studies can further advance the level of data protection, without losses in efficiency, by moderately complex software modifications and amendments of the data flow. © Georg Thieme Verlag KG Stuttgart · New York.

  16. Palpation device for the identification of kidney and bladder cancer: a pilot study.

    PubMed

    Lee, Jae Won; Lorenzo, Enrique Ian S; Ahn, Bummo; Oh, Cheol Kyu; Kim, Hyung-Joo; Han, Woong Kyu; Kim, Jung; Rha, Koon Ho

    2011-09-01

    To determine the ability of a novel palpation device to differentiate between benign and malignant tissues of the kidney and bladder by measuring tissue elasticity. A novel palpation device was developed, mainly composed of a micromotor, a linear position sensor, a force transducer, and a hemisphere tip and cylindrical body probe. Motion calibration as well as performance validation was done. The tissue elasticity of both benign and malignant tissues of the kidney and bladder was measured using this device. A single investigator performed the ex-vivo palpation experiment in twelve kidneys and four bladder specimens. Malignant tissues were made available from partial nephrectomy specimens and radical cystectomy specimens. Palpations for benign renal parenchyma tissue were carried out on nephroureterectomy specimens while non-involved areas in the radical cystectomy specimens were used for benign bladder samples. Elastic modulus (Young's modulus) of tissues was estimated using the Hertz-Sneddon equation from the experimental results. These were then compared using a t-test for independent samples. Renal cell carcinoma tissues appear to be softer than normal kidney tissues, whereas tissues from urothelial carcinoma of the bladder appear to be harder than normal bladder tissues. The results from renal cell carcinoma differed significantly from those of normal kidney tissues (p=0.002), as did urothelial carcinoma of the bladder from normal bladder tissues (p=0.003). Our novel palpation device can potentially differentiate between malignant and benign kidney and bladder tissues. Further studies are necessary to verify our results and define its true clinical utility.

  17. Palpation Device for the Identification of Kidney and Bladder Cancer: A Pilot Study

    PubMed Central

    Lee, Jae Won; Lorenzo, Enrique Ian S.; Ahn, Bummo; Oh, Cheol Kyu; Kim, Hyung-Joo; Han, Woong Kyu; Kim, Jung

    2011-01-01

    Purpose To determine the ability of a novel palpation device to differentiate between benign and malignant tissues of the kidney and bladder by measuring tissue elasticity. Materials and Methods A novel palpation device was developed, mainly composed of a micromotor, a linear position sensor, a force transducer, and a hemisphere tip and cylindrical body probe. Motion calibration as well as performance validation was done. The tissue elasticity of both benign and malignant tissues of the kidney and bladder was measured using this device. A single investigator performed the ex-vivo palpation experiment in twelve kidneys and four bladder specimens. Malignant tissues were made available from partial nephrectomy specimens and radical cystectomy specimens. Palpations for benign renal parenchyma tissue were carried out on nephroureterectomy specimens while non-involved areas in the radical cystectomy specimens were used for benign bladder samples. Elastic modulus (Young's modulus) of tissues was estimated using the Hertz-Sneddon equation from the experimental results. These were then compared using a t-test for independent samples. Results Renal cell carcinoma tissues appear to be softer than normal kidney tissues, whereas tissues from urothelial carcinoma of the bladder appear to be harder than normal bladder tissues. The results from renal cell carcinoma differed significantly from those of normal kidney tissues (p=0.002), as did urothelial carcinoma of the bladder from normal bladder tissues (p=0.003). Conclusion Our novel palpation device can potentially differentiate between malignant and benign kidney and bladder tissues. Further studies are necessary to verify our results and define its true clinical utility. PMID:21786441

  18. A pilot study to investigate the role of the 26S proteasome in radiotherapy resistance and loco-regional recurrence following breast conserving therapy for early breast cancer.

    PubMed

    Elfadl, Dalia; Hodgkinson, Victoria C; Long, Ervine D; Scaife, Lucy; Drew, Philip J; Lind, Michael J; Cawkwell, Lynn

    2011-08-01

    Breast conserving therapy is a currently accepted method for managing patients with early stage breast cancer. However, approximately 7% of patients may develop loco-regional tumour recurrence within 5 years. We previously reported that expression of the 26S proteasome may be associated with radio-resistance. Here we aimed to analyse the 26S proteasome in a pilot series of early breast cancers and correlate the findings with loco-regional recurrence. Fourteen patients with early breast cancer who developed loco-regional recurrence within 4 years of completing breast conserving therapy were selected according to strict criteria and compared with those from 14 patients who were disease-free at 10 years. Decreased expression of the 26S proteasome was significantly associated with radio-resistance, manifested as the development of a loco-regional recurrence within 4 years of breast conserving therapy (p = 0.018). This small pilot study provides further suggestion that the 26S proteasome may be associated with response to radiotherapy.

  19. ‘Act on Oncology’ as a New Comprehensive Approach to Assess Prostate Cancer Centres – Method Description and Results of a Pilot Study

    PubMed Central

    Voigt, Wieland; Hoellthaler, Josef; Magnani, Tiziana; Corrao, Vito; Valdagni, Riccardo

    2014-01-01

    Background Multidisciplinary care of prostate cancer is increasingly offered in specialised cancer centres. It requires the optimisation of medical and operational processes and the integration of the different medical and non-medical stakeholders. Objective To develop a standardised operational process assessment tool basing on the capability maturity model integration (CMMI) able to implement multidisciplinary care and improve process quality and efficiency. Design, Setting, and Participants Information for model development was derived from medical experts, clinical guidelines, best practice elements of renowned cancer centres, and scientific literature. Data were organised in a hierarchically structured model, consisting of 5 categories, 30 key process areas, 172 requirements, and more than 1500 criteria. Compliance with requirements was assessed through structured on-site surveys covering all relevant clinical and management processes. Comparison with best practice standards allowed to recommend improvements. ‘Act On Oncology’(AoO) was applied in a pilot study on a prostate cancer unit in Europe. Results and Limitations Several best practice elements such as multidisciplinary clinics or advanced organisational measures for patient scheduling were observed. Substantial opportunities were found in other areas such as centre management and infrastructure. As first improvements the evaluated centre administration described and formalised the organisation of the prostate cancer unit with defined personnel assignments and clinical activities and a formal agreement is being worked on to have structured access to First-Aid Posts. Conclusions In the pilot study, the AoO approach was feasible to identify opportunities for process improvements. Measures were derived that might increase the operational process quality and efficiency. PMID:25192213

  20. Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

    PubMed Central

    Tröger, Wilfried; Jezdić, Svetlana; Ždrale, Zdravko; Tišma, Nevena; Hamre, Harald J.; Matijašević, Miodrag

    2009-01-01

    Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia. Patients and Methods: We conducted a prospective randomized open label pilot study with 95 patients randomized into three groups. Two groups received Iscador® M special (IMS) or a different mistletoe preparation, respectively, additionally to chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluoro-uracil (CAF). A control group received CAF with no additional therapy. Here we report the comparison IMS (n = 30) vs. control (n = 31). Quality of life including fatigue was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). Neutropenia was defined as neutrophil counts <1,000/μl and assessed at baseline and one day before each CAF cycle. Results: In the descriptive analysis all 15 scores of the EORTC-QLQ-C30 showed better quality of life in the IMS group compared to the control group. In 12 scores the differences were significant (p < 0.02) and nine scores showed a clinically relevant and significant difference of at least 5 points. Neutropenia occurred in 3/30 IMS patients and in 8/31 control patients (p = 0.182). Conclusions: This pilot study showed an improvement of quality of life by treating breast cancer patients with IMS additionally to CAF. CAF-induced neutropenia showed a trend to lower frequency in the IMS group. PMID:21556248

  1. The risk of prostate cancer in pilots: a meta-analysis.

    PubMed

    Raslau, David; Summerfield, Douglas T; Abu Dabrh, Abd M; Steinkraus, Lawrence W; Murad, Mohammad H

    2015-02-01

    Aviation exposes pilots to various occupationally related hazards, including ionizing radiation and chemical combustion. The possible increased risk of prostate cancer among pilots in comparison to the general population is a subject of debate. This systematic review and meta-analysis aimed to determine the quality of supporting evidence and magnitude of this association. All studies pertaining to prostate cancer in pilots were retrieved from multiple databases and from a manual search. Any study that assessed the incidence of prostate cancer relative to the incidence in the general population was included regardless of language or size. A random effect model was used to pool relative risks (RR) across studies. Heterogeneity was assessed using the Q statistic and I². Eight studies with a low risk of bias were included in the meta-analysis. Pilots had an increased risk of developing prostate cancer compared to the general population [RR 2.0; 95% confidence interval (CI), 1.5-2.7]. The analysis was associated with substantial heterogeneity (I² = 79%). Several subgroups had significantly increased risk, such as African American pilots (RR 10.00; 95% CI, 5.04-19.86) and military pilots (RR 3.30; 95% CI, 2.03-5.39). Pilots are at least twice as likely to develop prostate cancer compared to the general population. The implications of these findings are important considering the high prevalence of prostate cancer and the large number of pilots in the workforce.

  2. The Meaning-Making intervention (MMi) appears to increase meaning in life in advanced ovarian cancer: a randomized controlled pilot study.

    PubMed

    Henry, Melissa; Cohen, S Robin; Lee, Virginia; Sauthier, Philippe; Provencher, Diane; Drouin, Pierre; Gauthier, Philippe; Gotlieb, Walter; Lau, Susie; Drummond, Nancy; Gilbert, Lucy; Stanimir, Gerald; Sturgeon, Jeremy; Chasen, Martin; Mitchell, Julie; Huang, Lina Nuoxin; Ferland, Mira-Klode; Mayo, Nancy

    2010-12-01

    This pilot study aimed to provide supportive evidence for the acceptability and usefulness of the Meaning-Making intervention (MMi) in patients newly diagnosed with Stage III or IV ovarian cancer, and to provide estimates of parameters needed to design a full-scale study. A randomized controlled trial with 24 patients (12 experimental and 12 control) was conducted. Existential well-being (primary outcome), overall quality of life, distress, anxiety, depression and self-efficacy were measured. Compared to the control group, patients in the experimental group had a better sense of meaning in life at one and three months post-intervention. The MMi seems a promising intervention for advanced cancer patients, and a full randomized controlled trial is warranted to further investigate its efficacy.

  3. Periprostatic adipose tissue from obese prostate cancer patients promotes tumor and endothelial cell proliferation: a functional and MR imaging pilot study.

    PubMed

    Venkatasubramanian, Palamadai N; Brendler, Charles B; Plunkett, Beth A; Crawford, Susan E; Fitchev, Philip S; Morgan, Gina; Cornwell, Mona L; McGuire, Michael S; Wyrwicz, Alice M; Doll, Jennifer A

    2014-02-01

    Obesity, particularly visceral adiposity, confers a worse prognosis for prostate cancer (PCa) patients, and increasing periprostatic adipose (PPA) tissue thickness or density is positively associated with more aggressive disease. However, the cellular mechanism of this activity remains unclear. Therefore, in this pilot study, we assessed the functional activity of PPA tissue secretions and established a biochemical profile of PPA as compared to subcutaneous adipose (SQA) tissues from lean, overweight and obese PCa patients. Adipose tissues were collected from PCa patients undergoing surgical prostate removal. Tissues were analyzed by histologic and magnetic resonance (MR) techniques. Explant tissue culture secretions were used in proliferation assays on PCa and endothelial cells. PPA secretions obtained from obese patients were significantly more pro-proliferative in both PCa and endothelial cells as compared to PPA obtained from lean or overweight men and SQA tissues. Consistent with this, PPA microvessel density was increased, and the T2 relaxation time was decreased, compared to SQA tissues, and we observed a modest, inverse correlation between the T2 and tumor stage. Moreover, the ratio of unsaturated to saturated fatty acids, obtained using MR spectroscopy, showed a modest, inverse correlation with Gleason score. These pilot data show that PPA stimulates PCa cell proliferation and angiogenesis and that obesity intensifies this activity, thus generating a mechanistic hypothesis to explain the worse prognosis observed in obese PCa patients. Our pilot study also shows that MR technology may be useful in further elucidating the relationship between obesity and PCa progression.

  4. Occult cancer in patients with deep-vein thrombosis in a general hospital at Mexico City: A pilot study.

    PubMed

    Ramírez-Serrano Torres, Christian O; Román-Guzmán, Edgardo; Ortiz-Mendoza, Carlos-Manuel

    2017-01-01

    We aimed to explore the frequency of occult cancer in patients with deep-vein thrombosis (DVT) at a general hospital in Mexico City. From March 2012 to February 2015, all patients with primary DVT of lower extremities attended in the emergency department of our hospital were studied. Initially, all patients were evaluated with clinical history, physical examination, basic laboratories, abdominal ultrasound, chest X-ray, and duplex venous ultrasonography. In a case-by-case approach, if necessary, computed tomography, endoscopy, colonoscopy, and tumor markers were done. From 182 patients with primary DVT, 30 (16.5%) presented occult cancer: Thirteen males and 17 females, with an average age of 61 years. In males, prostate cancer prevailed (6/13, 46%); meanwhile, in females, pelvic gynecologic cancers predominated (7/17, 41%). Our results suggest that in Mexican patients with primary DVT, occult cancer is frequent.

  5. Occult cancer in patients with deep-vein thrombosis in a general hospital at Mexico City: A pilot study

    PubMed Central

    Ramírez-Serrano Torres, Christian O; Román-Guzmán, Edgardo; Ortiz-Mendoza, Carlos-Manuel

    2017-01-01

    Background: We aimed to explore the frequency of occult cancer in patients with deep-vein thrombosis (DVT) at a general hospital in Mexico City. Materials and Methods: From March 2012 to February 2015, all patients with primary DVT of lower extremities attended in the emergency department of our hospital were studied. Initially, all patients were evaluated with clinical history, physical examination, basic laboratories, abdominal ultrasound, chest X-ray, and duplex venous ultrasonography. In a case-by-case approach, if necessary, computed tomography, endoscopy, colonoscopy, and tumor markers were done. Results: From 182 patients with primary DVT, 30 (16.5%) presented occult cancer: Thirteen males and 17 females, with an average age of 61 years. In males, prostate cancer prevailed (6/13, 46%); meanwhile, in females, pelvic gynecologic cancers predominated (7/17, 41%). Conclusion: Our results suggest that in Mexican patients with primary DVT, occult cancer is frequent. PMID:28616050

  6. Improving communication with palliative care cancer patients at home - A pilot study of SAGE & THYME communication skills model.

    PubMed

    Griffiths, Jane; Wilson, Charlotte; Ewing, Gail; Connolly, Michael; Grande, Gunn

    2015-10-01

    To pilot an evidence-based communication skills model (SAGE & THYME) with UK District Nurses (DNs) who visit patients with advanced cancer early in the dying trajectory. Evidence suggests that DNs lack confidence in communication skills and in assessing cancer patients' psycho-social needs; also that they lack time. SAGE & THYME is a highly structured model for teaching patient centred interactions. It addresses concerns about confidence and time. Mixed methods. 33 DNs were trained in SAGE & THYME in a three hour workshop and interviewed in focus groups on three occasions: pre-training, immediately post-training and two months post-training. Questionnaires measuring perceived outcomes of communication, confidence in communication and motivation to use SAGE & THYME were administered at the focus groups. SAGE & THYME provided a structure for conversations and facilitated opening and closing of interactions. The main principle of patient centeredness was reportedly used by all. Knowledge about communication behaviours helpful to patients improved and was sustained two months after training. Increased confidence in communication skills was also sustained. Motivation to use SAGE & THYME was high and remained so at two months, and some said the model saved them time. Challenges with using the model included controlling the home environment and a change in style of communication which was so marked some DNs preferred to use it with new patients. Training DNs in SAGE & THYME in a three hour workshop appears to be a promising model for improving communication skills when working with cancer patients. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

  7. Use of (99m)Tc-Tilmanocept as a Single Agent for Sentinel Lymph Node Identification in Breast Cancer: A Retrospective Pilot Study.

    PubMed

    Unkart, Jonathan T; Wallace, Anne M

    2017-09-01

    (99m)Tc-tilmanocept received recent Food and Drug Administration approval for lymphatic mapping in 2013. However, to our knowledge, no prior studies have evaluated the use of (99m)Tc-tilmanocept as a single agent in sentinel lymph node (SLN) biopsy in breast cancer. Methods: We executed this retrospective pilot study to assess the ability of (99m)Tc-tilmanocept to identify sentinel nodes as a single agent in clinically node-negative breast cancer patients. Patients received a single intradermal injection overlying the tumor of either 18.5 MBq (0.5 mCi) of (99m)Tc-tilmanocept on the day of surgery or 74.0 MBq (2.0 mCi) on the day before surgery by a radiologist. Immediate 3-view lymphoscintigraphy was performed. Intraoperatively, SLNs were identified with a portable γ-probe. A node was classified as hot if the count (per second) of the node was more than 3 times the background count. Descriptive statistics are reported. Results: Nineteen patients underwent SLN biopsy with single-agent (99m)Tc-tilmanocept. Immediate lymphoscintigraphy identified at least 1 sentinel node in 13 of 17 patients (76.5%). Intraoperatively, at least 1 (mean, 1.7 ± 0.8; range, 1-3) hot node was identified in all patients. Three patients (15.8%) had 1 disease-positive SLN. Conclusion: In this small, retrospective pilot study, (99m)Tc-tilmanocept performed well as a single agent for intraoperative sentinel node identification in breast cancer. A larger, randomized clinical trial is warranted to compare (99m)Tc-tilmanocept as a single agent with other radiopharmaceuticals for sentinel node identification in breast cancer. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

  8. Predictors of skin cancer in commercial airline pilots

    PubMed Central

    Swearingen, Christopher J.; Kilmer, Jeffrey B.

    2009-01-01

    Background Skin cancers among commercial airline pilots have been reported to occur at increased rates in pilot populations worldwide. The reasons for these increases are unclear, but postulated factors include ionizing radiation, circadian disruption and leisure sun exposure. Aims To investigate the potential association of these occupational and lifestyle factors, as well as medical history and skin type, with non-melanoma skin cancer in pilots. Methods Data were collected using a confidential Internet survey administered in collaboration with the Air Line Pilots Association International to all active pilots in four US commercial airlines. Pilots with non-melanoma skin cancer were compared to those without using multivariable analysis. Results The response rate was 19%. Among pilots flying <20 years prior to diagnosis, factors associated with increased odds of non-melanoma skin cancer were at-risk skin type, childhood sunburns and family history of non-melanoma skin cancer. Off-duty sunscreen use and family history of melanoma were protective. Among pilots with ≥20 years flight time prior to diagnosis, childhood sunburns and family history of non-melanoma skin cancer persisted as risk factors, with the addition of flight time at high latitude. Conclusions Further investigation regarding the potential health impact of long-term flying at high latitudes is recommended. Additionally, occupational health programmes for pilots should stress awareness of and protection against established risk factors for non-melanoma skin cancer. PMID:19465434

  9. Impact of a multimedia e-learning module on colon cancer literacy: a community-based pilot study.

    PubMed

    Holubar, Stefan D; Hassinger, J Peyton; Dozois, Eric J; Wolff, Bruce G; Kehoe, Michael; Cima, Robert R

    2009-10-01

    We aimed to determine if an e-learning module could improve colon cancer literacy in a community-based cohort, while obtaining variability estimates for subsequent study. A convenience sample of subjects attending a health-education fair was surveyed to determine colon cancer literacy before-and-after viewing a colon cancer e-learning module. The difference in cancer literacy scores was assessed for significance using univariate analysis. Twenty-two eligible subjects completed the survey: mean age 77.2+/-7.5 y, 55% women; 67% had at least some graduate-level education. Baseline colon cancer literacy was 72.6% +/- 11.6%; after the e-learning module, the mean colon cancer literacy score was 75.5% +/- 12.2%, representing a 3% improvement (P=0.33). After excluding a single problematic item identified by item analysis, the adjusted improvement was 7% (P=0.04). Invasiveness, malignant, and metastatic remained poorly understood concepts, while a large improvement (45%) was seen regarding the role of routine lymphadenectomy. Subject satisfaction with the module was universally (100%) high or very high. Use of an e-learning module is associated with high patient satisfaction, and has potential to improve colon cancer literacy in laypersons. Randomized study is warranted to determine the incremental impact of this and other multimedia educational interventions.

  10. Changes in microflora in dental plaque from cancer patients undergoing chemotherapy and the relationship of these changes with mucositis: A pilot study

    PubMed Central

    Caldarazzo, Vito; Ottolenghi, Livia

    2015-01-01

    Background To assess changes in oral micro flora in dental plaque from cancer patients within 7 days of the first course of chemotherapy, and the relationship of the changes with mucositis. Material and Methods Thirty cancer patients, divided into a test group undergoing chemotherapy and a control group no undergoing chemotherapy, were enrolled in this pilot study. Oral micro flora were cultured from three samples of dental plaque at t0 (before chemotherapy), t1 (1 day after chemotherapy) and t2 (7 days after chemotherapy). Single and crossed descriptive analyses were used to establish prevalence, and the χ2 test was used to establish the statistical significance of the differences observed in distributions (significance level: P<0.05. Results In most patients (57%), oral micro flora consisted mainly of Gram-positive cocci, while the remaining 43% of the bacterial flora also had periodontal-pathogenic species. No Porphyromonas gingivalis appeared in the test group. Actinobacillus was the least frequently found bacterium among periodontal pathogens in the test group, while Fusobacterium nucleatum was the most frequently found. No significant differences were found in quantitative bacterial changes between t0, t1 and t2 in either the test or control groups, or between the two groups. According to World Health Organization scores, oral mucositis developed in 10 patients (66.6%) in the test group. Conclusions The results of this pilot study indicate that there were no changes in microflora in dental plaque in cancer patients within 7 days of the first course of chemotherapy. No correlations between oral mucositis and specific microorganisms were assessed. Key words: Oral microflora, dental plaque, cancer patients, chemotherapy. PMID:25662538

  11. Community-based participatory research to improve life quality and clinical outcomes of patients with breast cancer (DianaWeb in Umbria pilot study)

    PubMed Central

    Villarini, Milena; Lanari, Chiara; Nucci, Daniele; Gianfredi, Vincenza; Marzulli, Tiziana; Berrino, Franco; Borgo, Alessandra; Bruno, Eleonora; Gargano, Giuliana; Moretti, Massimo; Villarini, Anna

    2016-01-01

    Introduction Breast cancer (BC) is the most frequent cancer in Europe and the International Agency for Research on Cancer (IARC) has estimated over 460 000 incident cases per year. Survival among patients with BC has increased in the past decades and EUROCARE-5 has estimated a 5-year relative survival rate of 82% for patients diagnosed in 2000–2007. There is growing evidence that lifestyle (such as a diet based on Mediterranean principles associated with moderate physical activity) may influence prognosis of BC; however, this information is not currently available to patients and is not considered in oncology protocols. Only a few epidemiological studies have investigated the role of diet in BC recurrence and metastasis. Methods and analysis DianaWeb is a community-based participatory research dedicated to patients with BC and represents a collaborative effort between participants and research institutions to determine if specified changes in lifestyle would result in improved outcomes in terms of quality of life or survival. The aim of the study is to recruit a large number of participants, to monitor their lifestyle and health status over time, to provide them tips to encourage sustainable lifestyle changes, to analyse clinical outcomes as a function of baseline risk factors and subsequent changes, and to share with patients methodologies and results. DianaWeb uses a specific interactive website (http://www.dianaweb.org/) and, with very few exceptions, all communications will be made through the web. In this paper we describe the pilot study, namely DianaWeb in Umbria. Ethics and dissemination DianaWeb does not interfere with prescribed oncological treatments; rather, it recommends that participants should follow the received prescriptions. The results will be used to plan guidelines for nutrition and physical activity for patients with BC. The pilot study was approved by the ethics committee of the University of Perugia (reference number 2015-002), and is

  12. A Randomized Controlled Pilot Study Assessing Feasibility and Impact of Yoga Practice on Quality of Life, Mood, and Perceived Stress in Women With Newly Diagnosed Breast Cancer

    PubMed Central

    Stan, Daniela L; Jenkins, Sarah M; Huebner, Marianne; Borg, Beth A; Thomley, Barbara S; Cutshall, Susanne M; Singh, Ravinder; Kohli, Sadhna; Boughey, Judy C; Lemaine, Valerie; Solberg Nes, Lise

    2012-01-01

    Background: A breast cancer diagnosis can entail numerous physical and psychosocial challenges. Yoga practice (YP) may contribute to improved well-being for these patients. Primary Study Objective: Investigate feasibility and impact of YP on quality of life (QoL), mood, fatigue, and perceived stress immediately after breast cancer diagnosis. Methods: Thirty women were randomly assigned to a yoga group (YG) or control group (CG) immediately after cancer diagnosis. Setting: Pilot study conducted at an academic medical center breast clinic. Participant(s): Females (N = 30) who received a biopsy-proven breast cancer diagnosis without metastatic disease. Intervention (YG): One individual YP session at baseline, then 2 individual and 8 weekly group sessions followed by weekly gentle yoga at home (DVD). Questionnaires and saliva samples (ie, cortisol) completed at baseline and 12 weeks postdiagnosis. Results: Both groups reported significant improvements in QoL postintervention but with no significant difference between groups. Emotional well-being, mood-related tension-anxiety, depression-dejection, and confusion-bewilderment scores improved for both groups, and cortisol and cortisone levels decreased. Lumpectomies were prevalent with YG (67%) and CG (47%). YP was rated as “very effective,” providing relaxation (85%), stress relief (69%), and reduced muscle tension/general feeling of wellness (each 62%). Conclusion: Feasibility of YP immediately after breast cancer diagnosis was good. Improvement in emotional well-being, anxiety, depression, and levels of confusion was found in both groups. To our knowledge, this is the first study examining the impact of YP immediately after breast cancer diagnosis. Further research in this area is warranted. PMID:27257529

  13. In vivo detection of oral epithelial cancer using endogenous fluorescence lifetime imaging: a pilot human study (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Jo, Javier A.; Hwang, Dae Yon; Palma, Jorge; Cheng, Shuna; Cuenca, Rodrigo; Malik, Bilal; Jabbour, Joey; Cheng, Lisa; Wright, John; Maitland, Kristen

    2016-03-01

    Endogenous fluorescence lifetime imaging (FLIM) provides direct access to the concomitant functional and biochemical changes accompanying tissue transition from benign to precancerous and cancerous. Since FLIM can noninvasively measure different and complementary biomarkers of precancer and cancer, we hypothesize that it will aid in clinically detecting early oral epithelial cancer. Our group has recently demonstrated the detection of benign from premalignant and malignant lesions based on endogenous multispectral FLIM in the hamster cheek-pouch model. Encouraged by these positive preliminary results, we have developed a handheld endoscope capable of acquiring multispectral FLIM images in real time from the oral mucosa. This novel FLIM endoscope is being used for imaging clinically suspicious pre-malignant and malignant lesions from patients before undergoing tissue biopsy for histopathological diagnosis of oral epithelial cancer. Our preliminary results thus far are already suggesting the potential of endogenous FLIM for distinguishing a variety of benign lesions from advanced dysplasia and squamous cell carcinoma (SCC). To the best of out knowledge, this is the first in vivo human study aiming to demonstrate the ability to predict the true malignancy of clinically suspicious lesions using endogenous FLIM. If successful, the resulting clinical tool will allow noninvasive real-time detection of epithelial precancerous and cancerous lesions in the oral mucosa and could potentially be used to assist at every step involved on the clinical management of oral cancer patients, from early screening and diagnosis, to treatment and monitoring of recurrence.

  14. Changes in microflora in dental plaque from cancer patients undergoing chemotherapy and the relationship of these changes with mucositis: A pilot study.

    PubMed

    Vozza, Iole; Caldarazzo, Vito; Ottolenghi, Livia

    2015-05-01

    To assess changes in oral microflora in dental plaque from cancer patients within 7 days of the first course of chemotherapy, and the relationship of the changes with mucositis. Thirty cancer patients, divided into a test group undergoing chemotherapy and a control group no undergoing chemotherapy, were enrolled in this pilot study. Oral microflora were cultured from three samples of dental plaque at t0 (before chemotherapy), t1 (1 day after chemotherapy) and t2 (7 days after chemotherapy). Single and crossed descriptive analyses were used to establish prevalence, and the χ² test was used to establish the statistical significance of the differences observed in distributions (significance level: P<0.05). In most patients (57%), oral microflora consisted mainly of Gram-positive cocci, while the remaining 43% of the bacterial flora also had periodontal-pathogenic species. No Porphyromonas gingivalis appeared in the test group. Actinobacillus was the least frequently found bacterium among periodontal pathogens in the test group, while Fusobacterium nucleatum was the most frequently found. No significant differences were found in quantitative bacterial changes between t0, t1 and t2 in either the test or control groups, or between the two groups. According to World Health Organization scores, oral mucositis developed in 10 patients (66.6%) in the test group. The results of this pilot study indicate that there were no changes in microflora in dental plaque in cancer patients within 7 days of the first course of chemotherapy. No correlations between oral mucositis and specific microorganisms were assessed.

  15. Investigating the use of Barrows Cards to improve self-management and reduce healthcare costs in adolescents with blood cancer: a pilot study.

    PubMed

    Bagnasco, Annamaria; Calza, Simona; Petralia, Paolo; Aleo, Giuseppe; Fornoni, Laura; Sasso, Loredana

    2016-04-01

    To test if the Barrows Cards method improves adherence to immunosuppressive therapy self-management following hematopoietic stem-cell transplantation in adolescents affected by blood cancer and reduce costs. Chronically ill adolescents need to be helped to improve self-management, make sure they can confidently and safely manage therapy at home and reduce readmissions and costs. We identified the Barrows Cards method, originally used to test decision-making skills and critical thinking in medical students. In this pilot study, we tested the efficacy of the Barrows Cards Method in improving adhesion to immunosuppressive therapy in a group of adolescents following hematopoietic stem-cell transplantation and analysed its cost-effectiveness. A mixed-method study. The Barrows Cards method is an educational intervention based on the theory of problem-based learning that uses at least 15 cards specially designed to teach participants how to manage a specific problem. We piloted the Barrows cards method in terms of adherence to immunosuppressive therapy and self-management in a group of 17 adolescents affected by blood cancer before being discharged. Participants were enrolled between 2013-2015. Activity Based Costing was used to analyse the cost-effectiveness. The Barrows Cards method significantly improved adherence to immunosuppressive therapy in blood cancer adolescents and reduced readmissions. We also showed how this method could significantly reduce healthcare costs. Further research is required, but the Barrows Cards method could be effectively used by nurses to improve self-management in chronic patients and reduce health costs. © 2016 John Wiley & Sons Ltd.

  16. A pilot study of transformation, attributed meanings to the illness, and spiritual well-being for terminally ill cancer patients.

    PubMed

    Ando, Michiyo; Morita, Tatsuya; Lee, Virginia; Okamoto, Takuya

    2008-12-01

    The present study investigated what types of transformation terminally ill cancer patients experienced from diagnosis until the terminal stage, what meanings terminally ill cancer patients attributed to their illness, and whether or not those who attributed positive meaning to their illness achieved high levels of spiritual well-being as a preliminary study. Ten terminally ill cancer patients in the hospice wards of two general hospitals participated. A clinical psychologist conducted a semistructured interview with the patients individually for about 60 min. Patients completed the FACIT-Sp and HADS before the interview and talked about the meanings of cancer experience. The contents of the interviews were analyzed qualitatively. Patients were separated into high and low levels of spiritual-well being by the median of FACIT-Sp scores. Three types of transformation were extracted: "group with peaceful mind," "group with both positive attitude and uneasy feeling," and "groups with uneasy feeling." As attributed meanings to the illness, five categories were extracted: "positive meaning," "natural acceptance," "negative acceptance," "search for meaning," and "regret and sorrow." Patients in the high level spiritual well-being group attributed the meaning of illness to "positive meaning" and "natural acceptance," and those in the low level spiritual well-being group attributed it to "regret and sorrow" and "search for meaning." Some Japanese terminally ill cancer patients experienced positive transformation, and patients who attributed "positive meaning" and "natural acceptance" to their illness experience achieved high levels of spiritual well-being.

  17. Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer

    PubMed Central

    Diaz-Sanchez, Rosa-Maria; Pachón-Ibáñez, Jerónimo; Marín-Conde, Fátima; Rodríguez-Caballero, Ángela; Gutierrez-Perez, Jose-Luis

    2015-01-01

    Background To evaluate, in an initial way, the effectiveness of bioadhesive chlorhexidine gel 0.2% versus placebo as a preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy in patients diagnosed with head and neck cancer treated with chemoradiotherapy. Material and Methods In this pilot study, 7 patients (range of age: 18- 65), having histological documented diagnosis of squamous carcinoma on the head and neck region in stage III and IV, and receiving combined radiation treatment and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22, and 43 of irradiation) were studied. Simultaneously, a topical application was performed with bioadhesive chlorhexidine gel 0.2% in the study group, and the placebo gel for the control group in 5 applications per day, from the time of initiation of cancer treatment to 2 weeks after completion of chemo-radiotherapy treatment (11 weeks of follow-up). The gradation of mucositis, pain, analgesic consumption, infectious complications, and treatment tolerance was measured. Results After 7 patients completed the protocol, any differences were observed between groups in an interval analysis. Mucositis, pain, and tolerance was similar in both groups. Conclusions Our results must be interpreted with caution due to the reduced sample size, but the use of bioadhesive chlorhexidine gel 0.2% didn’t contribute clinical improvement to the oral mucositis induced by radiation therapy and chemotherapy. Key words: Chlorhexidine, mucositis, head and neck cancer. PMID:25662553

  18. [Assessment of the concentrations of carbonylated proteins and carbonyl reductase enzyme in mexican women with breast cancer: A pilot study].

    PubMed

    Gutiérrez-Salinas, José; García-Ortiz, Liliana; Mondragón-Terán, Paul; Hernández-Rodríguez, Sergio; Ramírez-García, Sotero; Núñez-Ramos, Norma Rebeca

    2016-01-01

    Oxidative stress could promote the development of cancer and implicate carbonylated proteins in the carcinogenic process. The goal of this study was to assess the concentrations of carbonylated proteins and carbonyl reductase enzyme in women with breast cancer and determine whether these markers were possible indicators of tissue damage caused by the disease. A total of 120 healthy women and 123 women with a diagnosis of breast cancer were included. The concentration of carbonylated proteins in plasma and the concentration of carbonyl reductase enzyme in leukocytes were determined using the ELISA assay. There was a 3.76-fold increase in the amount of carbonylated proteins in the plasma from the patient group compared with healthy control group (5±3.27 vs. 1.33±2.31 nmol carbonyls/mg protein; p<0.05). Additionally, a 60% increase in the carbonyl reductase enzyme was observed in the patient group compared with the healthy control group (3.27±0.124 vs. 2.04±0.11 ng/mg protein; p<0.05). A positive correlation (r=0.95; p<0.001) was found between both measurements. These results suggest the presence of tissue damage produced by cancer; therefore, these parameters could be used to indicate tissue damage in cancer patients.

  19. An Internet method to assess cancer patient information needs and enhance doctor-patient communication: a pilot study.

    PubMed

    Buzaglo, Joanne S; Millard, Jennifer L; Ridgway, Caroline G; Ross, Eric A; Antaramian, Susan P; Miller, Suzanne M; Meropol, Neal J

    2007-01-01

    We previously reported that doctor-patient communication in the cancer context may be suboptimal. We therefore developed measures to assess patient communication preferences and established feasibility of an Internet-based intervention to improve communication. Cancer patients completed an Internet-based survey about communication preferences, with a summary provided to the physician before the consultation. Patients completed a follow-up survey to assess consultation content and satisfaction. Study procedures were feasible, measures exhibited strong internal consistency, and patients expressed satisfaction with the intervention. The Internet offers an opportunity to assess patient preferences and prompt physicians about individual patient informational needs prior to the clinical encounter.

  20. Effects of Aerobic Exercise and Resistance Training on Stage I and II Breast Cancer Survivors: A Pilot Study

    ERIC Educational Resources Information Center

    Garner, Dena; Erck, Elizabeth G.

    2008-01-01

    Background: Lack of physical activity has been noted in breast cancer survivors and been attributed to decreased physical function. Purpose: This study assessed the effects of a moderate-to-vigorous physical exercise program on body fat percentage, maximal oxygen consumption (VO[subscript 2] max), body mass index, and bone mineral density (BMD) of…

  1. Treatment of pancreatic insufficiency using pancreatic extract in patients with advanced pancreatic cancer: a pilot study (PICNIC).

    PubMed

    Zdenkowski, Nicholas; Radvan, George; Pugliese, Leanna; Charlton, Julie; Oldmeadow, Christopher; Fraser, Allison; Bonaventura, Antonino

    2017-06-01

    Survival with advanced pancreatic cancer is less than 12 months. Pancreatic exocrine insufficiency may contribute to pancreatic cancer-related cachexia, via nutrient malabsorption. We aimed to determine the feasibility of prescribing pancreatic extract (Creon®) for patients with advanced pancreatic cancer. Patients with advanced pancreatic cancer, without frank malabsorption, were randomised in this feasibility study to pancreatic extract 50,000 units with meals and 25,000 units with snacks, or placebo. Standardised dietary advice was given. Anti-cancer and supportive care treatments were permitted. Outcomes included weight, body mass index (BMI), quality of life (QLQC30, PAN26), survival and nutritional assessment (PG-SGA). Eighteen patients were randomised before study closure due to slow recruitment. Baseline characteristics were well matched. Weight loss prior to randomisation was numerically greater in the pancreatic extract group (mean 0.7 vs 2.2 kg). Weight loss was numerically greater in the placebo group, however not significantly. No differences in BMI or nutrition score were seen. Quality of life did not differ between study groups. Median overall survival was 17 (95% CI 8.1-48.7) weeks in the control group, and 67.6 (95% CI 14.1-98.4) weeks in the pancreatic extract group (p = 0.1063). Only 17% (18/106) of potentially eligible patients were recruited, related to patient/family reluctance, rapid clinical deterioration and patients already prescribed pancreatic extract. A moderate pill burden was noted. Despite intriguing survival results, this study was not sufficiently feasible to proceed to a fully powered comparative study. A multi-centre study would be required to exclude a significant difference in outcomes.

  2. Using tablet-based technology in patient education about systemic therapy options for early-stage breast cancer: a pilot study

    PubMed Central

    Morgan, E.R.; Laing, K.; McCarthy, J.; McCrate, F.; Seal, M.D.

    2015-01-01

    Background Patient education in early-stage breast cancer has been shown to improve patient well-being and quality of life, but it poses a challenge given the increasingly complex regimens and time constraints in clinical practice. Technology-aided teaching in the clinic could help to improve the understanding of adjuvant systemic therapy for patients. In this prospective pilot study, we used a clinician-administered, tablet-based teaching aid to teach patients with early-stage breast cancer about adjuvant systemic therapy. Methods Participation was offered to newly diagnosed patients with early-stage breast cancer presenting for their first medical oncology visit at a provincial cancer centre. Participants were shown a tablet-based presentation describing procedures, rationales, risks, and benefits of adjuvant systemic therapy as an adjunct to a discussion with the medical oncologist. After the clinic visit, participants completed a questionnaire measuring satisfaction with the visit and knowledge of the treatment plan discussed. Results The 25 patients recruited for the study had a mean age of 57 years. An offer of upfront chemotherapy alone was made to 12 participants (48%), chemotherapy with trastuzumab to 4 (16%), and hormonal therapy to 9 (36%). Correct answers to all questions related to treatment knowledge were given by 22 patients (88%). Satisfaction with the clinic visit was high (mean satisfaction score: 4.53 ± 0.1 of a possible 5). Conclusions We found that a tablet-based presentation about adjuvant systemic therapy was satisfactory to patients with early-stage breast cancer and that knowledge retention after the clinic visit was high. Tablet-based teaching could be a feasible and effective way of educating patients in the breast oncology clinic and warrants further investigation in randomized studies. PMID:26628877

  3. Efficacy of an internet-based cognitive-behavioral intervention for long-term survivors of pediatric cancer: a pilot study.

    PubMed

    Seitz, Diana Christine Maria; Knaevelsrud, Christine; Duran, Gabriele; Waadt, Sabine; Loos, Sabine; Goldbeck, Lutz

    2014-08-01

    Long-term survivors of pediatric cancer have an increased risk of post-traumatic stress symptoms (PTSS) and dysfunctional anxiety. However, there is a lack of evidence-based psychotherapy tailored to the needs of this target group. In this single-arm pilot study, an Internet-based psychological intervention ("Onco-STEP") for adolescent and young adult survivors was developed, and its efficacy in reducing PTSS and anxiety was evaluated. Former patients of pediatric cancer older than 15 years manifesting clinically relevant PTSS or anxiety were eligible. The cognitive-behavioral treatment consists of ten writing sessions and comprises two modules: the first aiming to reprocess the traumatic cancer-related experiences and the second aiming to build coping strategies with current cancer-related fears. Treatment was delivered via written messages on a secure Internet platform. Outcomes were assessed by the Post-traumatic Stress Diagnostic Scale, the Hospital Anxiety and Depression Scale, and the Fear of Progression/Relapse Questionnaire. A total of 20 participants completed the intervention (mean age 27.3 ± 4.8 years at study; 13.8 ± 4.7 years since diagnosis; 70 % female). PTSS, anxiety, and fear of progression/relapse significantly declined at the end of the intervention, with pre-post effect sizes of 0.63, 0.74, and 0.48. In addition, we found a significant decrease in symptoms of depression. Except for the improvement in depression, all effects were sustained 3 months after the end of treatment. The results show that the intervention is efficacious in reducing symptoms of post-traumatic stress and anxiety. Onco-STEP is a promising new way to treat young adult long-term survivors of pediatric cancer with late psychological effects. Future efforts need to focus on investigating specific evidence of the intervention in a randomized controlled trial.

  4. Utilization of an Anti-Gravity Treadmill in a Physical Activity Program with Female Breast Cancer Survivors: A Pilot Study.

    PubMed

    Fairman, Ciaran M; Kendall, Kristina L; Harris, Brandonn S; Crandall, Kenneth J; McMillan, Jim

    Breast Cancer survivors can experience a myriad of physical and psychological benefits as a result of regular exercise. This study aimed to build on previous research using lower impact exercise programs by using an antigravity (Alter-G(®)) treadmill to administer cardiovascular training. The purpose of this study was to determine the effectiveness a physical activity program, including an Alter-G(®) treadmill, for improving physiological and psychosocial measures in female breast cancer survivors. A 14-week intervention using an AB-AB study design was employed. Six female breast cancer survivors were recruited to participate in the study. Participants attended three 60-minute sessions per week, consisting of a combination of muscular strength/endurance, and cardiovascular endurance exercises. Consistent with current literature and guidelines, exercise interventions were individualized and tailored to suit individuals. Data was collected and analyzed in 2013. Visual inspection of results found improvements in cardiovascular endurance and measures of body composition. Quality of life was maintained and in some cases, improved. Finally, no adverse effects were reported from the participants, and adherence to the program for those who completed the study was 97%. The results of this study suggest that the use of a physical activity program in combination with an Alter-G(®) treadmill may provide practical and meaningful improvements in measures of cardiovascular endurance and body composition.

  5. Utilization of an Anti-Gravity Treadmill in a Physical Activity Program with Female Breast Cancer Survivors: A Pilot Study

    PubMed Central

    FAIRMAN, CIARAN M.; KENDALL, KRISTINA L.; HARRIS, BRANDONN S.; CRANDALL, KENNETH J.; MCMILLAN, JIM

    2016-01-01

    Breast Cancer survivors can experience a myriad of physical and psychological benefits as a result of regular exercise. This study aimed to build on previous research using lower impact exercise programs by using an antigravity (Alter-G®) treadmill to administer cardiovascular training. The purpose of this study was to determine the effectiveness a physical activity program, including an Alter-G® treadmill, for improving physiological and psychosocial measures in female breast cancer survivors. A 14-week intervention using an AB-AB study design was employed. Six female breast cancer survivors were recruited to participate in the study. Participants attended three 60-minute sessions per week, consisting of a combination of muscular strength/endurance, and cardiovascular endurance exercises. Consistent with current literature and guidelines, exercise interventions were individualized and tailored to suit individuals. Data was collected and analyzed in 2013. Visual inspection of results found improvements in cardiovascular endurance and measures of body composition. Quality of life was maintained and in some cases, improved. Finally, no adverse effects were reported from the participants, and adherence to the program for those who completed the study was 97%. The results of this study suggest that the use of a physical activity program in combination with an Alter-G® treadmill may provide practical and meaningful improvements in measures of cardiovascular endurance and body composition. PMID:27293508

  6. Multiplex digital colour-coded barcode technology on RNA extracted from routine cytological samples of patients with non-small cell lung cancer: pilot study.

    PubMed

    Sgariglia, Roberta; Pisapia, Pasquale; Nacchio, Mariantonia; De Luca, Caterina; Pepe, Francesco; Russo, Maria; Bellevicine, Claudio; Troncone, Giancarlo; Malapelle, Umberto

    2017-04-06

    In the advanced stages of non-small cell lung cancer (NSCLC), molecular testing is often performed on archival cytological smears. The nCounter system (NanoString Technologies) is a new promising multiplex digital colour-coded barcode technology. However, its feasibility to evaluate the RNA expression of clinical relevant biomarkers on routine cytological smears is still uncertain. To this end, RNA was extracted from 12 NSCLC routine stained cytological smears, and nCounter analysis performed by using a 48-gene panel. Overall, 11/12 (92%) of the smears were adequate for the secondary analysis, fulfilling the quality check parameter analysis of nSolver software. This pilot study shows that RNA nCounter analysis is feasible on routine cytological smears preparing the field for the implementation of this technology in the routine setting.

  7. Effectiveness of interventions to increase the participation rate of gastric cancer screening in the Republic of Korea: a pilot study.

    PubMed

    Lee, Myung Ha; Lee, Yoon Young; Jung, Da Won; Park, Boyoung; Yun, E Hwa; Lee, Hoo-Yeon; Jun, Jae Kwan; Choi, Kui Son

    2012-01-01

    This study assessed the effectiveness of three intervention strategies to improve the participation rate of gastric cancer screening among people who had never undergone such screening, and those who had been screened for the disease, but not recently. It was conducted in the Ilsandong-gu District of Goyang City, Korea. The population for the current study was restricted to male residents, aged 40-65 years, who received an invitation letter to undergo gastric cancer screening from the National Health Insurance (NHI) Corporation at the beginning of 2010. The subjects were divided into two categories according to their screening history: never-screened, and ever-screened. A total of 2,065 men were eligible: 803 never-screened and 1,262 ever-screened. In each screening category they were randomly assigned to one of three intervention groups: 1) tailored telephone counseling; 2) tailored postcard reminder after tailored telephone counseling;and 3) tailored telephone counseling after tailored postcard reminder. At 3 months post-intervention, never- screened men with any intervention were more likely to undergo gastric cancer screening (OR=2.75, 95% CI: 1.22-6.18) compared to those in the reference group (no intervention). However, there was no statistically significant intervention effect in ever-screened men (OR=1.21, 95% CI: 0.65-2.27). Examination of the intervention effects by intervention group among never-screened men showed that those in the postcard reminder after telephone counseling group to be statistically significantly more likely to undergo gastric cancer screening (OR=4.49, 95% CI: 1.79-11.29) than the reference group (no intervention). Our results highlight that use of tailored postcard reminders after tailored telephone counseling is an effective method to increase participation in gastric cancer screening among men who had never been screened.

  8. A pilot study of an online cognitive rehabilitation program for executive function skills in children with cancer-related brain injury

    PubMed Central

    Kesler, Shelli R.; Lacayo, Norman J.; Jo, Booil

    2011-01-01

    Primary objectives Children with a history of cancer are at increased risk for cognitive impairments, particularly in executive and memory domains. Traditional, in-person cognitive rehabilitation strategies may be unavailable and/or impractical for many of these children given difficulties related to resources and health status. The feasibility and efficacy of implementing a computerized, home-based cognitive rehabilitation curriculum designed to improve executive function skills was examined in these children. Methods A one-arm open trial pilot study of an original executive function cognitive rehabilitation curriculum was conducted with 23 paediatric cancer survivors aged 7–19. Results Compliance with the cognitive rehabilitation program was 83%, similar to that of many traditional programs. Following the cognitive intervention, participants showed significantly increased processing speed, cognitive flexibility, verbal and visual declarative memory scores as well as significantly increased pre-frontal cortex activation compared to baseline. Conclusions These results suggest that a program of computerized cognitive exercises can be successfully implemented at home in young children with cancer. These exercises may be effective for improving executive and memory skills in this group, with concurrent changes in neurobiologic status. PMID:21142826

  9. Pilot study of a novel combination of two therapeutic vaccines in advanced non-small-cell lung cancer patients.

    PubMed

    Herrera, Zaima Mazorra; Ramos, Tania Crombet

    2014-07-01

    Cancer vaccines contain tumor antigens in a pro-inflammatory context with the purpose to generate potent antitumor immune responses. However, tumor cells develop different immunosuppressive mechanisms that limit the effectiveness of an anticancer immune response. Therefore, therapeutic vaccine treatment alone is usually not sufficient to generate tumor regression or survival improvement, especially in the advanced disease scenario in which most clinical studies have been conducted. Combining cancer vaccines with different anticancer therapies such as chemotherapy, radiotherapy and other immunotherapeutic agents has had different levels of success. However, the combination of cancer vaccines with different mechanisms of action has not been explored in clinical trials. To address this issue, the current review summarizes the main clinical and immunological results obtained with two different therapeutic vaccines used in advanced non-small-cell lung cancer patients, inducing an immune response against epidermal growth factor (CIMAvax-EGF) and NGcGM3 ganglioside (racotumomab). We also discuss preliminary findings obtained in a trial of combination of these two vaccines and future challenges with these therapies.

  10. Social inequalities and cancer: can the European deprivation index predict patients' difficulties in health care access? a pilot study.

    PubMed

    Moriceau, Guillaume; Bourmaud, Aurélie; Tinquaut, Fabien; Oriol, Mathieu; Jacquin, Jean-Philippe; Fournel, Pierre; Magné, Nicolas; Chauvin, Franck

    2016-01-05

    The European Deprivation Index (EDI), is a new ecological estimate for Socio-Economic Status (SES). This study postulates that Time-To-Treatment could be used as a cancer quality-of -care surrogate in order to identify the association between cancer patient's SES and quality of care in a French comprehensive cancer center. retrospective mono-centered cohort study. All consecutive incoming adult patients diagnosed for breast cancer (BC), prostate cancer (PC), colorectal cancer (CRC), lung cancer (LC) or sarcoma (S) were included between January 2013 and December 2013. The association of EDI and Time-To-Diagnosis (TTD), as well as Time-To-Treatment (TTT) was analyzed using a cox regression, and a strata analysis per tumor site was performed. 969 patients were included. Primitive tumor site was 505 BC (52%), 169 PC (17%), 145 LC (15%), 116 CRC (12%), and 34 S (4%). Median TTD was 1.41 months (Q1-Q3 0.5 to 3.5 months). Median TTT was 0.9 months (0.4 - 1.4). In a multivariate analysis, we identified the tumor site as a predictive factor to influence TTD, shorter for BC (0.75 months, [0.30- 1.9]) than PC (4.69 months [1.6-29.7]), HR 0.27 95%CI = [0.22-0.34], p < 0.001. TTT was also shorter for BC (0.75 months [0.4-1.1]) than PC (2.02 [0.9-3.2]), HR 0.32 95%CI = [0.27-0.39], p < 0.001. EDI quintiles were not found associated with either TTT or TTD. Deprivation estimated by the EDI does not appear to be related to an extension of the Time-to-Diagnosis or Time-to-Treatment in our real-life population. Further research should be done to identify other frailty-sensitive factors that could be responsible for delays in care.

  11. Social inequalities and cancer: can the European deprivation index predict patients' difficulties in health care access? a pilot study

    PubMed Central

    Moriceau, Guillaume; Bourmaud, Aurélie; Tinquaut, Fabien; Oriol, Mathieu; Jacquin, Jean-Philippe; Fournel, Pierre; Magné, Nicolas; Chauvin, Franck

    2016-01-01

    Context The European Deprivation Index (EDI), is a new ecological estimate for Socio-Economic Status (SES). This study postulates that Time-To-Treatment could be used as a cancer quality-of -care surrogate in order to identify the association between cancer patient's SES and quality of care in a French comprehensive cancer center. Methods retrospective mono-centered cohort study. All consecutive incoming adult patients diagnosed for breast cancer(BC), prostate cancer(PC), colorectal cancer (CRC), lung cancer(LC) or sarcoma(S) were included between January 2013 and December 2013. The association of EDI and Time-To-Diagnosis(TTD), as well as Time-To-Treatment(TTT) was analyzed using a cox regression, and a strata analysis per tumor site was performed. Results 969 patients were included. Primitive tumor site was 505 BC(52%), 169 PC(17%), 145 LC(15%), 116 CRC(12%), and 34 S(4%). Median TTD was 1.41 months (Q1-Q3 0.5 to 3.5 months). Median TTT was 0.9 months (0.4 - 1.4). In a multivariate analysis, we identified the tumor site as a predictive factor to influence TTD, shorter for BC (0.75months, [0.30- 1.9]) than PC (4.69 months [1.6-29.7]), HR 0.27 95%CI= [0.22-0.34], p < 0.001. TTT was also shorter for BC (0.75months [0.4-1.1]) than PC (2.02 [0.9-3.2]), HR 0.32 95%CI= [0.27-0.39], p < 0.001. EDI quintiles were not found associated with either TTT or TTD. Conclusions Deprivation estimated by the EDI does not appear to be related to an extension of the Time-to-Diagnosis or Time-to-Treatment in our real-life population. Further research should be done to identify other frailty-sensitive factors that could be responsible for delays in care. PMID:26540571

  12. Evaluation of a brief pilot psychoeducational support group intervention for family caregivers of cancer patients: a quasi-experimental mixed-methods study.

    PubMed

    Mahendran, Rathi; Lim, Haikel A; Tan, Joyce Y S; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok; Griva, Konstadina

    2017-01-23

    Family caregivers of cancer patients often experience an impaired quality of life (QOL) and emotional distress as a result of their caregiving duties, which may potentially influence the quality of care of their care recipients. The COPE (Caregivers of cancer Outpatients' Psycho-Education support group therapy) intervention was developed as a response to the lack of work done among family caregivers of ambulatory cancer patients in Asia. This group intervention comprised four weekly sessions simultaneously targeting psychoeducation, skills training, and supportive therapy. The present study sought to evaluate the pilot COPE intervention using both quantitative and qualitative measures. The Hospital Anxiety and Depression Scale (HADS) was used to measure both depression and anxiety, while the Caregiver QOL - Cancer (CQOLC) measured caregiver QOL. These instruments were measured at baseline pre-intervention, and immediately post-intervention. A waitlist control group design was adopted. A subset of caregivers from the intervention group were invited for a semi-structured interview post-intervention. Quantitative analyses suggest that while QOL remained stable in control group participants, intervention group participants experienced QOL improvements - both in overall QOL and in the specific domain of burden. There were no significant differences in the trajectories of depression and anxiety in both groups. Qualitative analyses suggest that this might have been a result of the intervention not only equipping participants with the relevant coping skills, but also providing a platform for emotional expression and situational reappraisal. The COPE intervention has shown some efficacy in helping family caregivers of cancer patients, but more work is required before this can be implemented. Current Controlled Trials NCT02120183 . Registered 17 April 2014. Retrospectively registered.

  13. Conducting pilot and feasibility studies.

    PubMed

    Cope, Diane G

    2015-03-01

    Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
.

  14. Framework for planning and conducting pilot studies.

    PubMed

    Smith, Lisa Janette; Harrison, Margaret B

    2009-12-01

    Researchers working with partners in home care to plan a pragmatic multicenter community-based, randomized, controlled trial for leg ulcer compression treatment realized a smaller pilot study would be necessary. Because no framework for conducting pilot studies could be found, the authors developed a framework for pilot study methodology to inform the planning of such research. To this end, an integrative literature review was conducted, guided by an explicit search strategy, retrieval procedures, and appraisal process, to identify recognized pilot study aims, processes, and methodologies used in previously reported community pilot studies. Factors influencing study inclusion were recognized pilot study aims and purposes and a concise working definition of pilot study. Methodologies used in previously conducted community pilot studies were reviewed. Although relevant published research was limited, 11 pilot studies met the inclusion criteria for this review and contained suggestions to further develop or improve plans for larger definitive trials to enable a better fit of protocols within the delivery systems and scopes of practice. Pilot research processes could be divided into two stages: early planning and pilot trial. Direction for procedures and methods was gained relative to planning for an effective pilot study regarding eligibility, recruitment and data collection, management, and analysis. The results were used to develop an organizing framework for the authors' pilot study and named the Pilot Research Process (PReP) Framework. The process was instrumental in working with the authors' research team and clinical partners in the planning of their leg ulcer treatment pilot study. This framework may provide a foundation for others to analyze or develop a pilot study methodology in planning a large-scale study.

  15. Kinesiology Taping reduces lymphedema of the upper extremity in women after breast cancer treatment: a pilot study

    PubMed Central

    Rosseger, Agnieszka; Hanuszkiewicz, Justyna; Woźniewski, Marek

    2014-01-01

    Introduction Secondary lymphedema affects approximately 40% of women treated for breast cancer and is recognized as a major problem associated with the therapy of malignant tumors. Consequently, new therapeutic methods are constantly being sought to effectively eliminate the condition. One of the new forms of edema management, especially in the initial stages of edematous development, is Kinesiology Taping (KT). Aim of the study The aim of the study was to assess the effects of KT applications on the extent of lymphedema of the upper extremity in women post cancer treatment. Material and methods The study group consisted of 28 women after axillary lymphadenectomy due to breast cancer. All the patients were diagnosed with grade I secondary lymphedema. Kinesiology Taping was applied to a total of 14 randomly selected women. The remaining 14 patients constituted a control group. The extent of lymphedema was measured using a centimeter tape and Limb Volumes Professional 5.0 software. Results A significant reduction in the extent of lymphedema (p = 0.0009) was achieved in the KT group between baseline and post-treatment assessments. No such reduction, however, was found in the control group (p = 0.36). Conclusions Kinesiology Taping applications are an effective method of early-stage edema management. Kinesiology Taping may be a safe new therapeutic option in patients who are contraindicated for the use of other methods. PMID:26327858

  16. Empowering survivors after colorectal and lung cancer treatment: Pilot study of a Self-Management Survivorship Care Planning intervention.

    PubMed

    Reb, Anne; Ruel, Nora; Fakih, Marwan; Lai, Lily; Salgia, Ravi; Ferrell, Betty; Sampath, Sagus; Kim, Jae Y; Raz, Dan J; Sun, Virginia

    2017-08-01

    This study evaluates the feasibility and acceptability of a Self-Management Survivorship Care Planning (SM-SCP) intervention in colorectal and lung cancer survivors. This is a single-group, pre- and post-mixed methods study of an advance practice nurse-driven survivorship care intervention that integrates a survivorship care plan with self-management skills coaching. Colorectal and lung cancer survivors with stage I-III disease were enrolled at 3-6 months after completing treatments, and the intervention was administered in one in-person or telephone session. Survivor outcome measures included depression, anxiety, self-efficacy, QOL, and satisfaction. Paired t-tests were used for exploratory evaluations of pre-to post-intervention score changes. Content analysis was conducted to analyze the qualitative data to describe survivors' experience with the intervention. Thirty participants (15 colorectal, 15 lung) enrolled and completed the study (73% retention). It took an average of 40 min to complete the TS/CP and 34.2 min to deliver the intervention. Exploratory analysis revealed significant differences from baseline to post-intervention in depression, anxiety, self-efficacy, physical functioning, role limitations-physical, pain, general health, health transition, physical health summary, and total QOL. Three qualitative themes emerged: 1) Feeling empowered about having a plan; 2) Struggling with psychosocial concerns; and 3) Suggestions for intervention content and delivery. The SM-SCP intervention was feasible and acceptable for colorectal and lung cancer survivors after treatment completion. Survivorship care interventions have potential to fulfill the unmet needs of colorectal and lung cancer survivors. Their effectiveness might be greater by integrating conceptually-based models of care, such as self-management skills building. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. miRNA as potential biomarkers of breast cancer in the Lebanese population and in young women: a pilot study.

    PubMed

    Nassar, Farah J; El Sabban, Maya; Zgheib, Nathalie K; Tfayli, Arafat; Boulos, Fouad; Jabbour, Mark; El Saghir, Nagi S; Talhouk, Rabih; Bazarbachi, Ali; Calin, George A; Nasr, Rihab

    2014-01-01

    Relative to western populations, the percentage of women diagnosed with breast cancer at a young age in Lebanon is high. While the younger age of the Lebanese population compared to the West certainly contributes to this difference, potential genetic, reproductive and/or biological factors likely play an important role. The objective of this study is to investigate the contribution of miRNAs in this setting through the analysis of the expression of five reported dysregulated miRNAs, miR-148b, miR-10b, miR-21, miR-221, and miR-155 in 20 normal and 57 cancerous breast tissues from Lebanese breast cancer patients. After finding their relative expression by quantitative reverse transcription real time PCR, the results were analyzed with respect to the patients' clinical and histopathology presentations. Compared to normal breast tissues, significant upregulation of miR-155, miR-21 and miR-148b, notable downregulation of miR-10b and non-significant expression of miR-221 were observed in tumor tissues. Moreover, miR-10b was significantly underexpressed in estrogen/progesterone receptor (ER/PR) negative tumors relative to ER/PR positive tumor tissues. miR-155 was also significantly overexpressed in postmenopausal patients and in those of age at diagnosis greater than 40 years old as well as in PR negative or in human epidermal growth factor 2 (Her2) positive tissues. This study is the first one to report miRNA expression patterns in Lebanese breast cancer patients. We found that differential miRNA expression in breast cancer could be variable between Lebanese and Western populations. miR-10b was positively correlated with the ER and PR status and miR-155 could be a noteworthy biomarker for the menopausal state, age at diagnosis, PR and Her2 status. Hence, miRNA can be used as biomarkers for early breast cancer detection.

  18. The effect of individualized patient education, along with emotional support, on the quality of life of breast cancer patients - A pilot study.

    PubMed

    Sajjad, Sehrish; Ali, Asho; Gul, Raisa B; Mateen, Ahmed; Rozi, Shafquat

    2016-04-01

    This study aimed to determine the effect of individualized patient education along with emotional support on the quality of life (QoL) of breast cancer patients undergoing chemotherapy. It also aimed to determine the intervention's feasibility in the Pakistani context. A quasi-experimental design, with pre- and post-test, in two groups, via time block, was used. The study was conducted at a public hospital in Karachi with a sample of 50 patients; 25 patients each in the intervention and control group. The intervention was delivered over a period of six weeks. It comprised verbal and written patient education, availability of a nurse during patients' chemotherapy administration and over the telephone, and a telephone follow-up of the patients by the nurse. patients' QoL was assessed at baseline and at the sixth week of receiving chemotherapy. Tests indicated a significant improvement in the overall QoL, breast cancer subscale scores, and the physical and emotional well-being of the intervention group, as compared to the control group. The intervention effect size was moderate (0.655) for the QoL. The intervention was found to be effective in improving patients' QoL. However, a larger study, in a multi-center setting, is recommended to ascertain the findings of this pilot study. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Tracking Viable Circulating Tumor Cells (CTCs) in the Peripheral Blood of Non-Small Cell Lung Cancer Patients Undergoing Definitive Radiation Therapy: Pilot Study Results

    PubMed Central

    Dorsey, Jay F.; Kao, Gary D.; MacArthur, Kelly M.; Ju, Melody; Steinmetz, David; Wileyto, E. Paul; Simone, Charles B.; Hahn, Stephen M.

    2014-01-01

    Background Assays identifying circulating tumor cells (CTC) allow noninvasive and sequential monitoring of the status of primary or metastatic tumors, potentially yielding clinically useful information. However, the effect of radiation therapy (RT) on CTC in patients with non-small cell lung cancer (NSCLC) to our knowledge has not been previously explored. Methods We describe here results of a pilot study of 30 NSCLC patients undergoing RT, from whom peripheral blood samples were assayed for CTC via an assay that identifies live cells, via an adenoviral probe that detects the elevated telomerase activity present in almost all cancer cells but not normal cells, and with validity of the assay confirmed with secondary tumor-specific markers. Patients were assayed prior to initiation of radiation (Pre-RT), during the RT treatment course, and/or after completion of radiation (Post-RT). Results The assay successfully detected CTC in the majority of patients, including 65% of patients prior to start of RT, and in patients with both EGFR wild type and mutation-positive tumors. Median counts in patients Pre-RT were 9.1 CTC/mL (range: undetectable - 571), significantly higher than the average Post-RT count of 0.6 CTC/mL (range: undetectable - 1.8) (p < 0.001). Sequential CTC counts were available in a subset of patients and demonstrated decreases after RT, except for a patient who subsequently developed distant failure. Conclusions These pilot data suggest that CTC counts appear to reflect response to RT for patients with localized NSCLC. Based on these promising results, we have launched a more comprehensive and detailed clinical trial. PMID:25241991

  20. The effects of yoga on shoulder and spinal actions for women with breast cancer-related lymphoedema of the arm: A randomised controlled pilot study.

    PubMed

    Loudon, Annette; Barnett, Tony; Piller, Neil; Immink, Maarten A; Visentin, Denis; Williams, Andrew D

    2016-09-02

    We aimed to evaluate the effect of an 8-week yoga intervention on the shoulder and spinal actions of women with breast cancer-related arm lymphoedema. A randomised controlled pilot trial. The intervention group (n = 12) completed eight weeks of daily yoga sessions while the control group (n = 11) continued with best current care including information on compression sleeves, skin care, risks of temperature variations and recommended safe use of affected arm. Lumbo-pelvic posture, range of motion (ROM) in the shoulder and spine, and strength in shoulder and pectoral major and minor, and serratus anterior were taken at baseline, week 8 and after a 4-week follow-up. Outcome assessors were blinded to allocation. At week eight the intervention group had an improvement in lumbo-pelvic posture, as indicated by a reduction in pelvic obliquity compared to the control group (mean difference = -8.39°, 95 % CI: -15.64 to -1.13°, p = 0.023). A secondary finding was that strength in shoulder abduction significantly increased following the yoga intervention in both the affected (9.5 kg; CI: 0.34 to 18.66, p = 0.042) and non-affected arm (11.58 kg; CI: 0.25 to 22.91; p = 0.045). There were no significant between group changes in any ROM measures as a result of the yoga intervention. This pilot study demonstrates that participation in yoga may provide benefits for posture and strength in women with Breast Cancer Related Lymphoedema. The improvements may be attributed to the focus of yoga on overall postural and functional movement patterns. Further trials with longer intervention that follow this methodology are warranted. The Australian New Zealand Clinical Trials Registry ACTRN12611000202965 .

  1. Efficacy of a Mobile-Enabled Web App (iCanFit) in Promoting Physical Activity Among Older Cancer Survivors: A Pilot Study.

    PubMed

    Hong, Yan Alicia; Goldberg, Daniel; Ory, Marcia G; Towne, Samuel D; Forjuoh, Samuel N; Kellstedt, Debra; Wang, Suojin

    2015-06-26

    The benefits of physical activity for cancer survivors are well documented. However, few older cancer survivors are engaged in regular physical activity. Mobile technologies may be an effective method to deliver physical activity promotion programs for older cancer survivors. iCanFit, a mobile-enabled Web-based app, was developed based on formative research and usability testing. This app includes interactive features of physical activity, goal setting and tracking, and receiving personalized visual feedback. The aim of this study is to pilot test the initial efficacy of iCanFit. Older cancer survivors (N=30) were recruited online through our collaborative partnership with a cancer survivor's organization. After the participants completed an online baseline survey, they were asked to use the iCanFit website. Instructional videos on how to use the web app were available on the website. Participants were asked to complete a follow-up survey 2-3 months later. Participants' physical activity, quality of life, and their experience with iCanFit were measured. A total of 30 participants completed the baseline survey, and 26 of them (87%, 26/30) also completed a follow-up survey 2-3 months later. The median age of participants was 69 years (range 60-78). Participants' quality of life and engagement in regular physical activity improved significantly after the use of iCanFit. Participants indicated a general affinity towards the key function "Goals" in iCanFit, which motivated continued activity. They also provided suggestions to further improve the app (eg, adding a reminder functionality, easier or alternative ways of entering activities). The interactive Web-based app iCanFit has demonstrated initial efficacy. Even though our study was limited by a small sample size, convenience sampling, and a short follow-up period, results suggest that using mobile tools to promote physical activity and healthy living among older cancer survivors holds promise. Next steps include

  2. "Making My Own Decisions Sometimes": A Pilot Study of Young Adult Cancer Survivors' Perspectives on Medical Decision-Making.

    PubMed

    Shay, L Aubree; Schmidt, Susanne; Cornell, Stephanie D; Parsons, Helen M

    2017-07-27

    This study aimed to provide a better understanding of the medical decision-making preferences and experiences of young adult survivors of pediatric, adolescent, and young adult cancers. We conducted key informant interviews and a cross-sectional mailed survey with young adult survivors (currently aged 18-39 years) of pediatric, adolescent, and young adult cancers in South Texas. Of the responding survivors, almost all wanted to be actively involved in medical decision-making, but preferences regarding family and doctor involvement varied. In open-ended responses, the most commonly reported concerns related to medical decision-making were feelings of uncertainty and fear of receiving bad news. Survivors reported that they desired more information in order to feel better about medical decision-making. Due to the variety of preferences regarding decision-making and who to include in the process, physicians should be prepared to ask and accommodate patients regarding their decision-making preferences.

  3. Preventive effect of rebamipide gargle on chemoradiotherpy-induced oral mucositis in patients with oral cancer: a pilot study.

    PubMed

    Yasuda, Takashi; Chiba, Hiroshige; Satomi, Takafumi; Matsuo, Akira; Kaneko, Tadayoshi; Chikazu, Daichi; Miyamatsu, Hironobu

    2012-01-01

    To assess the efficacy and safety of rebamipide in preventing chemoradiotherapy-induced oral mucositis in patients with oral cancer. Patients with oral cancer treated with chemoradiotherapy (daily radiotherapy plus docetaxel hydrate once a week) were enrolled for this study. They were assigned in a double-blind fashion to receive either rebamipide gargle or placebo on the days of chemoradiotherapy. Oral mucositis was assessed using the WHO grading system. The primary endpoint of this study was the incidence of grade 3 - 4 mucositis after exposure to 40 Gy radiation (4 weeks). The secondary endpoint was the effect of rebamipide gargle on tumour response to chemoradiotherapy. Twenty-four patients were randomly assigned to receive rebamipide gargle (n = 12) or placebo-gargle (n = 12) during chemoradiotherapy. The number of patients with severe mucositis (WHO ≥ 3) was higher in the placebo group than in the rebamipide group (83.3% vs. 33.3%, P = 0.036). In addition, no effect of rebamipide gargle on tumour response to chemoradiotherapy was recognized compared with the placebo group. For patients with oral cancer undergoing chemoradiotherapy, rebamipide gargle may contribute to decrease the severity of oral mucositis.

  4. Kinesiology Taping reduces lymphedema of the upper extremity in women after breast cancer treatment: a pilot study.

    PubMed

    Malicka, Iwona; Rosseger, Agnieszka; Hanuszkiewicz, Justyna; Woźniewski, Marek

    2014-09-01

    Secondary lymphedema affects approximately 40% of women treated for breast cancer and is recognized as a major problem associated with the therapy of malignant tumors. Consequently, new therapeutic methods are constantly being sought to effectively eliminate the condition. One of the new forms of edema management, especially in the initial stages of edematous development, is Kinesiology Taping (KT). The aim of the study was to assess the effects of KT applications on the extent of lymphedema of the upper extremity in women post cancer treatment. The study group consisted of 28 women after axillary lymphadenectomy due to breast cancer. All the patients were diagnosed with grade I secondary lymphedema. Kinesiology Taping was applied to a total of 14 randomly selected women. The remaining 14 patients constituted a control group. The extent of lymphedema was measured using a centimeter tape and Limb Volumes Professional 5.0 software. A significant reduction in the extent of lymphedema (p = 0.0009) was achieved in the KT group between baseline and post-treatment assessments. No such reduction, however, was found in the control group (p = 0.36). Kinesiology Taping applications are an effective method of early-stage edema management. Kinesiology Taping may be a safe new therapeutic option in patients who are contraindicated for the use of other methods.

  5. Is referral of postsurgical colorectal cancer survivors to cardiac rehabilitation feasible and acceptable? A pragmatic pilot randomised controlled trial with embedded qualitative study

    PubMed Central

    Hubbard, Gill; Adams, Richard; Campbell, Anna; Kidd, Lisa; Leslie, Stephen J; Munro, Julie; Watson, Angus

    2016-01-01

    Objectives (1) Assess whether cardiac rehabilitation (CR) is a feasible and acceptable model of rehabilitation for postsurgical colorectal cancer (CRC) survivors, (2) evaluate trial procedures. This article reports the results of the first objective. Design and setting A pragmatic pilot randomised controlled trial with embedded qualitative study was conducted in 3 UK hospitals with CR facilities. Descriptive statistics were used to summarise trial parameters indicative of intervention feasibility and acceptability. Interviews and focus groups were conducted and data analysed thematically. Participants People with CRC were considered for inclusion in the trial if they were ≥18 years old, diagnosed with primary CRC and in the recovery period postsurgery (they could still be receiving adjuvant therapy). 31% (n=41) of all eligible CRC survivors consented to participate in the trial. 22 of these CRC survivors, and 8 people with cardiovascular disease (CVD), 5 CRC nurses and 6 CR clinicians participated in the qualitative study. Intervention Referral of postsurgical CRC survivors to weekly CR exercise classes and information sessions. Classes included CRC survivors and people with CVD. CR nurses and physiotherapists were given training about cancer and exercise. Results Barriers to CR were protracted recoveries from surgery, ongoing treatments and poor mobility. No adverse events were reported during the trial, suggesting that CR is safe. 62% of participants completed the intervention as per protocol and had high levels of attendance. 20 health professionals attended the cancer and exercise training course, rating it as excellent. Participants perceived that CR increased CRC survivors’ confidence and motivation to exercise, and offered peer support. CR professionals were concerned about CR capacity to accommodate cancer survivors and their ability to provide psychosocial support to this group of patients. Conclusions CR is feasible and acceptable for postsurgical

  6. Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer.

    PubMed

    Diaz-Sanchez, Rosa-Maria; Pachón-Ibáñez, Jerónimo; Marín-Conde, Fátima; Rodríguez-Caballero, Ángela; Gutierrez-Perez, Jose-Luis; Torres-Lagares, Daniel

    2015-05-01

    to evaluate, in an initial way, the effectiveness of bioadhesive chlorhexidine gel 0.2% versus placebo as a preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy in patients diagnosed with head and neck cancer treated with chemoradiotherapy. In this pilot study, 7 patients (range of age: 18- 65), having histological documented diagnosis of squamous carcinoma on the head and neck region in stage III and IV, and receiving combined radiation treatment and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22, and 43 of irradiation) were studied. Simultaneously, a topical application was performed with bioadhesive chlorhexidine gel 0.2% in the study group, and the placebo gel for the control group in 5 applications per day, from the time of initiation of cancer treatment to 2 weeks after completion of chemo-radiotherapy treatment (11 weeks of follow-up). The gradation of mucositis, pain, analgesic consumption, infectious complications, and treatment tolerance was measured. After 7 patients completed the protocol, any differences were observed between groups in an interval analysis. Mucositis, pain, and tolerance was similar in both groups. Our results must be interpreted with caution due to the reduced sample size, but the use of bioadhesive chlorhexidine gel 0.2% didn't contribute clinical improvement to the oral mucositis induced by radiation therapy and chemotherapy.

  7. Massage therapy alone and in combination with meditation for breast cancer patients undergoing autologous tissue reconstruction: A randomized pilot study.

    PubMed

    Dion, Liza J; Engen, Deborah J; Lemaine, Valerie; Lawson, Donna K; Brock, Charise G; Thomley, Barbara S; Cha, Stephen S; Sood, Amit; Bauer, Brent A; Wahner-Roedler, Dietlind L

    2016-05-01

    This study explored whether massage combined with meditation is more helpful than massage alone for women recovering from autologous tissue reconstruction after mastectomy for breast cancer. Forty patients were randomly assigned to either massage therapy or massage plus meditation on postoperative days 1 through 3. Outcome measures were 1) visual analog scale (VAS) scores for stress, anxiety, relaxation, insomnia, alertness, fatigue, tension, pain, mood, and energy, and 2) Perceived Stress Scale-14 scores. Nineteen patients in each group finished the study. Preintervention and postintervention mean total VAS scores improved significantly in both groups (P < .001), but no significant difference occurred between groups.

  8. A pilot study to investigate if New Zealand men with prostate cancer benefit from a Mediterranean-style diet

    PubMed Central

    Bishop, Karen S.; Karunasinghe, Nishi; Han, Dug Yeo; Ferguson, Lynnette R.

    2015-01-01

    Carcinoma of the prostate is the most commonly diagnosed malignancy and the third leading cause of mortality in New Zealand men, making it a significant health issue in this country. Global distribution patterns suggest that diet and lifestyle factors may be linked to the development and progression of this cancer. Twenty men with diagnosed prostate cancer adhered to a Mediterranean diet, with specific adaptations, for three months. Prostate-specific antigen, C-reactive protein and DNA damage were evaluated at baseline and after three months of following the diet. Dietary data were collated from diet diaries and an adaptation of a validated Mediterranean diet questionnaire. A significant reduction in DNA damage compared to baseline was apparent, with particular benefit noted for overall adherence to the diet (p = 0.013), increased intake of folate (p = 0.023), vitamin C (p = 0.007), legumes (p = 0.004) and green tea (p = 0.002). Higher intakes of red meat and dairy products were inversely associated with DNA damage (p = 0.003 and p = 0.008 respectively). The results from this small feasibility study suggest that a high-antioxidant diet, modelled on Mediterranean traditions, may be of benefit for men with prostate cancer. Protection against DNA damage appears to be associated with the diet implemented, ostensibly due to reduction in reactive oxidant species. These findings warrant further exploration in a longer trial, with a larger cohort. PMID:26157638

  9. Treating breast cancer radiotherapy-induced moist desquamation with a traditional Chinese medicine formula: a case series pilot study.

    PubMed

    Xiaoshan, Wang; Zhixi, Li; Liang, Liang; Shuchun, Luo; Xia, Wang; Yuyi, Wang; Feng, Luo

    2014-09-01

    Abstract Objective: A case series is presented to investigate the efficacy and safety of Erhegao for patients with breast cancer who have radiotherapy-induced moist desquamation. Eighteen women with breast cancer who received radiotherapy and developed moist desquamation were enrolled. Erhegao cream, a Traditional Chinese Medicine formula consisting of zinc oxide powder, calamine powder, and lithospermum oil, was applied on areas of moist desquamation. Application was repeated once a day until healing. The primary end point for efficacy was the time to healing of the moist desquamation areas. A numerical rating scale was used to measure wound pain relief daily. Incidence of toxicity was also assessed. The average time to healing of the moist desquamation area was 13.56 days. The mean pain scores on the first, third, and seventh days were 5.22, 2.94, and 0.83, respectively. Eight-three percent of patients reported pain relief after the first 3 days, and 94%, after the first week. The mean daily reduction in the pain score was 0.40. None of the patients developed clinical infections or reported any toxicity. This formula is effective and safe, especially for pain relief, and may be an alternative treatment for radiotherapy-induced moist desquamation in patients with breast cancer. Future randomized, controlled studies are needed to better evaluate the efficacy of Erhegao cream.

  10. Serum Oxidative Stress Markers and Genotoxic Profile Induced by Chemotherapy in Patients with Breast Cancer: A Pilot Study

    PubMed Central

    Júnior, Antonio Luiz Gomes; Paz, Marcia Fernanda Correia Jardim; da Silva, Laís Iasmin Soares; Carvalho, Simone da Costa e Silva; Sobral, André Luiz Pinho; Machado, Kátia da Conceição; Ferreira, Paulo Michel Pinheiro; Satyal, Prabodh; de Freitas, Rivelilson Mendes; Cavalcante, Ana Amélia de Carvalho Melo

    2015-01-01

    The aim of this study was to evaluate the oxidative parameters of erythrocytes and genotoxicity in leukocytes of patients with breast cancer. Oxidative parameters were detected by spectrophotometry and genotoxic damage by single cell gel electrophoresis. Twenty-eight women with breast cancer were monitored before chemotherapy and after the second and fourth cycles of therapy with cyclophosphamide and doxorubicin. After the fourth cycle, increases (P < 0.05) in the reactive substances to thiobarbituric acid levels, nitrite content, and superoxide dismutase activity and high rates of DNA damage in leukocytes were observed when compared with healthy women group and baseline levels. Similarly, after the second cycle, the same parameters were increased (P < 0.05) when compared with baseline levels. Increase in catalase activity was detected only after the fourth cycle and reduced glutathione levels and glutathione peroxidase activity were decreased in all cycles when compared with healthy women, as well as after the second and fourth chemotherapy cycles compared to baseline (P < 0.05). Patients with breast cancer presented an indicative of oxidative stress before, during, and after chemotherapy, as well as increased genotoxic damage in all stages of treatment, demonstrating the clinical applicability of this investigation. PMID:26576218

  11. A pilot phase II study of neoadjuvant triplet chemotherapy regimen in patients with locally advanced resectable colon cancer

    PubMed Central

    Zhou, Haitao; Song, Yan; Jiang, Jun; Niu, Haitao; Zhao, Hong; Liang, Jianwei; Su, Hao; Wang, Zheng; Zhou, Zhixiang; Huang, Jing

    2016-01-01

    Objective This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced resectable colon cancer. Methods Patients with clinical stage IIIb colon cancer received a perioperative triple chemotherapy regimen (oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with folinic acid 200 mg, 5-fluorouracil 500 mg bolus and then 2,400 mg/m2 by 44 h infusion or capecitabine 1 g/m2 or S-1 40–60 mg b.i.d orally d 1–10, repeated at 2-week intervals) for 4 cycles. Complete mesocolic excision was scheduled 2–6 weeks after completion of neoadjuvant treatment and followed by a further 6 cycles of FOLFOXIRI or XELOX. Primary outcome measures of this stage II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment. Results All 23 patients received neoadjuvant chemotherapy and underwent surgery. Twenty-one patients (91.3%) had reductions in tumor volume after neoadjuvant treatment, and 13 patients (56.5%) had grade 3–4 toxicity. No patients had severe complications from surgery. Preoperative therapy resulted in significant down-staging of T-stage and N-stage compared with the baseline clinical stage including one pathological complete response. Conclusions Neoadjuvant triple chemotherapy has high activity and acceptable toxicity and perioperative morbidity, and is feasible, tolerable and effective for locally advanced resectable colon cancer. PMID:28174488

  12. A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain.

    PubMed

    Somers, Tamara J; Abernethy, Amy P; Edmond, Sara N; Kelleher, Sarah A; Wren, Anava A; Samsa, Greg P; Keefe, Francis J

    2015-10-01

    Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their reach is often limited because of a variety of barriers (e.g., travel, physical burden, cost, time). This study examined the feasibility and acceptability of a brief PCST intervention delivered to patients in their homes using mobile health (mHealth) technology. Pre-to-post intervention changes in pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing also were examined. Patients with a diagnosis of breast, lung, prostate, or colorectal cancer who reported persistent pain (N = 25) participated in a four-session intervention delivered using mHealth technology (videoconferencing on a tablet computer). Participants completed measures of pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing. We also assessed patient satisfaction. Participants completed an average of 3.36 (SD = 1.11) of the four intervention sessions for an overall session completion rate of 84%. Participants reported that the program was of excellent quality and met their needs. Significant preintervention to postintervention differences were found in pain, physical symptoms, psychological distress, and pain catastrophizing. The use of mHealth technology is a feasible and acceptable option for delivery of PCST for patients with cancer. This delivery mode is likely to dramatically increase intervention access for cancer patients with pain compared to traditional in-person delivery. Preliminary data also suggest that the program is likely to produce pretreatment to post-treatment decreases in pain and other important outcomes. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  13. A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients with Persistent Cancer Pain

    PubMed Central

    Somers, Tamara J.; Abernethy, Amy P.; Edmond, Sara N.; Kelleher, Sarah A.; Wren, Anava A.; Samsa, Greg P.; Keefe, Francis J.

    2015-01-01

    Context Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their reach is often limited because of a variety of barriers (e.g., travel, physical burden, cost, time). Objectives This study examined the feasibility and acceptability of a brief PCST intervention delivered to patients in their homes using mobile health (mHealth) technology. Pre-to-post intervention changes in pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing also were examined. Methods Patients with a diagnosis of breast, lung, prostate, or colorectal cancer who reported persistent pain (N=25) participated in a four-session intervention delivered using mHealth technology (video-conferencing on a tablet computer). Participants completed measures of pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing. We also assessed patient satisfaction. Results Participants completed an average of 3.36 (SD=1.11) of the four intervention sessions for an overall session completion rate of 84%. Participants reported that the program was of excellent quality and met their needs. Significant pre- to post-intervention differences were found in pain, physical symptoms, psychological distress, and pain catastrophizing. Conclusion The use of mHealth technology is a feasible and acceptable option for delivery of PCST for patients with cancer. This delivery mode is likely to dramatically increase intervention access for cancer patients with pain compared to traditional in-person delivery. Preliminary data also suggest that the program is likely to produce pre- to post-treatment decreases in pain and other important outcomes. PMID:26025279

  14. Metaphor use and health literacy: a pilot study of strategies to explain randomization in cancer clinical trials.

    PubMed

    Krieger, Janice L; Parrott, Roxanne L; Nussbaum, Jon F

    2011-01-01

    Patients often have difficulty understanding what randomization is and why it is needed in Phase III clinical trials. Physicians commonly report using metaphorical language to convey the role of chance in being assignment to treatment; however, the effectiveness of this strategy as an educational tool has not been explored. Guided by W. McGuire's (1972) information-processing model, the purpose of this pilot study was to explore effects of metaphors to explain randomization on message acceptance and behavioral intention to participate in a Phase III clinical trial among a sample of low-income, rural women (N = 64). Participants were randomly assigned to watch a video that explained randomization using 1 of 3 message strategies: a low-literacy definition, standard metaphor (i.e., flip of a coin), or a culturally derived metaphor (i.e., sex of a baby). The influence of attention on behavioral intentions to participate in clinical trials was partially moderated by message strategy. Under conditions of low attention, participants in the culturally derived metaphor condition experienced significantly higher intentions to participate in clinical trials compared with participants in the standard metaphor condition. However, as attention increased, differences in intentions among the conditions diminished. Having a positive affective response to the randomization message was a strong, positive predictor of behavioral intentions to participate in clinical trials. The authors discuss the theoretical and practical implications of these findings.

  15. SU-E-T-668: Radiosensitizing Effect of Bosutinib On Prostate and Colon Cancers: A Pilot in Vitro Study

    SciTech Connect

    Wang, B; Cvetkovic, D; Chen, L; Ma, C; Wang, C

    2015-06-15

    Purpose: Recently it has been reported that Bosutinib, a clinical kinase inhibitor, can enhance the tumor cell chemosensitivity by overriding DNA damage checkpoints. However, to the best of our knowledge, there is no report on its effect on cell radiosensitivity in the literature. The objective of the present study is to determine whether Bosutinib has the potential to be used as a radiosensitizer for various cancer cell lines. Methods: In this study, we tested 4 cell lines derived from human prostate (LNCaP, PC-3, DU-145) and colon (HT-29) cancers. The cells were seeded into 12-well plates 24 hours prior to the radiation treatments. For each cell line, we designed 4 study groups, namely, the control, Bosutinib, radiotherapy, and radiotherapy+Bosutinib groups. We used 6 MV photon beams from a Siemens Artiste accelerator to deliver 2 Gy dose in one fraction to the cells in the radiotherapy and radiotherapy+Bosutinib groups. Immediately after irradiation, the cells in the radiotherapy+Bosutinib group were treated with Bosutinib (1µM) for 3 hours. The cell survival was evaluated through clonogenic assays. Results: The cell survival rates of the LNCaP, PC-3, DU-145, and HT-29 cells were found to be 21%, 92%, 76%, and 93% for the radiotherapy group; 21%, 69%, 67%, and 81% for the radiotherapy+Bosutinib group; and 103%, 107%, 86%, and 102% for the Bosutinib group, respectively. Although synergetic cell killing was not seen for the LNCaP and DU-145 cell lines in this study, the cell survival data from the clonogenic assay indicated that Bosutinib could enhance the sensitivity of PC-3 and HT-29 cells to radiation treatment. Conclusion: Our preliminary results demonstrated the possibility of Bosutinib as a radiosensitizer for certain prostate and colon cancers, which are resistant to radiotherapy. Further studies are warranted to quantify the radiosensitizing effect of Bosutinib.

  16. A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol

    PubMed Central

    Mahendran, Rathi; Tan, Joyce Yi Siang; Griva, Konstadina; Lim, Haikel Asyraf; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok

    2015-01-01

    Introduction Despite the rising trend of cancer prevalence and increase in family caregiving, little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver samples, particularly support groups, given the benefits that have been shown in studies on Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group psychotherapy for Singaporean family caregivers of patients receiving outpatient care. Methods and analysis Facilitated by a clinical psychologist, this intervention is primarily based on the brief integrative psychological therapy with a supportive-expressive intent. Participants will be recruited while they are accompanying their care recipients for outpatient consultations. Since this is a pilot study, a sample size of 120 participants is targeted on the basis of sample sizes of previous studies. The study adopts a quasi-experimental design, as participants are assigned the intervention or control arms based on their availability to attend the intervention. A mixed methods approach is used to evaluate the outcomes of the intervention. A self-administered battery of tests is completed at four time points: baseline, postintervention and follow-up at 1-month and 2-month postinterventions; semi-structured interviews are conducted at baseline and post-intervention. Primary outcomes are quality of life and anxious and depressive symptoms; secondary outcomes are stress and basic psychological needs. Analysis using analysis of covariance would be conducted to determine the effectiveness of the intervention. Ethics and dissemination This study protocol has ethics approval from the National Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every participant. Results will be disseminated through journals and conferences, and will be particularly relevant for clinicians intending to implement similar support groups to address the

  17. Impact of a brief exercise program on the physical and psychosocial health of prostate cancer survivors: A pilot study.

    PubMed

    Skinner, Tina L; Peeters, Gmme Geeske; Croci, Ilaria; Bell, Katherine R; Burton, Nicola W; Chambers, Suzanne K; Bolam, Kate A

    2016-09-01

    It is well established that exercise is beneficial for prostate cancer survivors. The challenge for health professionals is to create effective strategies to encourage survivors to exercise in the community. Many community exercise programs are brief in duration (e.g. <5 exercise sessions); whilst evidence for the efficacy of exercise within the literature are derived from exercise programs ≥8 weeks in duration, it is unknown if health benefits can be obtained from a shorter program. This study examined the effect of a four-session individualized and supervised exercise program on the physical and psychosocial health of prostate cancer survivors. Fifty-one prostate cancer survivors (mean age 69±7 years) were prescribed 1 h, individualized, supervised exercise sessions once weekly for 4 weeks. Participants were encouraged to increase their physical activity levels outside of the exercise sessions. Objective measures of muscular strength, exercise capacity, physical function and flexibility; and self-reported general, disease-specific and psychosocial health were assessed at baseline and following the intervention. Improvements were observed in muscle strength (leg press 17.6 percent; P < 0.001), exercise capacity (400-m walk 9.3 percent; P < 0.001), physical function (repeated chair stands 20.1 percent, usual gait speed 19.3 percent, timed up-and-go 15.0 percent; P < 0.001), flexibility (chair sit and reach +2.9 cm; P < 0.001) and positive well-being (P = 0.014) following the exercise program. A four-session exercise program significantly improved the muscular strength, exercise capacity, physical function and positive well-being of prostate cancer survivors. This short-duration exercise program is safe and feasible for prostate cancer survivors and a randomized controlled trial is now required to determine whether a similar individualized exercise regimen improves physical health and mental well-being over the short, medium and long term. © 2016 John

  18. Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial

    PubMed Central

    2014-01-01

    Background Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction. These difficulties can lead to anxiety, depression and reduced quality of life. Many partners also experience psychological distress. An additional impact can be on the couple relationship, with changes to intimacy, and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation. The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention. Methods/Design The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners. Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles. Sixty-eight couples will be randomised to receive either the intervention or standard care (comprising usual follow-up hospital appointments). A pre-test, post-test design will be used to test the feasibility of the intervention (baseline, end of intervention and six-month follow-up) and its acceptability to couples and healthcare professionals (qualitative interviews). Both individual and relational outcome measures will assess sexual functioning, anxiety and depression, couple relationship, use of health services and erectile dysfunction medication/technologies. An economic analysis will estimate population costs of the intervention, compared to usual care, using simple modelling to evaluate the affordability of the intervention. Discussion Given the increasing incidence and survival of post-operative men with prostate cancer, it is timely and appropriate to determine the feasibility of a

  19. Modulation of Breast Cancer Risk Biomarkers by High-Dose Omega-3 Fatty Acids: Phase II Pilot Study in Postmenopausal Women.

    PubMed

    Fabian, Carol J; Kimler, Bruce F; Phillips, Teresa A; Nydegger, Jennifer L; Kreutzjans, Amy L; Carlson, Susan E; Hidaka, Brandon H; Metheny, Trina; Zalles, Carola M; Mills, Gordon B; Powers, Kandy R; Sullivan, Debra K; Petroff, Brian K; Hensing, Whitney L; Fridley, Brooke L; Hursting, Stephen D

    2015-10-01

    Associational studies suggest higher intakes/blood levels of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to the omega-6 arachidonic acid (AA) are associated with reduced breast cancer risk. We performed a pilot study of high-dose EPA + DHA in postmenopausal women to assess feasibility before initiating a phase IIB prevention trial. Postmenopausal women with cytologic evidence of hyperplasia in their baseline random periareolar fine needle aspiration (RPFNA) took 1,860 mg EPA +1500 mg DHA ethyl esters daily for 6 months. Blood and breast tissue were sampled at baseline and study conclusion for exploratory biomarker assessment, with P values uncorrected for multiple comparisons. Feasibility was predefined as 50% uptake, 80% completion, and 70% compliance. Trial uptake by 35 study entrants from 54 eligible women was 65%, with 97% completion and 97% compliance. Favorable modulation was suggested for serum adiponectin (P = 0.0027), TNFα (P = 0.016), HOMA 2B measure of pancreatic β cell function (P = 0.0048), and bioavailable estradiol (P = 0.039). Benign breast tissue Ki-67 (P = 0.036), macrophage chemoattractant protein-1 (P = 0.033), cytomorphology index score (P = 0.014), and percent mammographic density (P = 0.036) were decreased with favorable effects in a proteomics array for several proteins associated with mitogen signaling and cell-cycle arrest; but no obvious overall effect on proteins downstream of mTOR. Although favorable risk biomarker modulation will need to be confirmed in a placebo-controlled trial, we have demonstrated feasibility for development of high-dose EPA and DHA ethyl esters for primary prevention of breast cancer. ©2015 American Association for Cancer Research.

  20. Mature autologous dendritic cell vaccines in advanced non-small cell lung cancer: a phase I pilot study

    PubMed Central

    2011-01-01

    Background Overall therapeutic outcomes of advanced non-small-cell lung cancer (NSCLC) are poor. The dendritic cell (DC) immunotherapy has been developed as a new strategy for the treatment of lung cancer. The purpose of this study was to evaluate the feasibility, safety and immunologic responses in use in mature, antigen-pulsed autologous DC vaccine in NSCLC patients. Methods Five HLA-A2 patients with inoperable stage III or IV NSCLC were selected to receive two doses of 5 × 107 DC cells administered subcutaneous and intravenously two times at two week intervals. The immunologic response, safety and tolerability to the vaccine were evaluated by the lymphoproliferation assay and clinical and laboratorial evolution, respectively. Results The dose of the vaccine has shown to be safe and well tolerated. The lymphoproliferation assay showed an improvement in the specific immune response after the immunization, with a significant response after the second dose (p = 0.005). This response was not long lasting and a tendency to reduction two weeks after the second dose of the vaccine was observed. Two patients had a survival almost twice greater than the expected average and were the only ones that expressed HER-2 and CEA together. Conclusion Despite the small sample size, the results on the immune response, safety and tolerability, combined with the results of other studies, are encouraging to the conduction of a large clinical trial with multiples doses in patients with early lung cancer who underwent surgical treatment. Trial Registration Current Controlled Trials: ISRCTN45563569 PMID:21682877

  1. Prediction of Response to Therapy and Clinical Outcome through a Pilot Study of Complete Genetic Assessment of Ovarian Cancer

    DTIC Science & Technology

    2015-12-01

    important as nothing has been published on the molecular alternation of the different histological subtypes of ovarian cancer. 15. SUBJECT TERMS...Ovarian Cancer, histological subtypes, somatic mutations 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF...for ovarian cancer patients. Although once considered a single entity, ovarian cancer can be now subdivided into different histological subtypes

  2. Transfer Readiness Pilot Study.

    ERIC Educational Resources Information Center

    Scott-Skillman, Thelma; And Others

    The California Community Colleges (CCC) has implemented a prototype model for determining student transfer readiness as a primary means of assessing community college transfer effectiveness. This report provides definitions of transfer readiness and guidelines for colleges participating in the CCC transfer readiness study. First, a memorandum from…

  3. Speech Alarms Pilot Study

    NASA Technical Reports Server (NTRS)

    Sandor, A.; Moses, H. R.

    2016-01-01

    Currently on the International Space Station (ISS) and other space vehicles Caution & Warning (C&W) alerts are represented with various auditory tones that correspond to the type of event. This system relies on the crew's ability to remember what each tone represents in a high stress, high workload environment when responding to the alert. Furthermore, crew receive a year or more in advance of the mission that makes remembering the semantic meaning of the alerts more difficult. The current system works for missions conducted close to Earth where ground operators can assist as needed. On long duration missions, however, they will need to work off-nominal events autonomously. There is evidence that speech alarms may be easier and faster to recognize, especially during an off-nominal event. The Information Presentation Directed Research Project (FY07-FY09) funded by the Human Research Program included several studies investigating C&W alerts. The studies evaluated tone alerts currently in use with NASA flight deck displays along with candidate speech alerts. A follow-on study used four types of speech alerts to investigate how quickly various types of auditory alerts with and without a speech component - either at the beginning or at the end of the tone - can be identified. Even though crew were familiar with the tone alert from training or direct mission experience, alerts starting with a speech component were identified faster than alerts starting with a tone. The current study replicated the results from the previous study in a more rigorous experimental design to determine if the candidate speech alarms are ready for transition to operations or if more research is needed. Four types of alarms (caution, warning, fire, and depressurization) were presented to participants in both tone and speech formats in laboratory settings and later in the Human Exploration Research Analog (HERA). In the laboratory study, the alerts were presented by software and participants were

  4. Speech Alarms Pilot Study

    NASA Technical Reports Server (NTRS)

    Sandor, Aniko; Moses, Haifa

    2016-01-01

    Speech alarms have been used extensively in aviation and included in International Building Codes (IBC) and National Fire Protection Association's (NFPA) Life Safety Code. However, they have not been implemented on space vehicles. Previous studies conducted at NASA JSC showed that speech alarms lead to faster identification and higher accuracy. This research evaluated updated speech and tone alerts in a laboratory environment and in the Human Exploration Research Analog (HERA) in a realistic setup.

  5. Correlation between anthropometric parameters and acute skin toxicity in breast cancer radiotherapy patients: a pilot assessment study.

    PubMed

    Méry, Benoîte; Vallard, Alexis; Trone, Jane-Chloé; Pacaut, Cécile; Guy, Jean-Baptiste; Espenel, Sophie; Langrand-Escure, Julien; Ollier, Edouard; Wang, Guoping; Diao, Peng; Bigot, Lise; Mengue Ndong, Sylvie; Bosacki, Claire; Ben Mrad, Majed; Magné, Nicolas

    2015-01-01

    The objective of the present study was to identify acute skin toxicity risk factors linked to the anthropometric characteristics of patients with breast cancer treated with radiation therapy. Consecutive patients with breast cancer were enrolled after breast-conserving surgery and before radiotherapy course. Acute skin toxicity was assessed weekly during the 7 weeks of radiotherapy with the International Classification from National Cancer Institute. Grade 2 defined acute skin toxicity. Patient characteristics and anthropometric measurements were collected. 54 patients were enrolled in 2013. Eight patients (14.8%) had grade ≥2 toxicity. The average weight and chest size were 65.5 kg and 93.6 cm, respectively. Bra cup size is significantly associated with a risk of grade 2 dermatitis [odds ratio (OR) 3.46, 95% confidence interval (CI) (1.29-11.92), p = 0.02]. Anthropometric breast fat mass measurements, such as thickness of left [OR 2.72, 95% CI (1.08-8.26), p = 0.04] and right [OR 2.45, 95% CI (0.99-7.27), p = 0.05] axillary fat, are correlated with an increased risk. Distance between the pectoral muscle and nipple is a reproducible measurement of breast size and is associated with acute skin toxicity with significant tendency (OR = 2.21, 95% CI (0.97-5.98), p = 0.07). Breast size and its different anthropometric measurements (thickness of left and right axillary fat, nipple-to-pectoral muscle distance) are correlated with the risk of skin toxicity. The present article analyses several characteristics and anthropomorphic measurements of breast in order to assess breast size. A standardized and reproducible protocol to measure breast volume is described.

  6. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    PubMed Central

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  7. Intravenous iron monotherapy for the treatment of non-iron-deficiency anemia in cancer patients undergoing chemotherapy: a pilot study

    PubMed Central

    Abdel-Razeq, Hikmat; Abbasi, Salah; Saadi, Iyad; Jaber, Rana; Abdelelah, Hazem

    2013-01-01

    Background Anemia in patients with cancer who are undergoing active therapy is commonly encountered and may worsen quality of life in these patients. The effect of blood transfusion is often temporary and may be associated with serious adverse events. Erythropoiesis-stimulating agents are not effective in 30%–50% of patients and may have a negative effect on overall survival. Aims To assess the efficacy and feasibility of intravenous iron therapy in patients with cancer who have non-iron-deficiency anemia and who are undergoing treatment with chemotherapy without the use of erythropoiesis-stimulating agents. Methods Adult patients with solid cancers and non-iron-deficiency anemia were included. Ferric sucrose at a dose of 200 mg was given in short intravenous infusions weekly for a total of 12 weeks. Hemoglobin level was measured at baseline, every 3 weeks, and 2 weeks after the last iron infusion (week 14). Adverse events related to intravenous iron were prospectively reported. Results Of 25 patients included, 19 (76.0%) completed at least three iron infusions and 14 (56.0%) finished the planned 12 weeks of therapy. The mean hemoglobin level of the 25 patients at baseline was 9.6 g/dL (median, 9.9 g/dL; range, 6.9 g/dL 10.9 g/dL). The mean change in hemoglobin level for the 15 patients who completed at least 9 treatments was 1.7 g/dL (median, 1.1 g/dL; range, −1.9 g/dL to 3.2 g/dL); it reached 2.1 g/dL (median, 1.3 g/dL; range, −0.2 g/dL to 4.6 g/dL; P = 0.0007) for the 14 patients who completed all 12 weekly treatments. Five (20.0%) patients were transfused and considered as treatment failures. No treatment-related adverse events were reported. Conclusion Intravenous iron treatment alone is safe and may reduce blood transfusion requirements and improve hemoglobin level in patients with cancer who are undergoing anticancer therapy. Further randomized studies are needed to confirm these findings. PMID:24039403

  8. Carboplatin with Decitabine Therapy, in Recurrent Platinum Resistant Ovarian Cancer, Alters Circulating miRNAs Concentrations: A Pilot Study.

    PubMed

    Benson, Eric A; Skaar, Todd C; Liu, Yunlong; Nephew, Kenneth P; Matei, Daniela

    2015-01-01

    Plasma miRNAs represent potential minimally invasive biomarkers to monitor and predict outcomes from chemotherapy. The primary goal of the current study-consisting of patients with recurrent, platinum-resistant ovarian cancer-was to identify the changes in circulating miRNA concentrations associated with decitabine followed by carboplatin chemotherapy treatment. A secondary goal was to associate clinical response with changes in circulating miRNA concentration. We measured miRNA concentrations in plasma samples from 14 patients with platinum-resistant, recurrent ovarian cancer enrolled in a phase II clinical trial that were treated with a low dose of the hypomethylating agent (HMA) decitabine for 5 days followed by carboplatin on day 8. The primary endpoint was to determine chemotherapy-associated changes in plasma miRNA concentrations. The secondary endpoint was to correlate miRNA changes with clinical response as measured by progression free survival (PFS). Seventy-eight miRNA plasma concentrations were measured at baseline (before treatment) and at the end of the first cycle of treatment (day 29). Of these, 10 miRNAs (miR-193a-5p, miR-375, miR-339-3p, miR-340-5p, miR-532-3p, miR-133a-3p, miR-25-3p, miR-10a-5p, miR-616-5p, and miR-148b-5p) displayed fold changes in concentration ranging from -2.9 to 4 (p<0.05), in recurrent platinum resistant ovarian cancer patients, that were associated with response to decitabine followed by carboplatin chemotherapy. Furthermore, lower concentrations of miR-148b-5p after this chemotherapy regimen were associated (P<0.05) with the PFS. This is the first report demonstrating altered circulating miRNA concentrations following a combination platinum plus HMA chemotherapy regiment. In addition, circulating miR-148b-5p concentrations were associated with PFS and may represent a novel biomarker of therapeutic response, with this chemotherapy regimen, in women with recurrent, drug-resistant ovarian cancer.

  9. Preventive effects of amino-acid-rich elemental diet Elental® on chemotherapy-induced oral mucositis in patients with colorectal cancer: a prospective pilot study.

    PubMed

    Ogata, Yutaka; Ishibashi, Nobuya; Yamaguchi, Keizou; Uchida, Shinji; Kamei, Hideki; Nakayama, Goichi; Hirakawa, Hiroaki; Tanigawa, Masahiko; Akagi, Yoshito

    2016-02-01

    The prospective pilot study was designed to evaluate the preventive effects of amino-acid-rich elemental diet (ED), Elental(®), on chemotherapy-induced oral mucositis in patients with colorectal cancer. The factors influencing its efficacy are also investigated. A total of 22 eligible patients with colorectal cancer experiencing grade 1-3 oral mucositis during treatment with fluorouracil-based chemotherapy entered the current study. Their average age was 67 years. There were 10 male and 12 female. The PS was 0 in the majority of patients. Patients received two courses of the same chemotherapy regimen and Elental(®) concurrently after recovery to grade 0 or 1 oral mucositis. FOLFOX6 + bevacizumab in 8 patients, FOLFIRI + bevacizumab in 8 patients, FOLFIRI + panitumumab in 1 patient, FOLFIRI in 1 patient, XELOX + bevacizumab in 2 patients, and S-1 + cetuximab in 2 patients were used as first-line (16 cases) or as second-line (6 cases) chemotherapy. Dose reduction of 5-fluorouracil (5-FU) or oral fluoropyrimidine was performed in the 2 patients achieving grade 3 oral mucositis and in the 3 patients achieving grade 2 oral mucositis. The maximum grade of oral mucositis decreased in 18 of the 22 patients during the first treatment course with Elental(®) (p = 0.0002) and in 20 of the 22 patients in the second course (p < 0.0001). Multivariate analyses found that the dose reduction in 5-FU or oral fluoropyrimidine, ED intake, and the prior administration of ED were each a significant factor for the preventive efficacy on oral mucositis. The amino-acid-rich elemental diet Elental(®) may be useful as a countermeasure for 5-FU-based chemotherapy-induced oral mucositis in patients with colorectal cancer.

  10. Contrast-enhanced ultrasound mapping of sentinel lymph nodes in oral tongue cancer-a pilot study.

    PubMed

    Gvetadze, Shalva R; Xiong, Ping; Lv, Mingming; Li, Jun; Hu, Jingzhou; Ilkaev, Konstantin D; Yang, Xin; Sun, Jian

    2017-03-01

    To assess the usefulness of contrast-enhanced ultrasound (CEUS) with peritumoral injection of microbubble contrast agent for detecting the sentinel lymph nodes for oral tongue carcinoma. The study was carried out on 12 patients with T1-2cN0 oral tongue cancer. A radical resection of the primary disease was planned; a modified radical supraomohyoid neck dissection was reserved for patients with larger lesions (T2, n = 8). The treatment plan and execution were not influenced by sentinel node mapping outcome. The Sonovue(™) contrast agent (Bracco Imaging, Milan, Italy) was utilized. After detection, the position and radiologic features of the sentinel nodes were recorded. The identification rate of the sentinel nodes was 91.7%; one patient failed to demonstrate any enhanced areas. A total of 15 sentinel nodes were found in the rest of the 11 cases, with a mean of 1.4 nodes for each patient. The sentinel nodes were localized in: Level IA-1 (6.7%) node; Level IB-11 (73.3%) nodes; Level IIA-3 (20.0%) nodes. No contrast-related adverse effects were observed. For oral tongue tumours, CEUS is a feasible and potentially widely available approach of sentinel node mapping. Further clinical research is required to establish the position of CEUS detection of the sentinel nodes in oral cavity cancers.

  11. Gut microbial dysbiosis may predict diarrhea and fatigue in patients undergoing pelvic cancer radiotherapy: a pilot study.

    PubMed

    Wang, Aiping; Ling, Zongxin; Yang, Zhixiang; Kiela, Pawel R; Wang, Tao; Wang, Cheng; Cao, Le; Geng, Fang; Shen, Mingqiang; Ran, Xinze; Su, Yongping; Cheng, Tianmin; Wang, Junping

    2015-01-01

    Fatigue and diarrhea are the most frequent adverse effects of pelvic radiotherapy, while their etiologies are largely unknown. The aim of this study is to investigate the correlations between fatigue, diarrhea, and alterations in gut microbiota induced by pelvic radiotherapy. During the 5-week treatment of pelvic radiotherapy in 11 cancer patients, the general fatigue score significantly increased and was more prominent in the patients with diarrhea. The fatigue score was closely correlated with the decrease of serum citrulline (an indicator of the functional enterocyte mass) and the increases of systemic inflammatory proteins, including haptoglobin, orosomuoid, α1-antitrypsin and TNF-α. Serum level of lipopolysaccharide (LPS) was also elevated, especially in the patients with diarrhea indicating epithelial barrier breach and endotoxemia. Pyrosequencing analysis of 16S rRNA gene revealed that microbial diversity, richness, and the Firmicutes/Bacteroidetes ratio were significantly altered prior to radiotherapy in patients who later developed diarrhea. Pelvic radiotherapy induced further changes in fecal microbial ecology, some of which were specific to the patients with or without diarrhea. Our results indicate that gut microbial dysbiosis prior to radiation therapy may be exploited to predict development of diarrhea and to guide preventive treatment options. Radiation-induced dysbiosis may contribute to pelvic radiation disease, including mucositis, diarrhea, systemic inflammatory response, and pelvic radiotherapy-associated fatigue in cancer patients.

  12. Training-related improvements in musculoskeletal health and balance: a 13-week pilot study of female cancer survivors.

    PubMed

    Almstedt, H C; Grote, S; Perez, S E; Shoepe, T C; Strand, S L; Tarleton, H P

    2017-03-01

    Cancer survivors often experience poor post-treatment musculoskeletal health. This study examined the feasibility of combined aerobic and resistant training (CART) for improving strength, skeletal health and balance. Cancer survivors (n = 24) were identified by convenience sampling in Los Angeles County with 11 survivors consenting to 13 weeks of CART. Pre- and post-intervention assessments of bone mineral density (BMD), strength, flexibility and biomarker analysis were performed. Paired t-test analysis suggested increases in lower and upper body strength. The average T-score for BMD at the femoral neck improved from -1.46 to -1.36 and whole body BMD improved from -1.65 to -1.55. From baseline to follow-up, participants also displayed decreases in sway velocity on the eyes open (7%) and eyes closed (27%) conditions. Improvement in lower body strength was associated with increases in lean body mass (LBM) (r = 0.721) and an inverse association was observed between sway velocity and LBM (r = 0.838). Age and time since last treatment were related with biomarkers of anabolic growth (IGF-1, IGFbp-3) and bone (DPD, BAP). In summary, observed physiological changes were consistent with functional improvements, suggesting that isometric and dynamic exercise prescription may reduce the risk for falls and fall-related fractures among survivors.

  13. Porphysome nanoparticles for enhanced photothermal therapy in a patient-derived orthotopic pancreas xenograft cancer model: a pilot study

    NASA Astrophysics Data System (ADS)

    MacLaughlin, Christina M.; Ding, Lili; Jin, Cheng; Cao, Pingjiang; Siddiqui, Iram; Hwang, David M.; Chen, Juan; Wilson, Brian C.; Zheng, Gang; Hedley, David W.

    2016-08-01

    Local disease control is a major challenge in pancreatic cancer treatment, because surgical resection of the primary tumor is only possible in a minority of patients and radiotherapy cannot be delivered in curative doses. Despite the promise of photothermal therapy (PTT) for focal ablation of pancreatic tumors, this approach remains underinvestigated. Using photothermal sensitizers in combination with laser light irradiation for PTT can result in more efficient conversion of light energy to heat and improved spatial confinement of thermal destruction to the tumor. Porphysomes are self-assembled nanoparticles composed mainly of pyropheophorbide-conjugated phospholipids, enabling the packing of ˜80,000 porphyrin photosensitizers per particle. The high-density porphyrin loading imparts enhanced photonic properties and enables high-payload tumor delivery. A patient-derived orthotopic pancreas xenograft model was used to evaluate the feasibility of porphysome-enhanced PTT for pancreatic cancer. Biodistribution and tumor accumulation were evaluated using fluorescence intensity measurements from homogenized tissues and imaging of excised organs. Tumor surface temperature was recorded using IR optical imaging during light irradiation to monitor treatment progress. Histological analyses were conducted to determine the extent of PTT thermal damage. These studies may provide insight into the influence of heat-sink effect on thermal therapy dosimetry for well-perfused pancreatic tumors.

  14. A quantitative and qualitative pilot study of the perceived benefits of autogenic training for a group of people with cancer.

    PubMed

    Wright, S; Courtney, U; Crowther, D

    2002-06-01

    This paper describes the application of autogenic training (AT), a technique of deep relaxation and self-hypnosis, in patients diagnosed with cancer,with the aim of increasing their coping ability, and reports the results of a questionnaire survey performed before and after an AT course. A reduction in arousal and anxiety can help individuals to perceive their environment as less hostile and threatening, with implications for improved perceived coping ability. Complementary therapies are considered useful in enhancing symptom relief, overall well-being and self-help when used as adjuvant therapies to allopathic medical interventions. The present study aimed to validate, in an Irish context, the effectiveness of AT as a complementary therapy for patients with cancer. Each participant completed a Hospital Anxiety and Depression Scale and Profile of Mood States questionnaire before and after a 10-week AT course. The results indicated a significant reduction in anxiety and increase in 'fighting spirit' after compared with before training, with an improved sense of coping and improved sleep being apparent benefits of AT practice.

  15. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

    PubMed Central

    Metcalfe, Chris; Avery, Kerry; Berrisford, Richard; Barham, Paul; Noble, Sian M; Fernandez, Aida Moure; Hanna, George; Goldin, Robert; Elliott, Jackie; Wheatley, Timothy; Sanders, Grant; Hollowood, Andrew; Falk, Stephen; Titcomb, Dan; Streets, Christopher; Donovan, Jenny L; Blazeby, Jane M

    2016-01-01

    BACKGROUND Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. OBJECTIVES The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. DESIGN Pilot parallel three-arm randomised controlled trial nested within feasibility work. SETTING Two UK NHS departments of upper gastrointestinal surgery. PARTICIPANTS Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. INTERVENTIONS Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. MAIN OUTCOME MEASURE The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. RESULTS During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the

  16. Gastric microbiota features associated with cancer risk factors and clinical outcomes: A pilot study in gastric cardia cancer patients from Shanxi, China.

    PubMed

    Yu, Guoqin; Hu, Nan; Wang, Lemin; Wang, Chaoyu; Han, Xiao-You; Humphry, Mike; Ravel, Jacques; Abnet, Christian C; Taylor, Philip R; Goldstein, Alisa M

    2017-07-01

    Little is known about the link between gastric microbiota and the epidemiology of gastric cancer. In order to determine the epidemiologic and clinical relevance of gastric microbiota, we used 16 S ribosomal RNA gene sequencing analysis to characterize the composition and structure of the gastric microbial community of 80 paired samples (non-malignant and matched tumor tissues) from gastric cardia adenocarcinoma (GCA) patients in Shanxi, China. We also used PICRUSt to predict microbial functional profiles. Compared to patients without family history of upper gastrointestinal (UGI) cancer in the non-malignant gastric tissue microbiota, patients with family history of UGI cancer had higher Helicobacter pylori (Hp) relative abundance (median: 0.83 vs. 0.38, p = 0.01) and lower alpha diversity (median observed species: 51 vs. 85, p = 0.01). Patients with higher (vs. lower) tumor grade had higher Hp relative abundance (0.73 vs. 0.18, p = 0.03), lower alpha diversity (observed species, 66 vs. 89, p = 0.01), altered beta diversity (weighted UniFrac, p = 0.002) and significant alterations in relative abundance of five KEGG functional modules in non-malignant gastric tissue microbiota. Patients without metastases had higher relative abundance of Lactobacillales than patients with metastases (0.05 vs. 0.01, p = 0.04) in non-malignant gastric tissue microbiota. These associations were observed in non-malignant tissues but not in tumor tissues. In conclusion, this study showed a link of gastric microbiota to a major gastric cancer risk factor and clinical features in GCA patients from Shanxi, China. Studies with both healthy controls and gastric cardia and noncardia cancer cases across different populations are needed to further examine the association between gastric cancer and the microbiota. © 2017 UICC.

  17. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA

    PubMed Central

    Barton, Debra L.; Soori, Gamini S.; Bauer, Brent A.; Sloan, Jeff A.; Johnson, Patricia A.; Figueras, Cesar; Duane, Steven; Mattar, Bassam; Liu, Heshan; Atherton, Pamela J.; Christensen, Bradley; Loprinzi, Charles L.

    2014-01-01

    Purpose This pilot trial sought to investigate whether any of three doses of American ginseng (Panax quinquefolius) might help cancer-related fatigue. A secondary aim was to evaluate toxicity. Methods Eligible adults with cancer were randomized in a double-blind manner, to receive American ginseng in doses of 750, 1,000, or 2,000 mg/day or placebo given in twice daily dosing over 8 weeks. Outcome measures included the Brief Fatigue Inventory, vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36), and the Global Impression of Benefit Scale at 4 and 8 weeks. Results Two hundred ninety patients were accrued to this trial. Nonsignificant trends for all outcomes were seen in favor of the 1,000- and 2,000-mg/day doses of American ginseng. Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460–467 in the placebo group and 750 mg/day group versus 480–551 in the 1,000- and 2,000-mg/day arms, respectively. Change from baseline in the vitality subscale of the SF-36 was 7.3– 7.8 in the placebo and the 750-mg/day arm, versus 10.5– 14.6 in the 1,000- and 2,000-mg/day arms. Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo. There were no significant differences in any measured toxicities between any of the arms. Conclusion There appears to be some activity and tolerable toxicity at 1,000–2,000 mg/day doses of American ginseng with regard to cancer-related fatigue. Thus, further study of American ginseng is warranted. PMID:19415341

  18. A pilot study to compare the effect of memory training and health training interventions on affective and cognitive function with a group of cancer survivors

    PubMed Central

    McDougall, Graham J.; Becker, Heather; Acee, Taylor W.; Vaughan, Phillip W.; Delville, Carol L.

    2010-01-01

    Cancer survivors over 65 years of age experience treatment-induced memory impairments. However, clinicians are often at a loss on how to intervene for these cognitive problems. This paper describes the findings from a pilot study of a memory vs. health training intervention and its adaptability for cancer survivors. Design and Methods A convenience sample of older adults was enrolled in a longitudinal study of a memory and health training intervention and tested on five occasions for 2 years post-intervention. The memory training was designed to reduce anxiety, decrease negative attributions, promote health, and increase self-efficacy. In this analysis we included change over time for the first four of the five data collection points. We calculated means and standard deviations on the memory measures for cancer survivors in the intervention (n=8) and comparison (n=14) groups. The analysis consisted of a mixed design ANOVA comparing the two intervention groups across 4 time periods for twelve months. Results The typical cancer survivor in the sample was a 74-year old Caucasian female; 14% were minorities. Because of the small sample, some of the effects were not statistically significant. Moderate to large effects were revealed in everyday and verbal memory performance scores, memory self-efficacy, strategy use, and memory complaints. There were also moderate effects for group by time interactions on the visual memory performance measure, the memory self-efficacy measure, the depression, the trait anxiety measure, and the complaints subscale. The memory intervention group tended to improve more than the health training group, although this was not always consistent. The results suggested that the participants benefited from the memory training intervention. Implications Clinicians are often at a loss on how to intervene with cancer survivors who are experiencing cognitive problems following chemotherapy treatment. Evidenced-based interventions for this aspect of

  19. Antioxidant activity of ginger extract as a daily supplement in cancer patients receiving adjuvant chemotherapy: a pilot study

    PubMed Central

    Danwilai, Kwanjit; Konmun, Jitprapa; Sripanidkulchai, Bung-orn; Subongkot, Suphat

    2017-01-01

    Purpose The aim of this study was to examine the antioxidant activity of ginger extract oral supplement in newly diagnosed cancer patients receiving adjuvant chemotherapy compared to placebo. Patients and methods Newly diagnosed cancer patients receiving moderate-to-high emetogenic potential adjuvant chemotherapy were randomized to receive either a ginger extract (standardized 6-gingerol 20 mg/day) or a placebo 3 days prior to chemotherapy, which they continued daily. Oxidant/antioxidant parameters, including the activities of superoxide dismutase (SOD) and catalase (CAT) and levels of glutathione peroxidase (GPx), total glutathione (GSH/GSSG), lipid peroxidation products detected as malondialdehyde (MDA) and NO2−/NO3−, were measured at baseline and at days 1, 22, 43 and 64 after undergoing chemotherapy. Two-sided statistical analysis, with P < 0.05, was used to determine statistical significance. Results A total of 43 patients were included in the study: 19 and 24 patients were randomly assigned to the ginger group and placebo group, respectively. Antioxidant activity parameters, including SOD, CAT, GPx and GSH/GSSG, were significantly increased at day 64 in the ginger group compared to those in the placebo group, while MDA and NO2−/NO3− levels were significantly decreased (P < 0.0001). When compared to the baseline, the activities of SOD and CAT and the levels of GPx and GSH/GSSG were significantly higher on day 64 (P = 0.01), while the blood levels of MDA and NO2−/NO3− were significantly decreased (P < 0.01). Conclusion Daily supplement of ginger extract started 3 days prior to chemotherapy has been shown to significantly elevate antioxidant activity and reduce oxidative marker levels in patients who received moderate-to-high emetogenic potential chemotherapy compared to placebo. PMID:28203106

  20. Effects of qigong training on health-related quality of life, functioning, and cancer-related symptoms in survivors of nasopharyngeal cancer: a pilot study.

    PubMed

    Fong, Shirley S M; Ng, Shamay S M; Luk, W S; Chung, Louisa M Y; Wong, Janet Y H; Chung, Joanne W Y

    2014-01-01

    This study aimed to investigate the effects of Qigong intervention on quality of life (QOL), health-related functioning, and cancer-related symptoms in survivors of nasopharyngeal cancer (NPC). Twenty-five survivors of NPC were included in the experimental group (mean age ± SD: 55.4 ± 7.5 years) and 27 in the control group (mean age ± SD: 58.7 ± 9.5 years). The experimental group underwent a weekly 1.5-hour Qigong training program and an identical home program (three times/week) for six months. The control group received no training. Global health status/QOL, functioning, and cancer-related symptoms were assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires before training began, after three months of Qigong training, at the end of the six-month Qigong intervention (i.e., posttest), and six months posttest. Intention-to-treat analysis revealed no statistically (P > 0.05) or clinically significant improvement in global health status/QOL, functioning, or symptoms in either group. The experimental group had 45.8% fewer sense-related (smell and taste) problems (P < 0.05) but 98.6% more speech-related problems (P < 0.05) than the control group after the Qigong intervention. Qigong training resulted in no apparent improvement in health-related QOL, functionality, or cancer-related symptoms in cancer-free survivors of NPC, except for a possible reduction in smell- and taste-related problems.

  1. Effects of Qigong Training on Health-Related Quality of Life, Functioning, and Cancer-Related Symptoms in Survivors of Nasopharyngeal Cancer: A Pilot Study

    PubMed Central

    Fong, Shirley S. M.; Ng, Shamay S. M.; Luk, W. S.; Chung, Louisa M. Y.; Wong, Janet Y. H.; Chung, Joanne W. Y.

    2014-01-01

    This study aimed to investigate the effects of Qigong intervention on quality of life (QOL), health-related functioning, and cancer-related symptoms in survivors of nasopharyngeal cancer (NPC). Twenty-five survivors of NPC were included in the experimental group (mean age ± SD: 55.4 ± 7.5 years) and 27 in the control group (mean age ± SD: 58.7 ± 9.5 years). The experimental group underwent a weekly 1.5-hour Qigong training program and an identical home program (three times/week) for six months. The control group received no training. Global health status/QOL, functioning, and cancer-related symptoms were assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires before training began, after three months of Qigong training, at the end of the six-month Qigong intervention (i.e., posttest), and six months posttest. Intention-to-treat analysis revealed no statistically (P > 0.05) or clinically significant improvement in global health status/QOL, functioning, or symptoms in either group. The experimental group had 45.8% fewer sense-related (smell and taste) problems (P < 0.05) but 98.6% more speech-related problems (P < 0.05) than the control group after the Qigong intervention. Qigong training resulted in no apparent improvement in health-related QOL, functionality, or cancer-related symptoms in cancer-free survivors of NPC, except for a possible reduction in smell- and taste-related problems. PMID:24971148

  2. The NCI Digital Divide Pilot Projects: implications for cancer education.

    PubMed

    Kreps, Gary L; Gustafson, David; Salovey, Peter; Perocchia, Rosemarie Slevin; Wilbright, Wayne; Bright, Mary Anne; Muha, Cathy

    2007-01-01

    The National Cancer Institute (NCI) supported four innovative demonstration research projects, "The Digital Divide Pilot Projects," to test new strategies for disseminating health information via computer to vulnerable consumers. These projects involved active research collaborations between the NCI's Cancer Information Service (CIS) and regional cancer control researchers to field test new approaches for enhancing cancer communication in vulnerable communities. The projects were able to use computers to successfully disseminate relevant cancer information to vulnerable populations. These demonstration research projects suggested effective new strategies for using communication technologies to educate underserved populations about cancer prevention, control, and care.

  3. Assessing Heavy Metal and PCB Exposure from Tap Water by Measuring Levels in Plasma from Sporadic Breast Cancer Patients, a Pilot Study.

    PubMed

    Zimeri, Anne Marie; Robb, Sara Wagner; Hassan, Sayed M; Hire, Rupali R; Davis, Melissa B

    2015-12-09

    Breast cancer (BrCA) is the most common cancer affecting women around the world. However, it does not arise from the same causative agent among all women. Genetic markers have been associated with heritable or familial breast cancers, which may or may not be confounded by environmental factors, whereas sporadic breast cancer cases are more likely attributable to environmental exposures. Approximately 85% of women diagnosed with BrCA have no family history of the disease. Given this overwhelming bias, more plausible etiologic mechanisms should be investigated to accurately assess a woman's risk of acquiring breast cancer. It is known that breast cancer risk is highly influenced by exogenous environmental cues altering cancer genes either by genotoxic mechanisms (DNA mutations) or otherwise. Risk assessment should comprehensively incorporate exposures to exogenous factors that are linked to a woman's individual susceptibility. However, the exact role that some environmental agents (EA) play in tumor formation and/or cancer gene regulation is unclear. In this pilot project, we begin a multi-disciplinary approach to investigate the intersection of environmental exposures, cancer gene response, and BrCA risk. Here, we present data that show environmental exposure to heavy metals and PCBs in drinking water, heavy metal presence in plasma of nine patients with sporadic BrCA, and Toxic Release Inventory and geological data for a metal of concern, uranium, in Northeast Georgia.

  4. Assessing Heavy Metal and PCB Exposure from Tap Water by Measuring Levels in Plasma from Sporadic Breast Cancer Patients, a Pilot Study

    PubMed Central

    Zimeri, Anne Marie; Robb, Sara Wagner; Hassan, Sayed M.; Hire, Rupali R.; Davis, Melissa B.

    2015-01-01

    Breast cancer (BrCA) is the most common cancer affecting women around the world. However, it does not arise from the same causative agent among all women. Genetic markers have been associated with heritable or familial breast cancers, which may or may not be confounded by environmental factors, whereas sporadic breast cancer cases are more likely attributable to environmental exposures. Approximately 85% of women diagnosed with BrCA have no family history of the disease. Given this overwhelming bias, more plausible etiologic mechanisms should be investigated to accurately assess a woman’s risk of acquiring breast cancer. It is known that breast cancer risk is highly influenced by exogenous environmental cues altering cancer genes either by genotoxic mechanisms (DNA mutations) or otherwise. Risk assessment should comprehensively incorporate exposures to exogenous factors that are linked to a woman’s individual susceptibility. However, the exact role that some environmental agents (EA) play in tumor formation and/or cancer gene regulation is unclear. In this pilot project, we begin a multi-disciplinary approach to investigate the intersection of environmental exposures, cancer gene response, and BrCA risk. Here, we present data that show environmental exposure to heavy metals and PCBs in drinking water, heavy metal presence in plasma of nine patients with sporadic BrCA, and Toxic Release Inventory and geological data for a metal of concern, uranium, in Northeast Georgia. PMID:26690196

  5. A Pilot Study Assessing the Potential Role of non-CD133 Colorectal Cancer Stem Cells as Biomarkers

    PubMed Central

    Langan, Russell C.; Mullinax, John E.; Ray, Satyajit; Raiji, Manish T.; Schaub, Nicholas; Xin, Hong-Wu; Koizumi, Tomotake; Steinberg, Seth M.; Anderson, Andrew; Wiegand, Gordon; Butcher, Donna; Anver, Miriam; Bilchik, Anton J.; Stojadinovic, Alexander; Rudloff, Udo; Avital, Itzhak

    2012-01-01

    .0076). Greater expression of ALDH1A1 was associated with increasing stage (p=0.042 over stages 2, 3b, 3c, and 4) while loss of CD29 expression exhibited a trend toward being associated with stages 3 and 4 (p=0.08). Compared to normal colon tissue, primary tumors were associated with increased expression of ALDH1B1 (p=0.008). ALD1H1B1 expression level differed according to whether the tumor was moderately or poorly differentiated, well differentiated, or mucinous; the highest expression levels were associated with moderately or poorly differentiated tumors (p=0.011). Lymph node metastases were associated with a trend toward decreased expression of EpCAM (p = 0.06) when comparing 0 vs. 1 vs. 2+ positive lymph nodes, as was CD29 (p = 0.08) when comparing 0 vs. any positive lymph nodes. Compared to normal colon tissue metastatic colon cancers from different patients were associated with increased ALDH1B1 expression (p=0.001) whereas CD29 expression was higher in normal colonic tissue (p=0.014). Conclusion: CD29 may be associated with survival as well as clinical stage and number of lymph nodes. ALDH1B1 expression was associated with differentiation as well as type of tissue evaluated. ALDH1A1 was associated with clinical stage, and decreased EpCAM expression was found in patients with advanced lymph node stage. CRCSCs may be useful biomarkers to risk stratify, and estimate outcomes in CRC. Larger prospective studies are required to validate the current findings. PMID:22670157

  6. ColonCancerCheck Primary Care Invitation Pilot project

    PubMed Central

    Tinmouth, Jill; Ritvo, Paul; McGregor, S. Elizabeth; Patel, Jigisha; Guglietti, Crissa; Levitt, Cheryl A.; Paszat, Lawrence F.; Rabeneck, Linda

    2013-01-01

    Abstract Objective To describe the perceptions of those who received invitations to the ColonCancerCheck Primary Care Invitation Pilot (the Pilot) about the mailed invitation, colorectal cancer (CRC) screening in general, and their specific screening experiences. Design Qualitative study with 6 focus group sessions, each 1.5 hours in length. Setting Hamilton, Ont; Ottawa, Ont; and Thunder Bay, Ont. Participants Screening-eligible adults, aged 50 years and older, who received a Pilot invitation for CRC screening. Methods The focus groups were conducted by a trained moderator and were audiorecorded and transcribed verbatim. The transcripts were analyzed using grounded-theory techniques facilitated by the use of electronic software. Main findings Key themes related to the invitation letter, the role of the family physician, direct mailing of the fecal occult blood testing (FOBT) kit, and alternate CRC screening promotion strategies were identified. Specifically, participants suggested the letter content should use stronger, more powerful language to capture the reader’s attention. The importance of the family physician was endorsed, although participants favoured clarification of the physician and program roles in the actual mailed invitation. Participants expressed support for directly mailing FOBT kits to individuals, particularly those with successful previous test completion, and for communication of both negative and positive screening results. Conclusion This study yielded a number of important findings including strategies to optimize letter content, support for directly mailed FOBT kits, and strategies to report results that might be highly relevant to other health programs where population-based CRC screening is being considered. PMID:24336559

  7. A Pilot Study of Dose-Dense Paclitaxel With Trastuzumab and Lapatinib for Node-negative HER2-Overexpressed Breast Cancer

    PubMed Central

    Iyengar, Neil M.; Fornier, Monica N.; Sugarman, Steven M.; Theodoulou, Maria; Troso-Sandoval, Tiffany A.; D’Andrea, Gabriella M.; Drullinsky, Pamela R.; Gajria, Devika; Goldfarb, Shari B.; Comen, Elizabeth A.; Lake, Diana E.; Modi, Shanu; Traina, Tiffany A.; Lacouture, Mario E.; Chen, Melanie F.; Patil, Sujata; Baselga, José; Norton, Larry; Hudis, Clifford A.; Dang, Chau T.

    2016-01-01

    Treatment of human epidermal growth factor receptor-2 (HER2)-positive breast cancer with dual anti-HER2 therapy has been shown to improve outcomes. In the present pilot phase II study, patients with early-stage HER2-positive breast cancer received adjuvant treatment with dose-dense paclitaxel, trastuzumab, and lapatinib. However, this combination was not feasible because of unexpected toxicity. Background Dual anti-HER2 therapy is effective for HER2-amplified breast cancer. Weekly paclitaxel, trastuzumab, and full-dose lapatinib (PTL) is not feasible because of grade 3 diarrhea. We conducted a phase II feasibility study of dose-dense (DD; every other week) PTL (ClinicalTrials.gov identifier, NCT01827163). Patients and Methods Eligible patients had HER2-positive breast cancer, tumor size ≤ 3 cm, and negative nodes. Treatment included paclitaxel (175 mg/m2 × 4, every 2 weeks with pegfilgrastim), trastuzumab (4 mg/kg load and then 2 mg/kg weekly), and lapatinib (1000 mg daily). After paclitaxel × 4, trastuzumab (6 mg/kg every 3 weeks) plus lapatinib were continued for 1 year. The primary endpoint was feasibility, defined as (1) > 80% of patients completing PTL without a dose delay or reduction, (2) grade 3 diarrhea rate < 20%, and (3) cardiac event rate < 4%. Results From May 2013 to November 2013, we enrolled 20 of 55 planned patients. The median age was 49 years (range, 34–74 years). One patient had immediate paclitaxel hypersensitivity and was deemed inevaluable. Only 13 of 19 evaluable patients (68%) completed PTL without a dose delay or reduction or unacceptable toxicities. Only 3 of 19 (16%) had grade 3 diarrhea. Rash was frequent, with all grades in 18 of 19 (95%) and grade 3 in 2 of 19 (11%). The study was stopped early because of excess toxicity. Conclusion The discontinuation rate during DD PTL was high, owing, in part, to an unexpectedly high incidence of rash. The trial was halted, because the initial discontinuation rate from overall toxicity made

  8. Association of Helicobacter pylori infection with chemotherapy-induced thrombocytopenia in patients with stage III colon cancer: a pilot study.

    PubMed

    Tanriverdi, Ozgur

    2014-01-01

    In this study, the effects of the pre-treatment presence of Helicobacter pylori (H. pylori) infection on chemotherapy-induced thrombocytopenia (CIT) were investigated in patients with stage III colon cancer (CC). A cohort of 74 patients with early stage CC was analysed through a review of clinical records and personal interviews. Helicobacter pylori infections were diagnosed in these patients prior to chemotherapy. The subjects were divided into two groups according to H. pylori infection status: Group 1, H. pylori-positive and Group 2, H. pylori-negative. In all patients, bone marrow toxicity and other study variables were compared. Helicobacter pylori infections were detected in 31 of the 74 CC patients. Helicobacter pylori-infected patients (Group 1) showed significantly higher incidences of CIT than did non-infected patients (Group 2; p = 0.029). Helicobacter pylori infection status correlated significantly with tumour location (r = 0.547; p = 0.043) and the most common location of CC in H. pylori-infected patients was the ascending colon (n = 13, 42%) in comparison to non-infected patients (n = 6, 14%; p= 0.042). The relationship between CIT and H. pylori infection status in CC was determined to be independent from the other study variables (p = 0.037; OR = 3.32, CI 95% = 1.16-9.70). In this study, the small number of patients resulted in an inadequate demonstration of the relationship between H. pylori infection and CIT. Therefore, clinical and molecular studies that include more patients are warranted.

  9. Brief report: A Pilot Study of a Web-based Resource for Families of Children with Cancer

    PubMed Central

    Long, Kristin; Rotondi, Armando; Howe, Chelsea; Bill, Lauren; Marsland, Anna L.

    2009-01-01

    Objective To develop a Web-based resource for families of children newly diagnosed with cancer and examine the viability of this modality of providing support. Methods Twenty-one children (8–17 years) newly diagnosed with cancer and their families were enrolled. Quantitative data on Web site utilization and frequency of accessing specific sections and qualitative data on participant satisfaction are reported. Results Twenty-one families comprising 51 participants (children with cancer, parents, and siblings) had access to the Web site. Utilization was lower than anticipated, with members of only nine families accessing the site. The majority of these hits were on peer discussion groups. Conclusion Further research is warranted to examine whether the Internet is a viable method of delivering support to families affected by childhood cancer. The current pattern of results suggests that the timing of its introduction and the method used to train families may affect utilization. PMID:18784185

  10. A Pilot Study of Estradiol Followed by Exemestane for Reversing Endocrine Resistance in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer

    PubMed Central

    Stopeck, Alison; Clarke, Kathryn; Livingston, Robert

    2014-01-01

    Background. Endocrine resistance is a frequent complication, and strategies to reverse it are a high research priority for metastatic breast cancer (MBC) that is hormone receptor positive. Preclinical data suggest re-exposure to estrogen induces tumor regression in tamoxifen-resistant tumors. We conducted a pilot study to determine whether short-term estradiol exposure would reverse endocrine resistance and resensitize tumors Methods. Postmenopausal women with estrogen receptor-positive MBC whose disease had progressed after receiving at least one prior endocrine therapy were eligible for the study. Patients were initially treated with 6 mg/day estradiol, and those who had not progressed after 3 months were then switched to exemestane. Results. Thirteen patients were evaluable for toxicity and response. No grade 3 or 4 toxicities were observed. Of the 13 patients who initiated estradiol therapy, 6 patients (46%) had not experienced disease progression at month 3 and were switched to exemestane. On exemestane, disease progression was documented in five patients, with one having stable disease as best response. Median progression-free survival for all patients was 4.8 months (range: 0.6–9.5 months). Conclusion. Treatment with an estrogen prior to resuming antiestrogen treatments was not effective at reversing hormone resistance; however, low-dose estradiol treatment had measurable clinical activity with minimal toxicity and should be considered as a therapeutic option for hormone-refractory MBC. PMID:25260365

  11. [Re-entrainment to physical activity in the global management of breast cancer: pilot study in a mono-institutional experience].

    PubMed

    Sorg, Marine; Trone, Jane-Chloé; Méry, Benoîte; Guichard, Jean-Baptiste; Rivoirard, Romain; Pacaut, Cécile; Guy, Jean-Baptiste; Eddekkaoui, Houda; Collard, Olivier; Bosacki, Claire; Jacquin, Jean-Philippe; Guy, Jean-Michel; Magné, Nicolas

    2014-01-01

    The objective of the present study is to report the pilot experience at the "Loire cardiorespiratory readaptation center" of re-entrainment of physical activity for patients suffering from breast cancer. Between January 2012 and February 2013, 63 patients took the program at the readaptation center. The program is composed of three sessions a week during seven weeks. During the care, a medical team intervenes. It is composed of a cardiologist, a physiotherapist, a sophrologist, a psychologist and a dietician who take part in turns and/or together. During the first session of the program, the warm-up power chosen on the exercise bike was on average of 14.72 watts (min = 5; max = 30), and it went up to 44.84 watts (min = 15; max = 85) on average during the last session. The maximal power used by the patient was on average of 39.08 watts (min = 10; max = 70) during the first session. On the last day of training, the average maximal power between the patients was of 76.03 watts (min = 30; max = 110). The tests used into practice tend to confirm a physical progression between the beginning and the end of the re-training program. This study particularly shows that it is possible today to propose this type of program to the patients in daily practice.

  12. Is"chemobrain" a transient state? A prospective pilot study among persons with non-small cell lung cancer.

    PubMed

    Whitney, Kriscinda A; Lysaker, Paul H; Steiner, Amy R; Hook, Julie N; Estes, Deborah D; Hanna, Nasser H

    2008-01-01

    In patients with stage III non-small cell lung cancer (NSCLC), chemotherapy combined with radiation therapy modestly improves survival when compared with radiotherapy alone. In light of the small survival benefit,there is a need to quantify any potential loss of neurocognitive function that may result from chemotherapy in this patient population. The current study examines cognitive functioning in 14 stage III NSCLC patients who received treatment with cisplatin/etoposide/radiotherapy. Patients were assessed before receiving chemotherapy and at 1 and 7 months after treatment. At each time point, participants were administered a comprehensive battery of psychological and neuropsychological tests. In all, 71% of patients demonstrated cognitive impairment prior to any treatment. One month post chemotherapy, the majority of patients (62%) experienced cognitive decline; however, these negative effects apparently dissipated by 7 months post treatment, suggesting that the untoward effects of chemotherapy in these specific patients given this chemotherapy regimen may have been transitory. Cognitive decline did not appear to be associated with age, mood, fatigue, or quality-of-life measures. These findings demonstrated the importance of employing both a pre- and extended post-treatment assessment in chemotherapy research.

  13. Reconstruction of anterior floor of mouth defects by the local mandible myofascial flap following cancer ablation: a pilot study.

    PubMed

    Chen, Wei; Dong, Zhen; Cao, Gang; Liu, Bingyao; Meng, Zhaoye; Zhang, Senlin

    2013-09-01

    The purpose of this study is to review our experience with the use of the local mandible myofascial (LMM) flap for anterior floor of mouth (AFOM) reconstruction following cancer ablation to assess its reliability, associated complications and functional results. This is a retrospective analysis of 13 LMM flaps (nine patients) performed for AFOM reconstruction from March 2010 to June 2012. All patients underwent surgical resection and immediate reconstruction with LMM flaps. They were followed up for 3-30 months to evaluate the survival rate of the flaps, mobility of tongue and aesthetic outcome of the lower lip and mental region. All the flaps were successfully transferred. No obvious complications were found in either the AFOM or the donor region. The majority of patients resumed to a regular diet (89%, 8/9) and speech was considered as functional and/or understandable by the surgeon in all of the patients. Dental restoration was successful for 89% (8/9) of the patients. The shape and motion of the lower lip and the mental region of all patients were acceptable. The LMM flap is well suited for AFOM reconstruction because it is reliable, has few significant complications and allows preservation of oral function. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  14. Pilot Study on MAGE-C2 as a Potential Biomarker for Triple-Negative Breast Cancer.

    PubMed

    Zhao, Qian; Xu, Wen-Ting; Shalieer, Tuluhong

    2016-01-01

    Objective. In the current study, we measured the expression status of melanoma antigen gene c2 (MAGE-C2) in triple-negative breast cancer (TNBC) and analyzed its prognostic with the clinical pathological features of patients with TNBC. Methods. The expressions statuses of MAGE-C2 were detected in TNBC tissues and paracarcinoma tissues by immunohistochemistry, reverse transcription-polymerase chain reaction (RT-PCR), and western blotting. Then, we investigated the relationship of MAGE-C2 expression status and clinicopathological parameters of TNBC patients by the chi-squared test. Finally, we discussed the relations of MAGE-C2 expression state and prognosis of patients with TNBC by Kaplan-Meier method and Cox proportional hazards model. Results. High MAGE-C2 expression was found in 38.18% (42/110) of TNBC tissues. In adjacent tissues it was 9.09% (10/110). High MAGE-C2 expression in TNBC patients was closely associated with lymph node status, tumor node metastasis (TNM) stage, and lymphovascular invasion (P < 0.001). TNBC patients with high MAGE-C2 expression had significantly shorter survival time than low expression patients. We also found that age, lymph node status, TNM stage, lymphovascular invasion, and MAGE-C2 expression status were closely associated with overall survival of TNBC patients (P < 0.05). Conclusion. High MAGE-C2 expression may serve as an independent prognostic factor for TNBC patients.

  15. A novel method to evaluate salivary flow rates of head and neck cancer patients after radiotherapy: a pilot study.

    PubMed

    Palma, Luiz Felipe; Gonnelli, Fernanda Aurora Stabile; Marcucci, Marcelo; Giordani, Adelmo José; Dias, Rodrigo Souza; Segreto, Roberto Araújo; Segreto, Helena Regina Comodo

    2017-03-25

    The procedure used to evaluate salivary flow rate is called sialometry. It can be performed through several techniques, but none appears to be really efficient for post-radiotherapy patients. To adequate sialometry tests for head and neck cancer patients submitted to radiotherapy. 22 xerostomic patients post-radiotherapy (total radiation dose ranging from 60 to 70Gy) were included in this study. Ten patients were evaluated using sialometries originally proposed by the Radiation Therapy Oncology Group and twelve were assessed by our modified methods. Unstimulated and stimulated sialometries were performed and the results were classified according a grading scale and compared between both groups. There was no statistically significant difference between the salivary evaluations of both groups (p=0.4487 and p=0.5615). Also, most of these rates were classified as very low and low. This novel method seems to be suitable for patients submitted to radiotherapy. Copyright © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  16. Pilot Study on MAGE-C2 as a Potential Biomarker for Triple-Negative Breast Cancer

    PubMed Central

    Zhao, Qian; Xu, Wen-ting

    2016-01-01

    Objective. In the current study, we measured the expression status of melanoma antigen gene c2 (MAGE-C2) in triple-negative breast cancer (TNBC) and analyzed its prognostic with the clinical pathological features of patients with TNBC. Methods. The expressions statuses of MAGE-C2 were detected in TNBC tissues and paracarcinoma tissues by immunohistochemistry, reverse transcription-polymerase chain reaction (RT-PCR), and western blotting. Then, we investigated the relationship of MAGE-C2 expression status and clinicopathological parameters of TNBC patients by the chi-squared test. Finally, we discussed the relations of MAGE-C2 expression state and prognosis of patients with TNBC by Kaplan-Meier method and Cox proportional hazards model. Results. High MAGE-C2 expression was found in 38.18% (42/110) of TNBC tissues. In adjacent tissues it was 9.09% (10/110). High MAGE-C2 expression in TNBC patients was closely associated with lymph node status, tumor node metastasis (TNM) stage, and lymphovascular invasion (P < 0.001). TNBC patients with high MAGE-C2 expression had significantly shorter survival time than low expression patients. We also found that age, lymph node status, TNM stage, lymphovascular invasion, and MAGE-C2 expression status were closely associated with overall survival of TNBC patients (P < 0.05). Conclusion. High MAGE-C2 expression may serve as an independent prognostic factor for TNBC patients. PMID:27843173

  17. 90% Compliance Pilot Studies Final Report

    SciTech Connect

    2013-06-01

    In early 2010, the U.S. Department of Energy (DOE) announced an opportunity for states to participate in energy code compliance evaluation pilot studies. DOE worked with five Regional Energy Efficiency Organizations (REEOs, formerly referred to as Energy Efficiency Partnerships, or EEPs) to fund pilot studies covering nine states. This report details conclusions stated in individual state reports, as well as conclusions drawn by DOE based on their oversight of the pilot studies, and based on discussions held with the REEOs and representatives from the pilot study states and their contractors.

  18. Biofeedback Therapy Before Ileostomy Closure in Patients Undergoing Sphincter-Saving Surgery for Rectal Cancer: A Pilot Study

    PubMed Central

    Kim, Jeong-Ki; Jeon, Byeong Geon; Song, Yoon Suk; Seo, Mi Sun; Kwon, Yoon-Hye; Park, JI Won; Ryoo, Seung-Bum; Jeong, Seung-Yong

    2015-01-01

    Purpose This study prospectively investigated the effects of biofeedback therapy on objective anorectal function and subjective bowel function in patients after sphincter-saving surgery for rectal cancer. Methods Sixteen patients who underwent an ileostomy were randomized into two groups, one receiving conservative management with the Kegel maneuver and the other receiving active biofeedback before ileostomy closure. Among them, 12 patients (mean age, 57.5 years; range, 38 to 69 years; 6 patients in each group) completed the study. Conservative management included lifestyle modifications, Kegel exercises, and medication. Patients were evaluated at baseline and at 1, 3, 6, and 12 months after ileostomy closure by using anal manometry, modified Wexner Incontinence Scores (WISs), and fecal incontinence quality of life (FI-QoL) scores. Results Before the ileostomy closure, the groups did not differ in baseline clinical characteristics or resting manometric parameters. After 12 months of follow-up, the biofeedback group demonstrated a statistically significant improvement in the mean maximum squeezing pressure (from 146.3 to 178.9, P = 0.002). However, no beneficial effect on the WIS was noted for biofeedback compared to conservative management alone. Overall, the FI-QoL scores were increased significantly in both groups after ileostomy closure (P = 0.006), but did not differ significantly between the two groups. Conclusion Although the biofeedback therapy group demonstrated a statistically significant improvement in the maximum squeezing pressure, significant improvements in the WISs and the FI-QoL scores over time were noted in both groups. The study was terminated early because no therapeutic benefit of biofeedback had been demonstrated. PMID:26361615

  19. A pilot study using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) as a clinical care tool to identify lower extremity lymphedema in gynecologic cancer survivors.

    PubMed

    Carter, Jeanne; Raviv, Leigh; Appollo, Kathleen; Baser, Raymond E; Iasonos, Alexia; Barakat, Richard R

    2010-05-01

    This study aimed to determine the feasibility and efficacy of using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) as a symptom scale for lymphedema of the lower extremity (LLE). Twenty-eight gynecologic cancer survivors with documented LLE and 30 without a history or presence of lymphedema completed the GCLQ and provided feedback about their satisfaction with and feasibility of using the GCLQ at their oncology follow-ups. The study survey took approximately 5-10 min to complete, and it was easily understood by the majority of the sample. Participants had a mean age of 59.6 years (range, 28-80 years). Twenty-eight women (48%) had LLE, and 30 (52%) had no history or presence of LLE (confirmed by limb volume [LV] measurements at assessment). Type of cancer history included endometrial, 38 (66%); cervical, 13 (22%); and vulvar, 7 (12%). GCLQ scores differed significantly by lymphedema diagnosis; LLE patients had higher scores (P<0.01). The large area under the curve (AUC) of 0.95 (95% CI: 0.90-1.000) suggests that the GCLQ can distinguish between patients with and without LLE. Although all 28 (100%) of the LLE patients were aware of their LLE diagnosis, only 23 (82%) underwent treatment. The GCLQ was easily understood by most (55/58, 95%), and overall, patients showed a high willingness (56/58, 96%) to complete the questionnaire at future appointments. Twenty-five (88%) of the LLE patients found the GCLQ to be helpful in identifying symptoms of lymphedema. The GCLQ effectively distinguished between gynecologic cancer survivors with and those without LLE, with good sensitivity and specificity. The patients, particularly those with LLE, showed high confidence in the GCLQ's ability to detect LLE symptoms. Copyright (c) 2010 Elsevier Inc. All rights reserved.

  20. Will More Diversified Staffs Diversify Newspaper Content? A Pilot Study.

    ERIC Educational Resources Information Center

    Fedler, Fred; and Others

    A pilot study asked 94 students enrolled in introductory newswriting classes at three separate universities to evaluate 18 news stories. About half the stories concerned topics that proponents of multiculturalism have suggested would receive more emphasis if newspapers employed more women and minorities: topics such as breast cancer, divorce,…

  1. Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training.

    PubMed

    Kristanti, Martina Sinta; Setiyarini, Sri; Effendy, Christantie

    2017-01-17

    Palliative care in Indonesia is problematic because of cultural and socio-economic factors. Family in Indonesia is an integral part of caregiving process in inpatient and outpatient settings. However, most families are not adequately prepared to deliver basic care for their sick family member. This research is a pilot project aiming to evaluate how basic skills training (BST) given to family caregivers could enhance the quality of life (QoL) of palliative care cancer patients in Indonesia. The study is a prospective quantitative with pre and post-test design. Thirty family caregivers of cancer patients were trained in basic skills including showering, washing hair, assisting for fecal and urinary elimination and oral care, as well as feeding at bedside. Patients' QoL were measured at baseline and 4 weeks after training using EORTC QLQ C30. Hypothesis testing was done using related samples Wilcoxon Signed Rank. A paired t-test and one-way ANOVA were used to check in which subgroups was the intervention more significant. The intervention showed a significant change in patients' global health status/QoL, emotional and social functioning, pain, fatigue, dyspnea, insomnia, appetite loss, constipation and financial hardship of the patients. Male patient's had a significant effect on global health status (qol) (p = 0.030); female patients had a significant effect on dyspnea (p = 0.050) and constipation (p = 0.038). Younger patients had a significant effect in global health status/QoL (p = 0.002). Patients between 45 and 54 years old had significant effect on financial issue (p = 0.039). Caregivers between 45 and 54 years old had significant effect on patients' dyspnea (p = 0.031). Basic skills training for family caregivers provided some changes in some aspects of QoL of palliative cancer patients. The intervention showed promises in maintaining the QoL of cancer patients considering socio-economic and cultural challenges in the provision of

  2. Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study

    PubMed Central

    Tamblyn, Robyn; Meterissian, Sarkis; Law, Susan; Prchal, Jaroslav; Winslade, Nancy; Stern, Donna

    2016-01-01

    Background In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. Objectives The objectives of the study are to determine the effectiveness of a patient-specific, real-time eHealth alert delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation as well as to assess integration of eHealth alerts regarding deviations from best practices in administration of AET by cancer care teams. Methods A prospective, 2-group controlled comparison pilot study will be conducted at 2 urban, McGill University–affiliated hospitals, the Royal Victoria Hospital and St. Mary’s Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Health care professionals at the intervention site will have access to the eHealth tool, which will report to them in real-time medical events with known associations to AET discontinuation, an AET adherence monitor, and a discontinuation alert. Cox proportional hazard ratios with 95% confidence intervals will estimate risks of AET discontinuation. Tests for significance will be 2-sided with a significance level of P<.05. Results This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence and assess care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data ready to present by June 2018. Conclusion This study will offer an opportunity to

  3. Arsenic exposure and human papillomavirus response in non-melanoma skin cancer Mexican patients: a pilot study.

    PubMed

    Rosales-Castillo, J Alberto; Acosta-Saavedra, Leonor C; Torres, Rosantina; Ochoa-Fierro, Jesús; Borja-Aburto, Víctor H; Lopez-Carrillo, Lizbeth; Garcia-Vargas, Gonzalo G; Gurrola, Georgina B; Cebrian, Mariano E; Calderón-Aranda, Emma S

    2004-08-01

    We assessed the relationships between chronic arsenic (As) exposure, human papilloma virus (HPV) contact and non-melanoma skin cancer (NMSC) by means of a dermatology clinic-based case-control study (42 cases and 48 controls) in Region Lagunera, Mexico, where chronic As poisoning is endemic. Exposure was determined through detailed history of residence in the As-contaminated area and measurement of As levels in drinking water and urine. We used a consensus epitope from the central region of L1 protein of the HPV family to determine antibodies against HPV. A history of As exposure and HPV seropositivity were associated with increased NMSC risks. A history of exposure to high levels of As increased the risk for NMSC (OR = 4.53; P = 0.11) in the group of seronegative HPV patients. A positive response to HPV significantly increased the OR for NMSC to 9.04 (P = 0.01) when history showed exposure to low levels of As. Interestingly, the OR was significantly increased to 16.5 (P = 0.001) when both exposure to high levels of As and HPV seropositivity were present. In addition, the presence of NMSC increased the OR (5.45; P = 0.03) for a positive response to HPV when history showed exposure to low levels of As, but the OR was increased to 8.0 (P = 0.005) in the cases with high exposure levels. Thus, HPV infection could constitute an additional risk factor for NMSC development in humans chronically exposed to As. However, further studies with additional populations are needed to determine the interaction between HPV and As exposure in NMSC.

  4. A pilot study to identify correlates of intentional versus unintentional nonadherence to analgesic treatment for cancer pain.

    PubMed

    Meghani, Salimah H; Bruner, Deborah Watkins

    2013-06-01

    Existing studies of medication adherence treat "nonadherence" as a monolithic concept. The goal of this study was to isolate correlates of intentional versus unintentional nonadherence for analgesic treatment for cancer pain. Patients were recruited from outpatient oncology clinics in the middle Atlantic region, ≥18 years old, and diagnosed with solid tumors, and had an active prescription of at least one around-the-clock analgesic. The Morisky Medication Adherence Scale (MMAS) was used to assesses "unintentional" (forgetfulness/carelessness) and "intentional" (stopping use of medication if feeling better or worse) dimensions of analgesic nonadherence. A visual analog scale was used to assess the percentage of analgesic doses taken in the preceding month. A majority of participants (85.5%) took prescribed analgesics in the index period. However, 51% reported taking only up to 60% of the analgesic doses prescribed to them. Stopping taking analgesics when feeling better was the most commonly reported nonadherence behavior (74%); those reporting "intentional" nonadherence when feeling better were more likely to report not using analgesics in the index week (100% vs. 67.7%; p = .029) and agree that pain medication can keep you from knowing what is going on in your body (p = .029) and were less likely to need stronger pain medication (33.3% vs. 81.5%; p = .003). "Unintentional" nonadherence, i.e., forgetfulness/carelessness, though associated with many analgesic beliefs, was not associated with measures of analgesic use in the index period. These preliminary data indicate that different heuristics underlie intentional versus unintentional nonadherence to analgesia and that intentional and unintentional nonadherence behaviors may have different implications for pain treatment outcomes.

  5. Pilot Study to Assess Safety and Clinical Outcomes of Irreversible Electroporation for Partial Gland Ablation in Men with Prostate Cancer

    PubMed Central

    Murray, Katie S.; Ehdaie, Behfar; Musser, John; Mashni, Joseph; Srimathveeravalli, Govindarajan; Durack, Jeremy C.; Solomon, Stephen B.; Coleman, Jonathan A.

    2016-01-01

    Purpose Partial prostate gland ablation is a strategy to manage localized prostate cancer. Irreversible electroporation can ablate localized soft tissues. We sought to describe 30- and 90-day complications and intermediate-term functional outcomes in men undergoing prostate gland ablation using irreversible electroporation. Materials and Methods We reviewed the charts of 25 patients with prostate cancer who underwent prostate gland ablation using irreversible electroporation as a primary procedure and who were followed for at least 6 months. Results Median follow-up was 10.9 months. Grade 3 complications occurred in 2 patients including epididymitis (1) and urinary tract infection (1). Fourteen patients experienced grade ≤ 2 complications, mainly transient urinary symptoms, hematuria, and urinary tract infections. Of 25 patients, 4 (16%) had cancer in the zone of ablation on routine follow-up biopsy at 6 months. Of those with normal urinary function at baseline, 88% and 94% reported normal urinary function at 6 and 12 months after prostate gland ablation, respectively. By 12 months, only 1 patient with normal erectile function at baseline reported new difficulty with potency and only 2 patients (8%) required a pad for urinary incontinence. Conclusions Prostate gland ablation with irreversible electroporation is feasible and safe in selected men with localized prostate cancer. Intermediate-term urinary and erectile function outcomes appear reasonable. Irreversible electroporation is effective in ablation of tumor-bearing prostate tissue, as a majority of men had no evidence of residual cancer on biopsy 6 months after prostate gland ablation. PMID:27113966

  6. A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol.

    PubMed

    Mahendran, Rathi; Tan, Joyce Yi Siang; Griva, Konstadina; Lim, Haikel Asyraf; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok

    2015-11-19

    Despite the rising trend of cancer prevalence and increase in family caregiving, little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver samples, particularly support groups, given the benefits that have been shown in studies on Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group psychotherapy for Singaporean family caregivers of patients receiving outpatient care. Facilitated by a clinical psychologist, this intervention is primarily based on the brief integrative psychological therapy with a supportive-expressive intent. Participants will be recruited while they are accompanying their care recipients for outpatient consultations. Since this is a pilot study, a sample size of 120 participants is targeted on the basis of sample sizes of previous studies. The study adopts a quasi-experimental design, as participants are assigned the intervention or control arms based on their availability to attend the intervention. A mixed methods approach is used to evaluate the outcomes of the intervention. A self-administered battery of tests is completed at four time points: baseline, postintervention and follow-up at 1-month and 2-month postinterventions; semi-structured interviews are conducted at baseline and post-intervention. Primary outcomes are quality of life and anxious and depressive symptoms; secondary outcomes are stress and basic psychological needs. Analysis using analysis of covariance would be conducted to determine the effectiveness of the intervention. This study protocol has ethics approval from the National Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every participant. Results will be disseminated through journals and conferences, and will be particularly relevant for clinicians intending to implement similar support groups to address the psychosocial concerns of caregivers, as well as for researchers

  7. Doxorubicin-Loaded 70-150 μm Microspheres for Liver-Dominant Metastatic Breast Cancer: Results and Outcomes of a Pilot Study.

    PubMed

    Lin, Yen-Ting; Médioni, Jacques; Amouyal, Grégory; Déan, Carole; Sapoval, Marc; Pellerin, Olivier

    2017-01-01

    Patients with breast cancer liver metastasis have a poor prognosis. Local therapy for liver metastasis increases survival. The purpose of this pilot prospective study was to evaluate the efficacy and safety of doxorubicin drug-eluting beads chemoembolization for liver-dominant breast cancer metastasis (LdBM) refractory to chemotherapy. All patients with LdBM refractory to of two or more lines of systemic chemotherapy were screened. Two chemoembolizations at 1-month intervals were scheduled for each patient. Tumor responses were evaluated by MRI every 3 months until progression or death. Adverse events were recorded according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.02) 1 month after each chemoembolization. All patients were free from systemic treatment until progression. Patients with hormone-positive receptors and/or HER-positive disease status continued their targeted therapy. Out of 23 patients enrolled (mean age: 57.5 ± 11.5 years), 17 completed two chemoembolizations and six underwent only one because of severe adverse events. At 3-month follow-up, the disease control rate was 83 %. The median progression-free survival from the first chemoembolization was 8 months, and the median overall survival was 17 months. Nineteen patients remained free from any systemic chemotherapy for a mean of 209 ± 92 days until progression. Eight grade 3 (asthenia n = 3, anemia n = 2, thrombocythemia n = 2, liver toxicity n = 1) (Rev 1 Comment 1) occurred after the first procedure. No patient died directly due to the procedure. While chemoembolization with doxorubicin eluding beads for refractory LdBM leads to an 83 % disease control rate, it also causes severe side effects that need to be adequately managed.

  8. Modulation of Breast Cancer Risk Biomarkers by High Dose Omega-3 Fatty Acids: Phase II Pilot Study in Pre-menopausal Women

    PubMed Central

    Fabian, Carol J; Kimler, Bruce F.; Phillips, Teresa A.; Box, Jessica A.; Kreutzjans, Amy L.; Carlson, Susan E.; Hidaka, Brandon H.; Metheny, Trina; Zalles, Carola M.; Mills, Gordon B.; Powers, Kandy R.; Sullivan, Debra K.; Petroff, Brian K.; Hensing, Whitney L.; Fridley, Brooke L.; Hursting, Stephen D

    2015-01-01

    Higher intakes of the omega-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to the omega-6 arachidonic acid (AA) have been variably associated with reduced risk of premenopausal breast cancer. The purpose of this pilot trial was to assess feasibility and explore effects of high dose EPA and DHA on blood and benign breast tissue risk biomarkers prior to design of a placebo controlled Phase IIB trial. Premenopausal women with evidence of hyperplasia +/- atypia by baseline random periareolar fine needle aspiration (RPFNA) were given 1860 mg of EPA + 1500 mg of DHA ethyl esters daily for 6 months. Blood and benign breast tissue were sampled during the same menstrual cycle phase pre-study and a median of 3 weeks after last dose. Additional blood was obtained within 24 hours of last dose. Feasibility which was pre-defined as 50% uptake, 85% retention and 70% compliance, was demonstrated with 46% uptake, 94% completion, and 85% compliance. Cytologic atypia decreased from 77 to 38% (p=0.002), and Ki-67 from a median of 2.1 to 1.0 % (p=0.021) with an increase in the ratio of EPA + DHA to AA in erythrocyte phospholipids but no change in blood hormones, adipokines, or cytokines. Exploratory breast proteomics assessment showed decreases in several proteins involved in hormone and cytokine signaling with mixed effects on those in the AKT/mTOR pathways. Further investigation of EPA plus DHA for breast cancer prevention in a placebo controlled trial in premenopausal women is warranted. PMID:26276744

  9. Exeresis and Brachytherapy as Salvage Treatment for Local Recurrence After Conservative Treatment for Breast Cancer: Results of a Ten-Year Pilot Study

    SciTech Connect

    Guix, Benjamin; Lejarcegui, Jose Antonio; Tello, Jose Ignacio; Zanon, Gabriel; Henriquez, Ivan; Finestres, Fernando; Martinez, Antonio; Fernandez-Ibiza, Jaume; Quinzanos, Luis; Palombo, Pau; Encinas, Xavier; Guix, Ines

    2010-11-01

    Purpose: To analyze the long-term results of a pilot study assessing excision and brachytherapy as salvage treatment for local recurrence after conservative treatment of breast cancer. Methods and Materials: Between December 1990 and March 2001, 36 patients with breast-only recurrence less than 3 cm in diameter after conservative treatment for Stage I or II breast carcinoma were treated with local excision followed by high-dose rate brachytherapy implants (30 Gy in 12 fractions over a period of 5 days). No patient was lost to follow-up. Special attention was paid to local, regional, or distant recurrences; survival; cosmesis; and early and late side effects. Results: All patients completed treatment. During follow-up (range, 1-13 years), 8 patients presented metastases (2 regional and 6 distant) as their first site of failure, 1 had a differed local recurrence, and 1 died of the disease. Actuarial results at 10 years were as follows: local control, 89.4%; disease-free survival, 64.4%; and survival, 96.7%. Cosmetic results were satisfactory in 90.4%. No patient had Grade 3 or 4 early or late complications. Of the 11 patients followed up for at least 10 years, all but 1 still had their breast in place at the 10-year stage. Conclusions: High-dose rate brachytherapy is a safe, effective treatment for small-size, low-risk local recurrence after local excision in conservatively treated patients. The dose of 30 Gy of high-dose rate brachytherapy (12 fractions over a period of 5 days twice daily) was well tolerated. The excellent results support the use of breast preservation as salvage treatment in selected patients with local recurrence after conservative treatment for breast cancer.

  10. Radioembolization with 90Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: final report of a prospective pilot study

    PubMed Central

    Kerlan, Robert K.; Hawkins, Randall A.; Pampaloni, Miguel; Taylor, Andrew G.; Kohi, Maureen P.; Kolli, K. Pallav; Atreya, Chloe E.; Bergsland, Emily K.; Kelley, R. Kate; Ko, Andrew H.; Korn, W. Michael; Van Loon, Katherine; McWhirter, Ryan M.; Luan, Jennifer; Johanson, Curt; Venook, Alan P.

    2016-01-01

    Background This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using 90Y glass microspheres. Methods Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of 90Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for up to 5.5 years after radioembolization. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Time to maximum response, response duration, progression-free survival (PFS) (hepatic and extrahepatic), and overall survival (OS) were measured. Results Median target dose and activity were 109.4 Gy and 2.6 GBq per treatment session, respectively. Majority of clinical AE were grade 1 or 2 in severity. Patients with colorectal cancer had hepatic objective response rate (ORR) of 25% and a hepatic disease control rate (DCR) of 80%. Median PFS and OS were 1.0 and 4.4 months, respectively. Patients with neuroendocrine tumors (NET) had hepatic ORR and DCR of 73% and 100%, respectively. Median PFS was 8.9 months for this cohort. DCR and median PFS and OS for patients with cholangiocarcinoma were 86%, 1.1 months, and 6.7 months, respectively. Conclusions 90Y glass microspheres device has a favorable safety profile, and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort. PMID:28078110

  11. A Pilot Study Using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) as a Clinical Care Tool to Identify Lower Extremity Lymphedema in Gynecologic Cancer Survivors

    PubMed Central

    Carter, Jeanne; Raviv, Leigh; Appollo, Kathleen; Baser, Raymond E.; Iasonos, Alexia; Barakat, Richard R.

    2016-01-01

    Objective To determine the feasibility and efficacy of using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) as a symptom scale for lymphedema of the lower extremity (LLE). Methods Twenty-eight gynecologic cancer survivors with documented LLE and 30 without a history or presence of lymphedema completed the GCLQ and provided feedback about their satisfaction with and feasibility of using the GCLQ at their oncology follow-ups. The study survey took approximately 5–10 minutes to complete, and it was easily understood by the majority of the sample. Results Participants had a mean age of 59.6 years (range, 28–80 years). Twenty-eight women (48%) had LLE and 30 (52%) had no history or presence of LLE (confirmed by limb volume [LV] measurements at assessment). Type of cancer history included: endometrial, 38 (66%); cervical, 13 (22%); and vulvar, 7 (12%). GCLQ scores differed significantly by lymphedema diagnosis; LLE patients had higher scores (P<0.01). The large area under the curve (AUC) of 0.95 (95% CI: 0.90–1.000) suggests that the GCLQ can distinguish between patients with and without LLE. Although all 28 (100%) of the LLE patients were aware of their LLE diagnosis, only 23 (82%) underwent treatment. The GCLQ was easily understood by most (55/58, 95%); and overall, patients showed a high willingness (56/58, 96%) to complete the questionnaire at future appointments. Twenty-five (88%) of the LLE patients found the GCLQ to be helpful in identifying symptoms of lymphedema. Conclusions The GCLQ effectively distinguished between gynecologic cancer survivors with and those without LLE, with good sensitivity and specificity. The patients, particularly those with LLE, showed high confidence in the GCLQ’s ability to detect LLE symptoms. PMID:20163847

  12. Classroom acoustics: Three pilot studies

    NASA Astrophysics Data System (ADS)

    Smaldino, Joseph J.

    2005-04-01

    This paper summarizes three related pilot projects designed to focus on the possible effects of classroom acoustics on fine auditory discrimination as it relates to language acquisition, especially English as a second language. The first study investigated the influence of improving the signal-to-noise ratio on the differentiation of English phonemes. The results showed better differentiation with better signal-to-noise ratio. The second studied speech perception in noise by young adults for whom English was a second language. The outcome indicated that the second language learners required a better signal-to-noise ratio to perform equally to the native language participants. The last study surveyed the acoustic conditions of preschool and day care classrooms, wherein first and second language learning occurs. The survey suggested an unfavorable acoustic environment for language learning.

  13. Use of indocyanine green and the HyperEye system for detecting sentinel lymph nodes in breast cancer within a population of European patients: a pilot study.

    PubMed

    Coufal, Oldřich; Fait, Vuk

    2016-12-01

    Certain studies suggest that using indocyanine green (ICG) could be comparable with using radioisotopes (RI) in detecting sentinel lymph nodes (SLNs) in breast cancer. A number of these studies were performed in Asia. The objective of our pilot study was to evaluate within a European population of breast cancer patients the detection rate of SLNs using ICG and the HyperEye system and the concordance in SLNs detected using this method and the standard method involving RI and a gamma probe. Ten female patients with early-stage breast cancer (Czech Republic) indicated for partial mastectomy and SLN biopsy were subjected to standard application of RI. Before surgery, ICG was administered periareolarly in the amount of 1 ml of 0.5% solution. Sentinel lymph nodes were first detected perioperatively exclusively using ICG fluorescence and the HyperEye device (Mizuho, Japan). Only after removal of all SLNs found in this way was the standard hand-held gamma probe used to detect RI, and any potential additional SLNs not found with ICG were then extirpated. In all 10 cases, at least one SLN was successfully detected using ICG. Nevertheless, in five patients, 1-4 additional SLNs were found using the gamma probe. Complete concordance in detecting SLNs therefore occurred in only one half of the cases. Metastases in SLNs were found in a total of two cases. Had we used only ICG for detection, one of these two cases would have been incorrectly evaluated as N0 (ICG false negativity). The study did not confirm the hypothesis that the use of ICG with the HyperEye system can currently be considered a method fully comparable with using RI and a gamma probe in a population of European patients. Although the detection rate is high, a significantly lower number of SLNs were detected using ICG than using RI (p = 0.03). Thus, there would be a higher probability for false negatives to occur in using SLN biopsy. This is caused mainly by the limited permeability of tissues to fluorescent

  14. Frequencies of Private Mentions and Sharing of Mammography and Breast Cancer Terms on Facebook: A Pilot Study

    PubMed Central

    Chetlen, Alison; Segel, Joel; Schetter, Susann

    2017-01-01

    Background The most popular social networking site in the United States is Facebook, an online forum where circles of friends create, share, and interact with each other’s content in a nonpublic way. Objective Our objectives were to understand (1) the most commonly used terms and phrases relating to breast cancer screening, (2) the most commonly shared website links that other women interacted with, and (3) the most commonly shared website links, by age groups. Methods We used a novel proprietary tool from Facebook to analyze all of the more than 1.7 million unique interactions (comments on stories, reshares, and emoji reactions) and stories associated with breast cancer screening keywords that were generated by more than 1.1 million unique female Facebook users over the 1 month between November 15 and December 15, 2016. We report frequency distributions of the most popular shared Web content by age group and keywords. Results On average, each of 59,000 unique stories during the month was reshared 1.5 times, commented on nearly 8 times, and reacted to more than 20 times by other users. Posted stories were most often authored by women aged 45-54 years. Users shared, reshared, commented on, and reacted to website links predominantly to e-commerce sites (12,200/1.7 million, 36% of all the most popular links), celebrity news (n=8800, 26%), and major advocacy organizations (n=4900, 15%; almost all accounted for by the American Cancer Society breast cancer site). Conclusions On Facebook, women shared and reacted to links to commercial and informative websites regarding breast cancer and screening. This information could inform patient outreach regarding breast cancer screening, indirectly through better understanding of key issues, and directly through understanding avenues for paid messaging to women authoring and reacting to content in this space. PMID:28600279

  15. Frequencies of Private Mentions and Sharing of Mammography and Breast Cancer Terms on Facebook: A Pilot Study.

    PubMed

    Huesch, Marco; Chetlen, Alison; Segel, Joel; Schetter, Susann

    2017-06-09

    The most popular social networking site in the United States is Facebook, an online forum where circles of friends create, share, and interact with each other's content in a nonpublic way. Our objectives were to understand (1) the most commonly used terms and phrases relating to breast cancer screening, (2) the most commonly shared website links that other women interacted with, and (3) the most commonly shared website links, by age groups. We used a novel proprietary tool from Facebook to analyze all of the more than 1.7 million unique interactions (comments on stories, reshares, and emoji reactions) and stories associated with breast cancer screening keywords that were generated by more than 1.1 million unique female Facebook users over the 1 month between November 15 and December 15, 2016. We report frequency distributions of the most popular shared Web content by age group and keywords. On average, each of 59,000 unique stories during the month was reshared 1.5 times, commented on nearly 8 times, and reacted to more than 20 times by other users. Posted stories were most often authored by women aged 45-54 years. Users shared, reshared, commented on, and reacted to website links predominantly to e-commerce sites (12,200/1.7 million, 36% of all the most popular links), celebrity news (n=8800, 26%), and major advocacy organizations (n=4900, 15%; almost all accounted for by the American Cancer Society breast cancer site). On Facebook, women shared and reacted to links to commercial and informative websites regarding breast cancer and screening. This information could inform patient outreach regarding breast cancer screening, indirectly through better understanding of key issues, and directly through understanding avenues for paid messaging to women authoring and reacting to content in this space.

  16. Periodontal Health in Women with Early Stage Postmenopausal Breast Cancer Newly on Aromatase Inhibitors: A Pilot Study

    PubMed Central

    Taichman, LS; Inglehart, MR; Giannobile, W; Braun, T; Kolenic, G; Van Poznak, C

    2015-01-01

    Background Aromatase inhibitor (AI) use results in low estrogen levels which in turn affect bone mineral density (BMD). Periodontitis, alveolar bone loss, and tooth loss are associated with low BMD. The goal of this study was to assess the prevalence of periodontitis, perceived oral health, and evaluate salivary biomarkers in postmenopausal women who are early stage (I-IIIA) breast cancer (BCa) survivors and receive adjuvant AI therapy. Methods Participants included 58 postmenopausal women; 29 with BCa on AIs and 29 controls without BCa diagnoses. Baseline periodontal status was assessed with: (1) periodontal pocket depth (PD); (2) bleeding on probing (BOP); and (3) attachment loss (AL). Demographic and dental utilization information was gathered by questionnaire. Linear regression modeling was used to analyze the outcomes. Results No differences in mean PD or the number of teeth were found. The AI group had significantly more sites with BOP (27.8 vs. 16.7; p = 0.02), higher worst-site AL (5.2 mm vs. 4.0 mm; p < 0.01) and more sites with dental calculus than did controls (18.2 vs. 6.4; p < 0.001). Linear regression adjusted for income, tobacco use, and dental insurance, and previous radiation and chemotherapy exposure demonstrated AI use increased CAL over 2 mm (95% CI: 0.46 -3.92). Median salivary osteocalcin and Tumor Necrosis Factor levels were significantly higher in the BCa group than the control group. Conclusions This first investigation of the periodontal status of women initiating adjuvant AI therapy identifies this population as having an increased risk for periodontitis (NCT1272570). PMID:25672657

  17. Impact of income and education on drug purchasing decisions in Hong Kong Chinese cancer patients: a pilot study.

    PubMed

    Chan, W M; Mak, J; Epstein, R J

    2011-01-01

    The affordability of diagnostic, preventive and therapeutic interventions is a global concern, particularly in the developing world. To clarify the educational and financial factors that influence purchasing decisions, we conducted a survey of Hong Kong cancer patients across a broad social spectrum. A questionnaire was designed to assess the effect of costs on purchasing decisions relating to six drug-related variables: efficacy, tolerability, convenience, safety, peer pressure, and uncertainty. Validation of the original 31-part survey resulted in a final set of 22 core questions that was administered to 51 consecutive oncology patients who were characterized in terms of varying household income and educational level. Most respondents (87.6%) were Hong Kong-born or mainland Chinese. There was a strong correlation between household income and education. Demand for drug tolerability and safety was high and cost-inelastic across all educational and income groups. An unexpected finding was that patients from low-income/education households were keen to purchase costly medications (whether Western, or Chinese herbs) of reputed high efficacy, whereas patients from middle-income/-education backgrounds were more negatively influenced by considerations of cost. Only the most affluent and well-educated patients valued overall survival above disease-free survival when making drug purchasing decisions; this cohort was also the least influenced by peer pressure, and the most willing to pay extra for drugs offering more convenience alone. Low-income/education Asian patients had paradoxically high expectations of costly drug interventions. Although larger studies addressing this issue are needed to confirm these conclusions, public education initiatives aimed at protecting low-income/education patients from exploitation or disappointment may be desirable.

  18. The impact of audiovisual biofeedback on 4D functional and anatomic imaging: Results of a lung cancer pilot study.

    PubMed

    Yang, Jaewon; Yamamoto, Tokihiro; Pollock, Sean; Berger, Jonathan; Diehn, Maximilian; Graves, Edward E; Loo, Billy W; Keall, Paul J

    2016-08-01

    The impact of audiovisual (AV) biofeedback on four dimensional (4D) positron emission tomography (PET) and 4D computed tomography (CT) image quality was investigated in a prospective clinical trial (NCT01172041). 4D-PET and 4D-CT images of ten lung cancer patients were acquired with AV biofeedback (AV) and free breathing (FB). The 4D-PET images were analyzed for motion artifacts by comparing 4D to 3D PET for gross tumor volumes (GTVPET) and maximum standardized uptake values (SUVmax). The 4D-CT images were analyzed for artifacts by comparing normalized cross correlation-based scores (NCCS) and quantifying a visual assessment score (VAS). A Wilcoxon signed-ranks test was used for statistical testing. The impact of AV biofeedback varied widely. Overall, the 3D to 4D decrease of GTVPET was 1.2±1.3cm(3) with AV and 0.6±1.8cm(3) for FB. The 4D-PET increase of SUVmax was 1.3±0.9 with AV and 1.3±0.8 for FB. The 4D-CT NCCS were 0.65±0.27 with AV and 0.60±0.32 for FB (p=0.08). The 4D-CT VAS was 0.0±2.7. This study demonstrated a high patient dependence on the use of AV biofeedback to reduce motion artifacts in 4D imaging. None of the hypotheses tested were statistically significant. Future development of AV biofeedback will focus on optimizing the human-computer interface and including patient training sessions for improved comprehension and compliance. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  19. Adolescent Project Pilot for an Outcome Study.

    ERIC Educational Resources Information Center

    Louden, Jenifer H.; Kamara, Sheku G.

    This report describes a 7-week pilot study conducted to estimate probable participation rates for a planned substance abuse treatment outcomes study. The pilot program tested whether acceptable response rates might be obtained by contacting clients whose records had been examined by an earlier study (retrospective) or by contacting current clients…

  20. A Hybrid Approach Using Case-Based Reasoning and Rule-Based Reasoning to Support Cancer Diagnosis: A Pilot Study.

    PubMed

    Saraiva, Renata M; Bezerra, João; Perkusich, Mirko; Almeida, Hyggo; Siebra, Clauirton

    2015-01-01

    Recently there has been an increasing interest in applying information technology to support the diagnosis of diseases such as cancer. In this paper, we present a hybrid approach using case-based reasoning (CBR) and rule-based reasoning (RBR) to support cancer diagnosis. We used symptoms, signs, and personal information from patients as inputs to our model. To form specialized diagnoses, we used rules to define the input factors' importance according to the patient's characteristics. The model's output presents the probability of the patient having a type of cancer. To carry out this research, we had the approval of the ethics committee at Napoleão Laureano Hospital, in João Pessoa, Brazil. To define our model's cases, we collected real patient data at Napoleão Laureano Hospital. To define our model's rules and weights, we researched specialized literature and interviewed health professional. To validate our model, we used K-fold cross validation with the data collected at Napoleão Laureano Hospital. The results showed that our approach is an effective CBR system to diagnose cancer.

  1. Pilot randomised study of early intervention based on tumour markers in the follow-up of patients with primary breast cancer.

    PubMed

    Mathew, J; Prinsloo, P; Agrawal, A; Gutteridge, E; Marenah, C; Robertson, J F R; Cheung, K L

    2014-10-01

    This pilot study aimed to test the possibility of therapeutic benefit imparted by early intervention based on sequential tumour marker (TM) measurements during follow-up of primary breast cancer (PBC) patients. Patients with oestrogen receptor positive PBC with no clinical and/or radiological evidence of metastases were recruited and followed-up 3-monthly with clinical assessment and TM (CA15.3 and CEA) measurements. The clinical team was blinded to the TM results. Asymptomatic patients who developed raised TMs (based on pre-defined cut-offs) were randomised to either 'treatment change' (either start or change of adjuvant endocrine agent to another agent) or 'no change' (control). Patients who developed symptomatic metastases came off the study. The primary and secondary endpoints were intervals from randomisation to symptomatic metastases and to last follow-up/death respectively. Eighty-five patients (median age = 54 years (30-72)) were recruited with a median follow-up of 81 months (1-124). Sixteen patients were randomised as described. There was no significant difference (treatment change versus no change) with regards to interval from randomisation to symptomatic metastases - 23 (2-62) and 22 (1-63) months respectively (p = 0.9), as well as interval from randomisation to last follow-up/death - 36 (7-63) and 37 (10-63) months respectively (p = 0.9). Despite long follow-up (up to 10+ years), this small study has thus far shown no significant difference in outcome. However, we have confirmed the feasibility of this study design but a larger study will be required to show if there is a benefit to this approach. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Association between the peroxisome proliferator-activated receptor gamma Pro12Ala variant and haplotype and pancreatic cancer in a high-risk cohort of smokers: a pilot study.

    PubMed

    Fesinmeyer, Megan Dann; Stanford, Janet L; Brentnall, Teresa A; Mandelson, Margaret T; Farin, Federico M; Srinouanprachanh, Sengkeo; Afsharinejad, Zahra; Goodman, Gary E; Barnett, Matt J; Austin, Melissa A

    2009-08-01

    The Pro12Ala variant in the peroxisome proliferator-activated receptor gamma (PPARG) gene has been associated with diabetes and several cancers. This pilot study tested for the association between Pro12Ala and pancreatic cancer risk in a high-risk sample of smokers. A nested case-control study was conducted in 83 incident cases of pancreatic cancer and 166 matched controls originally recruited into a cohort chemoprevention study of lung cancer. Associations between Pro12Ala and pancreatic cancer risk were measured using conditional logistic regression. Carriers of the G allele (Ala) of the Pro12Ala variant had a borderline increased relative risk of pancreatic cancer compared with homozygous carriers of the C allele (Pro), with an odds ratio of 1.79 (95% confidence interval [CI], 0.96-3.33; P=0.06). Among subjects randomized to high-dose vitamin A, the odds ratio was 2.80 (95% CI, 1.16-6.74; P=0.02) versus 1.20 (95% CI, 0.45-3.23; P=0.71) in the placebo group. A haplotype including Pro12Ala was also significantly associated with pancreatic cancer risk in all subjects and in subjects randomized to vitamin A. This analysis presents the first evidence that PPARG may be associated with pancreatic cancer risk, and this candidate gene should be investigated in future, larger studies.

  3. Effect of one-month treatment with vaginal promestriene on serum estrone sulfate levels in cancer patients: a pilot study.

    PubMed

    Del Pup, L; Postruznik, D; Corona, G

    2012-05-01

    Vaginal promestriene was tested in gynecological cancer patients who suffered from severe vaginal dryness and dyspareunia. This form of estrogen has a low level of vaginal absorption and proved to be effective for vaginal atrophy. 17 patients were treated with a 10mg soft vaginal suppository daily for one month. Plasma levels of estrone sulfate (E1S), used as the marker of overall estrogenicity, were measured by liquid chromatography in combination with mass spectrometry. Mean E1S levels changed from 533 (22-2920) to 374 (81-856) pg/ml (p=0.39). In highly symptomatic gynecological cancer patients the level of circulating estrone sulfate was not significantly affected by vaginal promestriene treatment overall, but a wide range of levels was noted pre and post treatment in individual patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  4. Responses to online GSTM1 genetic test results among smokers related to patients with lung cancer: a pilot study.

    PubMed

    Sanderson, Saskia C; O'Neill, Suzanne C; White, Della Brown; Bepler, Gerold; Bastian, Lori; Lipkus, Isaac M; McBride, Colleen M

    2009-07-01

    Providing smokers with personal genetic test results indicating increased lung cancer risk may increase uptake of effective smoking cessation services. Using the internet may increase reach and enable real-time assessment of how people process genetic risk information away from the clinic setting. We therefore explored smokers' responses to Web-delivered GSTM1 genetic test results indicating higher or lower lung cancer risk. Participants were smokers (n = 44) biologically related to patients with newly diagnosed lung cancer. Measures were assessed at baseline, before and immediately after receipt of online genetic test results, and at 6-month follow-up. Outcomes included accurate comprehension of results, regret about being tested, cessation-related cognitions (e.g., perceived response efficacy), and uptake of free smoking cessation services (nicotine replacement therapy, printed self-help materials, telephone counseling sessions). Twenty-two "relative smokers" received a GSTM1-missing (higher risk) and 22 a GSTM1-present (lower risk) result. All relative smokers with GSTM1-missing results and 55% of those with GSTM1-present results accurately interpreted their results. No relative smokers regretted having taken the test. Relative smokers receiving GSTM1-missing results reported lower confidence that quitting could reduce lung cancer risk (perceived response efficacy) than those receiving GSTM1-present results. There were no other significant between-group differences. Uptake of smoking cessation services was high (e.g., 91% nicotine replacement therapy uptake). Genetic test results may not influence uptake of free smoking cessation services because of ceiling effects. Further research is needed to determine the risks and benefits of Web-based disclosure of genetic test results.

  5. Intimacy-Enhancing Psychological Intervention for Men Diagnosed with Prostate Cancer and Their Partners: A Pilot Study

    PubMed Central

    Manne, S. L.; Kissane, D. W.; Nelson, C. J.; Mulhall, J. P.; Winkel, G.; Zaider, T.

    2011-01-01

    Introduction Few couple-focused interventions have been developed to improve distress and relationship outcomes among men diagnosed with localized prostate cancer and their partners. Aims We examined the effects of a five session Intimacy-Enhancing Therapy (IET) versus Usual Care (UC) on the psychological and relationship functioning of men diagnosed with localized prostate cancer and their partners. Pre-intervention levels of psychological and relationship functioning were evaluated as moderators of intervention effects. Methods Seventy one survivors and their partners completed a baseline survey and were subsequently randomly assigned to receive five sessions of IET or Usual Care (no treatment). Eight weeks after the baseline assessment, a follow-up survey was administered to survivor and partner. Main outcome measures Distress, well-being, relationship satisfaction, relationship intimacy, and communication were investigated as the main outcomes.. Results IET effects were largely moderated by pre-intervention psychosocial and relationship factors. Those survivors who had higher levels of cancer concerns at pre-treatment had significantly reduced concerns following IET. Similar moderating effects for pre-intervention levels were reported for the effects of IET on self-disclosure, perceived partner disclosure, and perceived partner responsiveness. Among partners beginning the intervention with higher cancer-specific distress, lower marital satisfaction, lower intimacy, and poorer communication, IET improved these outcomes. Conclusions IET had a marginally significant main effect upon survivor well-being but was effective among couples with fewer personal and relationship resources. Subsequent research is needed to replicate these findings with a larger sample and a longer follow-up. PMID:21210958

  6. Exhaled pentane as a possible marker for survival and lipid peroxidation during radiotherapy for lung cancer--a pilot study.

    PubMed

    Crohns, Marika; Saarelainen, Seppo; Laitinen, Jukka; Peltonen, Kimmo; Alho, Hannu; Kellokumpu-Lehtinen, Pirkko

    2009-10-01

    To examine lipid peroxidation during radiotherapy (RT), exhaled pentane samples were collected from 11 lung cancer patients before RT and 30 and 120 min after the start of RT on days 1, 4 and 5 and at 30 and 40 Grays, if possible. Exhaled pentane samples were collected once from 30 healthy controls. Serum thiobarbituric-acid-reactive substances (TBARS) and conjugated dienes (CD) were obtained from patients on each exhaled air collection day. Lung cancer patients had higher exhaled pentane levels than controls (1.73 ng/L vs 0.83 ng/L, p=0.017). Exhaled pentane levels tended to decrease during the first RT day (p=0.075) and levels of CD decreased during the first week of RT (p=0.014). Higher pre-treatment pentane levels predicted better survival (p=0.003). Elevated exhaled pentane levels before RT may be due to the lipid peroxidation burden associated with cancer. The decrease of lipid peroxidation markers during RT may be attributable to enhanced antioxidant defense mechanisms.

  7. Pilot study of effective methods for measuring and stretching for pectoral muscle tightness in breast cancer patients

    PubMed Central

    Lee, So Young; Sim, Mi Kyung; Do, Junghwa; Jeong, Soon Young; Jeon, Jae Yong

    2016-01-01

    [Purpose] To evaluate differences in pectoral muscle tightness according to arm abduction angle and to determine the best arm abduction angle for stretching of pectoral muscle tightness in breast cancer patients. [Subjects and Methods] Horizontal abduction differences of shoulders were measured bilaterally by arm abduction to 45°, 90°, and 135° to determine the best arm abduction angle for measuring pectoral muscle tightness. Thirty-two patients were divided into three pectoral muscle stretching groups (A: 45°, B: 90°, and C: 135°). We measured the shoulder range of motion, scores of the Disabilities of the Arm, Shoulder, and Hand, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the Breast Module, and pain levels (using a visual analog scale) before and after therapy. [Results] The differences in degree of horizontal abduction between shoulders were significantly larger for arm abduction to 90° and 135° than that to 45°. Groups B and C showed greater improvements in horizontal abduction limitations than group A. [Conclusion] Horizontal abduction differences between shoulders are prominent when arms are abducted to 90° and 135°. The appropriate arm abduction angle for measuring horizontal abduction and effective stretching of pectoral muscle tightness may be >90°. PMID:27942114

  8. A pilot study of gemcitabine in combination with oxaliplatin and vinorelbine in patients with metastatic bladder cancer.

    PubMed

    Pouessel, Damien; Huguet, Helena; Iborra, François; Rebillard, Xavier; Ayuso, Didier; Becht, Catherine; Culine, Stéphane

    2010-11-01

    To assess the safety and to obtain preliminary data on the efficacy of the three-drug combination chemotherapy with gemcitabine, oxaliplatin and vinorelbine in patients with metastatic bladder cancer. Patients with metastatic or locally unresectable advanced bladder cancer who had received either no or one previous systemic chemotherapy regimen were eligible. All patients received intravenous gemcitabine 700 mg/m(2) and vinorelbine 25 mg/m(2) on day 1, then intravenous oxaliplatin 85 mg/m(2) on day 2, every 14 days. Fifteen patients were enrolled. Twelve patients were unfit for cisplatin. A median of five cycles per patient were delivered. The most common toxicities were neutropenia, nausea and vomiting, mucositis and diarrhoea. Two complete responses and one partial response were observed for an overall response rate of 23%. Median progression-free survival was 5.7 months and overall survival was 8.6 months. Although active and tolerable, the described three-drug combination chemotherapy showed no obvious incremental increase in efficacy compared with two-drug regimens. Further clinical trials are not recommended.

  9. A pilot study on plasma levels of micro-RNAs involved in angiogenesis and vascular maturation in patients with breast cancer.

    PubMed

    Kontomanolis, Emmanuel; Mitrakas, Achilleas; Giatromanolaki, Alexandra; Kareli, Dimitra; Panteliadou, Marianthi; Pouliliou, Stamatia; Koukourakis, Michael I

    2017-02-01

    Micro-RNAs (miRNAs) have a complex role in carcinogenesis and tumour progression. Several miRNAs, such as miR-221, miR-27b and miR-132, have been implicated in the regulation of VEGF tumour angiogenic activity. In this pilot study, we assessed angiogenesis and DLL4+ vascular maturation index (VMI) in breast cancer tissues, in parallel with the plasma levels of the above-mentioned miRNAs. Significantly higher than control samples pre-operative levels were recorded in 10/11, 7/11 and 9/11 cases for the miR-221, miR-27b and miR-132, respectively. Seven days after surgery, a significant reduction of these miRNAs was noted in 6/11, 3/11 and 2/11 cases, respectively. High pre-operative levels of miR-27b were linked with node metastasis (p = 0.04). High pre-operative levels of miR-132 were linked with small tumours (p = 0.03) and her2 overexpression (p = 0.003). The DLL4+ VMI ranged from 26 to 69% (median 45%). Patients with poor DLL4+ VMI had significantly high pre-operative and post-operative levels of miR-221 (p = 0.01 and 0.02, respectively) and high post-operative levels of miR-132 (p = 0.02). It is concluded that angiogenesis-related miRs as detected in the plasma of patients may prove of a useful tool in the identification of patients with poor vascular maturation and high risk to develop metastasis. Whether such miRs may identify patients who would benefit from vascular normalization policies is a hypothesis that emerges from the current study.

  10. Pilot study of multiple-fraction daily radiotherapy alternating with chemotherapy in patients with stage IV non-oat cell lung cancer

    SciTech Connect

    Arcangeli, G.; Righini, R.; Nervi, C.; Guerra, A.; Tirindelli, D.; Hopkins, H.; Looney, W.

    1985-01-01

    From March 1982, 31 patients with stage IV non-oat cell lung cancer have been treated. Radiotherapy was given as three 2.00-Gy fractions on Days 1 and 2, 8 and 9, 22 and 23, and 29 and 30, for a total dose of 48 Gy over a 30-32-day treatment period. A three-drug combination of cyclophosphamide (400 mg/m2), doxorubicin (17 mg/m2), and methotrexate (15 mg/m2) was given on Days 3 and 24 and repeated thereafter every 21 days. Three of 31 evaluable patients (10%) achieved objective complete response and 18 of 31 (58%) achieved partial response (ie, regression of 50%-90%), while no change or disease progression was observed in ten of 31 (32%). The overall response rate in our study was 68%, which is a response much higher than other results in extensive disease. However, controlled trials will be necessary to definitively establish the superiority of this regimen to conventional trials. There was a significant shift of performance status towards higher values after treatment: 12 of the 27 patients classified in the 70-80 Karnofsky category before treatment moved to the higher category, 13 remained in the same status, and only two shifted to the worst category, indicating that the treatment had been effective in giving patients a better quality of life during their survival. The median survival was 35 weeks for the entire group of patients and 44 and 15 weeks for the responders and nonresponders, respectively. One of the primary findings of this pilot study was the ability to give one course of 12 Gy of radiation as multiple fractions per day during each of the first 2 weeks of treatment alternated with one course of chemotherapy, with most patients having very mild or no side effects.

  11. An Interprofessional Learning Workshop for Mammography and Sonography Students Focusing on Breast Cancer Care and Management Via Simulation: A Pilot Study.

    PubMed

    Giles, Eileen M; Parange, Nayana; Knight, Bronwyn

    2017-08-01

    The literature surrounding interprofessional education claims that students who learn with, from, and about one another in well-designed interprofessional programs will practice together collaboratively upon graduation, given the skills to do so. The objective of this study was to examine attitudes to interprofessional practice before and after an interprofessional learning (IPL) activity. A total of 35 postgraduate medical imaging students attended a week-long mammography workshop. The sessions provided a range of didactic sessions related to diagnosis and management of breast cancer. An IPL session was incorporated on completion of the workshop to consolidate learning. Props and authentic resources were used to increase the fidelity of the simulation. Participants completed pre- and post-workshop questionnaires comprising an interprofessional education and collaboration scale and a quiz to gauge knowledge of specific content related to professional roles. Responses to each statement in the scale and quiz score, pre or post workshop, were compared, whereas responses to open-ended questions in post-workshop survey were thematically analyzed. Seventeen paired surveys were received. There was a significant total improvement of 10.66% (P = .036). After simulation, there was a statistically significant improvement in participants' understanding (P < .05) that IPL offers holistic care to the patient and that teamwork is useful for reducing errors in patient care. Simulation helped participants develop more awareness of their role within the profession, improve their understanding of other professionals, and gain more realistic expectations of team members. This pilot study confirmed learning within an IPL simulation improved attitudes toward shared learning, teamwork, and communication. Simulation provides opportunities for learning in a safe environment, and technology can be used in diverse ways to provide authentic learning. Copyright © 2017 The Association

  12. My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer

    PubMed Central

    Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim

    2017-01-01

    Background The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. Objective The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. Methods We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Results Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months

  13. My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.

    PubMed

    Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim; Husain, Amna

    2017-07-18

    The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months of follow-up, respectively. A mean

  14. Pilot Implementation of Breast Cancer Early Detection Programs in Colombia

    PubMed Central

    Murillo, Raúl; Díaz, Sandra; Sánchez, Oswaldo; Perry, Fernando; Piñeros, Marion; Poveda, César; Salguero, Edgar; Osorio, Dimelza

    2008-01-01

    Summary Breast cancer is increasing in developing countries, and Colombia has a double burden from cervical and breast cancer. Suitable guidelines for breast cancer early detection are needed, and the Breast Health Global Initiative provides a favorable framework for breast cancer control in low resource nations. The Colombian National Cancer Institute developed evidence-based guidelines for breast cancer early detection in which coordinated early detection in symptomatic women and hospital-based screening in women aged 50–69 are recommended. A pilot project to evaluate programmatic approaches (opportunistic screening) was designed, and it is expected that organized hospital-based screening for breast cancer will represent a move towards population-based screening in the near future in accordance with country specific conditions. PMID:20824017

  15. Inhaled isotretinoin (13-cis retinoic acid) is an effective lung cancer chemopreventive agent in A/J mice at low doses: a pilot study.

    PubMed

    Dahl, A R; Grossi, I M; Houchens, D P; Scovell, L J; Placke, M E; Imondi, A R; Stoner, G D; De Luca, L M; Wang, D; Mulshine, J L

    2000-08-01

    In previously treated head-and-neck cancer patients, p.o. administered isotretinoin (13-cis retinoic acid) reduced the occurrence of second aerodigestive tumors, including lung tumors, but side effects made chronic therapy problematic. We reasoned that inhaled isotretinoin might provide sufficient drug to the target cells for efficacy while avoiding systemic toxicity, and we proceeded with the pilot study reported here. Male A/J mice were given single i.p. doses of urethane, a common experimental lung carcinogen, or benzo[a]pyrene (BaP) or 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), putative major carcinogens in tobacco smoke. The following day, exposures to isotretinoin aerosols for 45 min daily at 1.3, 20.7, or 481 microg/l were initiated. After 2 weeks, the high dose caused severe toxicity on the snout skin, necessitating a reduction of dose frequency to twice a week. As a precaution, the mid dose was reduced to three exposures per week. The weekly total deposited doses after the dose frequency reductions were calculated to be 0.24, 1.6, and 24.9 mg/kg for the low, mid, and high doses, of which 16% was estimated to be deposited in the lungs. The weekly deposited pulmonary drug doses were calculated to be 0.01, 0.07, and 1.1% of a previously reported ineffective oral dose in urethane-treated A/J mice. After 10-16 weeks, mice were sacrificed to count areas of pulmonary hyperplasia and adenomas. For all carcinogens, the mice exposed to the high isotretinoin dose showed reductions of tumor multiplicity ranging from 56 to 80% (P < 0.005). The mid dose was associated with reductions of tumor multiplicity by 67 and 88% (P < 0.005) in BaP- and NNK-treated mice, respectively, and was tolerated until approximately 12 weeks, when both these and the high-dose mice began losing weight. The low-dose mice had nonsignificant reductions of 30% (P < 0.13) and 16% (P < 0.30) for BaP- and NNK-treated mice, respectively without any evidence of side effects. For BaP- and

  16. A pilot study to evaluate the feasibility of using willingness to pay as a measure of value in cancer supportive care: an assessment of amifostine cytoprotection.

    PubMed

    Dranitsaris, G

    1997-11-01

    The most commonly used method for pharmacoeconomic studies has been the cost-effectiveness analysis (CEA), where the outcome is expressed as an incremental cost per unit of effectiveness (e.g. quality-adjusted life years). Although CEA is a valuable tool for identifying therapies that are more effective and less expensive, deficiencies develop when a given treatment is both more expensive and more effective. An alternative that has not been investigated in the oncology setting is the willingness-to-pay (WTP) method. In this pilot study, a WTP strategy was utilized to estimate the value that the Canadian tax-paying public puts on amifostine, a new cytoprotective agent that reduces the risk of chemotherapy-induced toxicity. The method of WTP was used within the framework of a classical cost-benefit analysis to estimate the net cost or benefit of prophylactic amifostine in patients with ovarian cancer who were receiving chemotherapy. This included direct costs for amifostine administration and hospital savings secondary to the reduced incidence of antineoplastic toxicity. A random sample of 50 Canadian tax-payers were interviewed to ascertain their maximum WTP for the new drug. The WTP survey instrument was simple to administer and easily understood by participants. Respondents stated that they would be willing to pay an average of $Can3,476 (95% confidence interval = $Can2,275 to $Can4,676) as an income tax increase to be paid over their lifetime for the value offered by the product. The benefit was then subtracted from the overall cost of amifostine ($Can3,826). This produced a net cost of $Can350 per patient (95% confidence interval = -$Can850 to $Can1,551), suggesting a situation of cost neutrality. WTP as a measure of value for oncology products is feasible and should be considered for future economic evaluations. The strategy is currently being used at this institution to determine the net societal cost or benefit of other cancer supportive care therapies, such

  17. Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: a pilot study.

    PubMed

    Rossi, Luigi; Tomao, Federica; Lo Russo, Giuseppe; Papa, Anselmo; Zoratto, Federica; Marzano, Raffaella; Basso, Enrico; Giordani, Erika; Verrico, Monica; Ricci, Fabio; Pasciuti, Giulia; Francini, Edoardo; Tomao, Silverio

    2013-01-01

    Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy. Twenty women were enrolled. All patients received epirubicin 100 mg/m(2) with 5-fluorouracil 500 mg/m(2) and cyclophosphamide 500 mg/m(2) on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS). The incidence of grade 3-4 neutropenia was 75% in patients who received pegfilgrastim, and 25% in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5% of pegfilgrastim patients versus 58.3% of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group. In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.

  18. A Pilot Study of Catheter-Based Ultrasound Hyperthermia with HDR Brachytherapy for Treatment of Locally Advanced Cancer of the Prostate and Cervix

    NASA Astrophysics Data System (ADS)

    Diederich, Chris J.; Wootton, Jeff; Prakash, Punit; Salgaonkar, Vasant; Juang, Titania; Scott, Serena; Chen, Xin; Cunha, Adam; Pouliot, Jean; Hsu, I. C.

    2011-09-01

    Interstitial and endocavity ultrasound devices have been developed specifically for applying hyperthermia within temporary HDR brachytherapy implants during radiation therapy. Catheter-based ultrasound applicators are capable of 3D spatial control of heating in both angle and length of the devices, with enhanced radial penetration of heating compared to other hyperthermia technologies. A pilot study of the combination of catheter based ultrasound with HDR brachytherapy for locally advanced prostate and cervical cancer has been initiated, and preliminary results of the performance and heating distributions are reported herein. The treatment delivery platform consists of a 32 channel RF amplifier and a 48 channel thermocouple monitoring system. Controlling software can monitor and regulate frequency and power to each transducer section as required during the procedure. Interstitial applicators consist of multiple transducer sections of 2-4 cm length×180 deg and 3-4 cm×360 deg. heating patterns to be inserted in specific placed 13g implant catheters. The endocavity device, designed to be inserted within a 6 mm OD plastic tandem catheter within the cervix, consists of 2-3 transducers x dual 180 or 360 deg sectors. 3D temperature based treatment planning and optimization is dovetailed to the HDR optimization based planning to best configure and position the applicators within the catheters, and to determine optimal base power levels to each transducer section. To date we have treated eight cervix implants and four prostate implants. 100% of treatments achieved a goal of >60 min duration, with therapeutic temperatures achieved in all cases. Thermal dosimetry within the hyperthermia target volume (HTV) and clinical target volume (CTV) are reported. Catheter-based ultrasound hyperthermia with HDR appears feasible with therapeutic temperature coverage of the target volume within the prostate or cervix while sparing surrounding more sensitive regions.

  19. Increased metabolic activity detected by FLIM in human breast cancer cells with desmoplastic reaction: a pilot study

    NASA Astrophysics Data System (ADS)

    Natal, Rodrigo de Andrade; Pelegati, Vitor B.; Bondarik, Caroline; Mendonça, Guilherme R.; Derchain, Sophie F.; Lima, Carmen P.; Cesar, Carlos L.; Sarian, Luís. O.; Vassallo, José

    2015-07-01

    Introduction: In breast cancer (BC), desmoplastic reaction, assembled primarily by fibroblasts, is associated with unfavorable prognosis, but the reason of this fact remains still unclear. In this context, nonlinear optics microscopy, including Fluorescence Lifetime Imaging Microscopy (FLIM), has provided advancement in cellular metabolism research. In this paper, our purpose is to differentiate BC cells metabolism with or without contact to desmoplastic reaction. Formalin fixed, paraffin embedded samples were used at different points of hematoxylin stained sections. Methodology: Sections from 14 patients with invasive ductal breast carcinoma were analyzed with FLIM methodology to NAD(P)H and FAD fluorescence lifetime on a Confocal Upright LSM780 NLO device (Carl Zeiss AG, Germany). Quantification of the fluorescence lifetime and fluorescence intensity was evaluated by SPC Image software (Becker &Hickl) and ImageJ (NIH), respectively. Optical redox ratio was calculated by dividing the FAD fluorescence intensity by NAD(P)H fluorescence intensity. Data value for FLIM measurements and fluorescence intensities were calculated using Wilcoxon test; p< 0.05 was considered significant. Results: BC cells in contact with desmoplastic reaction presented a significantly lower NAD(P)H and FAD fluorescence lifetime. Furthermore, optical redox ratio was also lower in these tumor cells. Conclusion: Our results suggest that contact of BC cells with desmoplastic reaction increase their metabolic activity, which might explain the adverse prognosis of cases associated with higher peritumoral desmoplastic reaction.

  20. Breast Cancer Risk Assessment Among Low-Income Women of Color in Primary Care: A Pilot Study

    PubMed Central

    Anderson, Emily E.; Tejeda, Silvia; Childers, Kimberly; Stolley, Melinda R.; Warnecke, Richard B.; Hoskins, Kent F.

    2015-01-01

    Purpose: The US Preventive Services Task Force recommends identifying candidates for breast cancer (BC) chemoprevention and referring them for genetic counseling as part of routine care. Little is known about the feasibility of implementing these recommendations or how low-income women of color might respond to individualized risk assessment (IRA) performed by primary care providers (PCPs). Methods: Women recruited from a federally qualified health center were given the option to discuss BC risk status with their PCP. Comprehensive IRA was performed using a software tool designed for the primary care environment combining three assessment instruments and providing risk-adapted recommendations for screening, prevention, and genetic referral. Logistic regression models assessed factors associated with wanting to learn and discuss BC risk with PCP. Results: Of 237 participants, only 12.7% (n = 30) did not want to discuss IRA results with their PCP. Factors associated with lower odds of wanting to learn results included having private insurance and reporting ever having had a mammogram. Factors associated with higher odds of wanting to learn results included older age (50 to 69 years) and increased BC worry. For all women wishing to learn results, IRA was successfully completed and delivered to the PCP immediately before the encounter for incorporation into the well-visit evaluation. Conclusion: Incorporation of US Preventive Services Task Force recommendations as part of routine primary care is feasible. Interest in IRA seems high among underserved women. This approach warrants further investigation as a strategy for addressing disparities in BC mortality. PMID:26036266

  1. Impact of fish oil and melatonin on cachexia in patients with advanced gastrointestinal cancer: a randomized pilot study.

    PubMed

    Persson, Christina; Glimelius, Bengt; Rönnelid, Johan; Nygren, Peter

    2005-02-01

    The effect of fish oil (FO), melatonin (MLT), or their combination and dietary advice on cachexia and biochemistry variables reflecting cachexia were investigated in patients with advanced gastrointestinal cancer. Twenty-four patients not amenable to standard anticancer treatment and with documented weight loss and/or decreased serum albumin were included. They were randomized to 30 mL/d of FO, which provided 4.9 g of eicosapentaenoic acid and 3.2 g of docosahexanoic acid, or 18 mg/d of MLT for 4 wk. During the next 4 wk, all patients had FO and MLT. Serum or plasma was analyzed for tumor necrosis factor-alpha, interleukin-1beta, soluble interleukin-2 receptor, interleukin-6, and interleukin-8 and the fatty acids eicosapentaenoic acid, docosahexanoic acid, arachidonic acid, and linoleic acid. Serum levels of eicosapentaenoic acid and docosahexanoic acid increased as expected with FO. No major changes in biochemical variables and cytokines were observed with any intervention. In the FO group, 5 of 13 patients (38%) showed weight stabilization or gain compared with 3 of 11 patients (27%) in the MLT group. After combining interventions, approximately 63% of patients showed such responses. FO, MLT, or their combination did not induce major biochemical changes indicative of a strong anticachectic effect. Nonetheless, the interventions used may have produced a weight-stabilizing effect.

  2. Could gut microbiota serve as prognostic biomarker associated with colorectal cancer patients' survival? A pilot study on relevant mechanism

    PubMed Central

    Wei, Zhiliang; Cao, Shougen; Liu, Shanglong; Yao, Zengwu; Sun, Teng; Li, Yi; Li, Jiante; Zhang, Dongfeng; Zhou, Yanbing

    2016-01-01

    Evidences have shown that dysbiosis could promote the progression of colorectal cancer (CRC). However, the association of dysbiosis and prognosis of CRC is barely investigated. Therefore, we used 16S rRNA gene sequencing approach to determine differences in microbiota among tumor tissues of different prognosis and found that Fusobacterium nucleatum and Bacteroides fragilis were more abundant in worse prognosis groups, while Faecalibacterium prausnitzii displayed higher abundance in survival group. To further explore the prognostic value of the found bacteria, Kaplan–Meier and Cox proportional regression analyses were used and the results exhibited that high abundance of F. nucleatum and B. fragilis were independent indicators of poor patient's survival. Besides, the expression of major inflammatory mediator were analyzed using PCR and western blot methods, and it turned out that high abundance of F. nucleatum was associated with increased expression of TNF-α, β-catenin and NF-κB, while COX-2, MMP-9 and NF-κB were positively related with high B. fragilis level, and high level of F. prausnitzii showed lower expression of β-catenin, MMP-9 and NF-κB. Moreover, immunohistochemical analysis indicated that KRAS and BRAF expression were prominent in F. nucleatum and B. fragilis high abundance group, while MLH1 showed lower expression. In conclusion, F. nucleatum, B. fragilis and F. prausnitzii can be identified as useful prognostic biomarkers for CRC, and dysbiosis might worsen the patients' prognosis by up-regulating gut inflammation level. PMID:27323816

  3. Parent-directed intervention for children with cancer-related neurobehavioral late effects: a randomized pilot study.

    PubMed

    Patel, Sunita K; Ross, Paula; Cuevas, Michelle; Turk, Anne; Kim, Heeyoung; Lo, Tracy T Y; Wong, Lennie F; Bhatia, Smita

    2014-10-01

    OBJECTIVE : To evaluate feasibility and preliminary efficacy of an intervention directed at parents of childhood cancer survivors (CCSs) with neurobehavioral late effects to improve targeted parenting skills, and thus to indirectly benefit the child's educational functioning.  METHODS : 44 CCSs and their parents were randomized. Intervention-arm parents participated in eight individual training sessions augmented by a 3-month telephone support period. Pre- and postparent measures and child performance on Wechsler Individual Achievement Test-II and School Motivation and Learning Strategies Inventory assessed intervention effects.  RESULTS : 90% of intervention parents completed the program with high adherence/perceived benefit. Between-group effect sizes ranged from d = 0.77 to d = 1.45 for parent knowledge, efficacy, frequency of pro-learning behaviors, and d = 0.21 to d = 0.76 for child academic scores. Parental time spent in intervention activities was associated with academic change.  CONCLUSIONS : A parent-directed intervention to indirectly promote academic functioning in CCSs appears feasible and effective in improving targeted parenting outcomes and for selected child academic outcomes.

  4. Validity and Reliability of Using a Self-Lavaging Device for Cytology and HPV Testing for Cervical Cancer Screening: Findings from a Pilot Study

    PubMed Central

    Jones, Heidi E.; Mansukhani, Mahesh M.; Tong, Guo-Xia; Westhoff, Carolyn L.

    2013-01-01

    Self-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008–2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1–3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV

  5. Identification of familial colorectal cancer and hereditary colorectal cancer syndromes through the Dutch population-screening program: results ofa pilot study.

    PubMed

    van Erp, Sanne J H; Leicher, Laura W; Hennink, Simone D; Ghorbanoghli, Zeinab; Breg, Simone A C; Morreau, Hans; Nielsen, Maartje; Hardwick, James C H; Roukema, Jan A; Langers, Alexandra M J; Cappel, Wouter H de Vos Tot Nederveen; Vasen, Hans F A

    2016-10-01

    In 2014, a population-screening program using immuno-faecal occult blood testing (I-FOBT) has started in the Netherlands. The aims of this study were to evaluate the proportion of individuals in the Dutch screening program with a positive I-FOBT that fulfill the criteria for familial colorectal cancer (FCC) and to evaluate the proportion of participants that needs genetic counseling or colonoscopic surveillance. This retrospective observational study was performed in two large hospitals. Individuals aged between 55 and 75 years with a positive I-FOBT that underwent colonoscopy were included. A detailed family history was obtained in all individuals. A total of 657 individuals with a positive I-FOBT test underwent colonoscopy. A total of 120 (18.3%) participants were found to have a positive family history for CRC, 20 (3.0%) fulfilled the FCC criteria, 4 (0.6%) the Bethesda guidelines and 1 (0.2%) participant the Amsterdam criteria. Multiple adenomas (>10) were found in 21 (3.2%) participants. No cases of serrated polyposis were identified. Based on these criteria and guidelines, a total of 35 (5.3%) required referral to the clinical geneticist and the relatives of 20 (3.0%) participants should be referred for surveillance colonoscopy. Obtaining a detailed family history at the time of intake of participants with a positive I-FOBT in the Dutch surveillance program increased the identification of participants with familial CRC.

  6. A Pilot Study of Predictive Markers of Chemotherapy-Related Amenorrhea Among Premenopausal Women with Early Stage Breast Cancer

    PubMed Central

    Anders, Carey; Marcom, P. Kelly; Peterson, Bercedis; Gu, Lin; Unruhe, Sue; Welch, Renee; Lyons, Peggy; Kimmick, Gretchen; Shaw, Heather; Snyder, Stacey; Antenos, Monica; Woodruff, Teresa; Blackwell, Kimberly

    2010-01-01

    Background Premenopausal women treated for early stage breast cancer (ESBC) are at risk for chemotherapy-related amenorrhea (CRA). Prospectively-validated, predictive markers of CRA are needed. Patients and Methods Premenopausal women with ESBC and planned chemotherapy (≥ 25% risk of amenorrhea) were evaluated. Follicle stimulating hormone (FSH), estradiol, Inhibin A and B, anti-Müllerian hormone (AMH), and quality of life (QOL) were prospectively evaluated pre-, post-, 6 months and 1 year post-chemotherapy and correlated with age and menstrual status. CRA was defined as absence of menses 1 year post-chemotherapy. Results Forty-four women were evaluated at the time of analysis. Median age at diagnosis and FSH 1 year post-chemotherapy were higher among women with CRA (44 yrs [33–51] vs. 40 yrs [31–43]; p = 0.03; 39.8 vs. 5.0 mLU/mL, p = 0.0058, respectively). Median estradiol 1 year post-chemotherapy was higher among women who resumed menses (108.3 vs. 41.3 pg/mL, p = 0.01). Pre-chemotherapy median Inhibin B and AMH were lower among women with CRA (33.2 vs. 108.8 pg/mL; p = 0.03; 0.16 vs. 1.09 ng/mL, p = 0.02, respectively). The risk of CRA was increased among women with lower pre-chemotherapy Inhibin B (RR = 1.67, p = 0.15) and AMH (RR = 1.83, p = 0.05). Amongst women whose pre-chemotherapy Inhibin B and AMH values were below the median, the incidence of CRA was 87.5%. Conclusions Results indicate that pre-chemotherapy Inhibin B and AMH are lower among women experiencing CRA and may be predictive of CRA among premenopausal women facing chemotherapy for ESBC. PMID:18317970

  7. Knowledge about cancer in West Bengal - a pilot survey.

    PubMed

    Ray, Kausik; Mandal, Syamsundar

    2004-01-01

    A pilot survey was conducted based on 900 respondents of the population of West Bengal to assess their level of awareness regarding cancer with the aim of estimating associations between response variables (knowledge about cancer) and predictor variables (age, sex, level of education). The data of the pilot survey revealed that 98% of the respondents had heard of the disease 'Cancer'. Unfortunately only 35% of the respondents were aware of the 7-danger signals (i.e. the primary symptoms of cancer) as defined by the World Health Organisation (WHO). None of the respondents knew all 7-primary symptoms of cancer and the majority (about 88%) knew only one or two (mainly tumour lumps and ulcers). Only 44.67% were aware of the major risk factors (like smoking and tobacco chewing). The percentage of the respondents believing that most cancers are curable in early stages was 58%. Some of the respondents (21%) expressed the vague idea that cancer is a infectious disease which is creating a problem of isolation from the family/society with some unfortunate cancer patients. Over 11% of the respondents suggested that a cancer diagnosis should be kept secret from neighbours due to some social stigma like problems with daughters' marriage. Only 8% had experienced any cancer awareness programme conducted by any organisation, only 37% had listened to any cancer awareness programme conducted by the All India Radio, only 36% had seen any cancer awareness programme conducted by Doordarsan/ private Television channels, only 34% had read cancer awareness articles in the newspapers/magazines and only 13% had seen posters/hoardings regarding cancer awareness. The results thus revealed a huge lack regarding cancer awareness in the region. Most of the respondents (68%) expressed a wish for starting cancer awareness programmes. From the Pilot Survey it has been found that the average Knowledge Index of the respondents is 58+ 1.7 irrespective of the socio-economic and personal status. On

  8. Is thyroid gland an organ at risk in breast cancer patients treated with locoregional radiotherapy? Results of a pilot study.

    PubMed

    Tunio, Mutahir Ali; Al Asiri, Mushabbab; Bayoumi, Yasser; Stanciu, Laura G; Al Johani, Naji; Al Saeed, Eyad Fawzi

    2015-01-01

    Aim was to evaluate the dose distribution within the thyroid gland its association with hypothyroidism in breast cancer (BC) patients receiving supraclavicular (SC) radiation therapy (RT). Consecutive 40 BC patients with baseline normal thyroid function tests (TFTs), were randomized into two groups: (a) Adjuvant chest wall/breast with SC-RT (20 patients) and (b) control group (adjuvant chest wall/breast RT only); 20 patients. The thyroid gland was contoured for each patient. Each patient's dose volume histogram (DVH), mean thyroid volume, the volume percentages of the thyroid absorbing respectively 5, 10, 20, 30, 40, and 50 Gy (V5, V10, V20, V30, V40, and V50), and Dmean (average dose in whole volume of thyroid) were then estimated. TFTs were performed at the time of the last follow-up and compared. Mean thyroid volume of cohort was 19.6 cm(3) (4.02-93.52) and Dmean of thyroid gland in SC-RT and control group was 25.8 Gy (16.4-52.2) and 5.6 Gy (0.7-12.8), respectively. Median values of V5, V10, V20, V30, V40, and V50 were 54%, 51%, 42.8%, 30.8%, 27.8%, and 7.64%, respectively, in SC-RT as compared to control group (V5;4.9%, V10;2.4%, V20;1.75%, V301%, V40;0%, and V50;0%, respectively) with P < 0.0001. At 52 months, a majority of patients (90%) had a normal thyroid function whereas four patients (10%) had hypothyroidism; 3/20 (15%) patients in SC-RT and 1/20 (5%) in control group with P < 0.001. Significant prognostic factors were; SC-RT (P = 0.001), V30 above 50% (P = 0.001), and smaller thyroid volume (P = 0.03). The risk of hypothyroidism in BC patients after SC-RT depends on the thyroid gland volume and V30 >50% and the risk can be minimized by thyroid gland shielding during RT.

  9. BIMOMASS GASIFICATION PILOT PLANT STUDY

    EPA Science Inventory

    The report gives results of a gasification pilot program using two biomass feedstocks: bagasse pellets and wood chips. he object of the program was to determine the properties of biomass product gas and its suitability as a fuel for gas-turbine-based power generation cycles. he f...

  10. BIMOMASS GASIFICATION PILOT PLANT STUDY

    EPA Science Inventory

    The report gives results of a gasification pilot program using two biomass feedstocks: bagasse pellets and wood chips. he object of the program was to determine the properties of biomass product gas and its suitability as a fuel for gas-turbine-based power generation cycles. he f...

  11. Phospholipid makeup of the breast adipose tissue is impacted by obesity and mammary cancer in the mouse: Results of a pilot study.

    PubMed

    Margolis, Michael; Perez, Osvaldo; Martinez, Mitchell; Santander, Ana M; Mendez, Armando J; Nadji, Mehrdad; Nayer, Ali; Bhattacharya, Sanjoy; Torroella-Kouri, Marta

    2015-01-01

    Obesity, an established risk factor for breast cancer (BC), is associated with systemic inflammation. The breast contains adipose tissue (bAT), yet whether it plays a role in BC progression in obese females is being intensively studied. There is scarce knowledge on the lipid composition of bAT in health and disease. The purpose of this pilot study was: 1) to determine whether obesity and BC are associated with inflammatory changes in bAT 2) to analyze for the first time the lipid profile of bAT in obese and lean mammary tumor-bearing and normal mice. Syngeneic E0771 mammary tumor cells were implanted into the mammary fat pad of lean and diet-induced obese C57BL/6 mice. BATs were analyzed four weeks after tumor cell inoculation by immunohistochemistry and mass spectrometry. Phospholipids were identified and subjected to ratiometric quantification using a TSQ Quantum Access Max triple quadrupole mass spectrometer utilizing precursor ion scan or neutral ion loss scan employing appropriate class specific lipid standards in a two step quantification process. Four main classes of phospholipids were analyzed: phosphatidylcholines phosphatidylserines, phosphatidylethanolamines and phosphatidylinositols. Our results showed that bAT in obese (normal and tumor-bearing) mice contained hypertrophic adipocytes compared with their corresponding samples in lean mice; higher numbers of macrophages and crown-like structures were observed in obese tumor bearers compared to obese normal mice. BAT from normal obese mice revealed higher concentrations of phosphatidylethanolamines. Furthermore, bAT from tumor-bearing mice expressed higher phosphatidylcholines than that from non-tumor bearing mice, suggesting the presence of the tumor is associated with phosphatidylcholines. Conversion of phosphatidylethanolamines to phosphatidylcholines will be investigated in E0771 cells. Additional studies are projected to investigate macrophage activation by these specific classes of phospholipids

  12. An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

    PubMed

    Brinton, John T; Ringham, Brandy M; Glueck, Deborah H

    2015-10-13

    For studies that compare the diagnostic accuracy of two screening tests, the sample size depends on the prevalence of disease in the study population, and on the variance of the outcome. Both parameters may be unknown during the design stage, which makes finding an accurate sample size difficult. To solve this problem, we propose adapting an internal pilot design. In this adapted design, researchers will accrue some percentage of the planned sample size, then estimate both the disease prevalence and the variances of the screening tests. The updated estimates of the disease prevalence and variance are used to conduct a more accurate power and sample size calculation. We demonstrate that in large samples, the adapted internal pilot design produces no Type I inflation. For small samples (N less than 50), we introduce a novel adjustment of the critical value to control the Type I error rate. We apply the method to two proposed prospective cancer screening studies: 1) a small oral cancer screening study in individuals with Fanconi anemia and 2) a large oral cancer screening trial. Conducting an internal pilot study without adjusting the critical value can cause Type I error rate inflation in small samples, but not in large samples. An internal pilot approach usually achieves goal power and, for most studies with sample size greater than 50, requires no Type I error correction. Further, we have provided a flexible and accurate approach to bound Type I error below a goal level for studies with small sample size.

  13. High-risk human papillomavirus in HIV-infected women undergoing cervical cancer screening in Lilongwe, Malawi: A pilot study

    PubMed Central

    Reddy, Deepa; Njala, Joseph; Stocker, Penny; Schooley, Alan; Flores, Martiniano; Tseng, Chi-Hong; Pfaff, Colin; Jansen, Perry; Mitsuyasu, Ronald T.; Hoffman, Risa M.

    2015-01-01

    Introduction Rates of abnormal visual inspection with acetic acid (VIA) and prevalence of high-risk human papillomavirus (HPV) subtypes have not been well characterized in HIV-infected women in Malawi. Methods We performed a prospective cohort study of VIA (N=440) in HIV-infected women ages 25-59, with a nested study of HPV subtypes in first 300 women enrolled. Wilcoxon's Rank-Sum Test was used to compare continuous variables and Fisher's exact test was used to compare categorical variables between women with normal versus abnormal VIA. Results: Of 440 women screened, 9.5% (N=42) had abnormal VIA with 69.0% (N=29) having advanced disease not amenable to cryotherapy. Of 294 women with HPV results, 39% (N=114) of women were positive for high-risk HPV infection. Only lower CD4 count (287 cells/mm3 vs. 339 cells/mm3, p=0.03) and high-risk HPV (66.7% versus 35.6%, p<0.01) were associated with abnormal VIA. The most common high-risk HPV subtypes in women with abnormal VIA were 35 (33.3%), 16 (26.7%), and 58 (23.3%). Conclusion Low CD4 cell count was associated with abnormal VIA and raises the importance of early ART and expanded availability of VIA. HPV vaccines targeting additional non-16/18 high-risk HPV subtypes may have greater protective advantages in countries such as Malawi. PMID:24928579

  14. Prospective Pilot Study of Consolidation Chemotherapy With Docetaxel and Cisplatin After Concurrent Chemoradiotherapy for Advanced Head and Neck Cancer

    SciTech Connect

    Lee, Kyun Chan; Lee, Seok Ho; Lee, Yuna; Park, Se Hoon Park, Jinny; Cho, Eun Kyung; Shin, Dong Bok; Lee, Jae Hoon; Kim, Dong Young; Kim, Seon Tae

    2008-05-01

    Purpose: With the improvement concurrent chemoradiotherapy (CCRT) in the management of patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC), distant failures have become a more relevant problem in terms of survival. The primary objective of this Phase II study is to assess the feasibility of docetaxel and cisplatin consolidation after primary CCRT for patients with HNSCC. Methods and Materials: Patients with locoregionally advanced HNSCC received chemotherapy with three cycles of cisplatin, 100 mg/m{sup 2}, on Days 1, 22, and 43. Concurrent radiotherapy to the primary tumor and neck was given in a daily dose of 2 Gy to a total dose of 70-70.2 Gy over 7 weeks. After completion of CCRT, patients without evidence of disease progression received an additional four cycles of consolidation chemotherapy with docetaxel, 75 mg/m{sup 2}, and cisplatin, 75 mg/m{sup 2}, every 3 weeks. Results: Of 33 patients, 27 (81%) completed CCRT. After CCRT, three complete and 19 partial responses were recorded, giving an overall response rate of 67%. Of 19 patients who went to the consolidation phase, only 4 (21%) received all four cycles of docetaxel and cisplatin. Causes of failure of consolidation chemotherapy were toxicity in 11 patients, including three treatment-related deaths, and progression in 4 patients. Three patients died of sepsis during the consolidation phase. Median survival was 11 months for all patients and 8 months for those treated with consolidation chemotherapy. Conclusion: The poor compliance and high incidence of severe toxicities prompted no further evaluation of this consolidation chemotherapy after CCRT.

  15. Effects of a Parallel Arm Randomized Controlled Weight Loss Pilot Study on Biological and Psychosocial Parameters of Overweight and Obese Breast Cancer Survivors

    USDA-ARS?s Scientific Manuscript database

    Background: Weight gain often occurs after breast cancer (BC) diagnosis, and obesity along with sedentary behavior, are associated with increased risk of BC recurrence and mortality. The purpose of this study was to examine effects of weight loss and exercise on body composition, fitness, cancer-rel...

  16. Development and evaluation of a culturally sensitive support group programme for Chinese-Australian women with breast cancer: a pilot study.

    PubMed

    Kwok, C; Ho, M

    2011-11-01

    Cancer support groups are an important vehicle for providing informational and psychosocial support to cancer survivors. Studies suggest that people from minority cultures are underrepresented in cancer support groups. The aims of this study were to report the development and evaluation of a culturally sensitive support group programme for Chinese-Australian women with breast cancer and to evaluate the informational and psychosocial impact of the programme. In collaboration with a Chinese cancer support organisation, 29 women were enrolled in the programme which was evaluated by a combination of quantitative and qualitative approaches. The results indicated that the programme was well received by the participants who suggested that the content was useful and relevant. In addition, the findings indicated that the programme, designed to be culturally sensitive and linguistically appropriate, was effective in providing informational support and psychosocial support for the participants. A methodology for giving breast cancer survivors a sense of interconnectedness and thus minimising their feelings of isolation and helplessness, were also among the chief outcomes of this study. The study provided some insight into the development of supportive cancer survivorship care for women being treated for breast cancer in the Australian-Chinese community.

  17. DCE-MRI parameters have potential to predict response of locally advanced breast cancer patients to neoadjuvant chemotherapy and hyperthermia: a pilot study.

    PubMed

    Craciunescu, Oana I; Blackwell, Kimberly L; Jones, Ellen L; Macfall, James R; Yu, Daohai; Vujaskovic, Zeljko; Wong, Terence Z; Liotcheva, Vlayka; Rosen, Eric L; Prosnitz, Leonard R; Samulski, Thaddeus V; Dewhirst, Mark W

    2009-01-01

    and the WiP and WoP were combined into a MPTS with the intent of achieving better prognostic efficacy. The MPTS was correlated with response to NA therapy as determined by pathological residual tumour and MRI imaging. The contrast agent in all tumours typically peaked in the first 1-4 min. The tumours' WiP and WoP varied considerably. The MPTS was highly correlated with whether the patients had a pathological response. This scoring system has a specificity of 78% and a sensitivity of 91% for predicting response to NA chemotherapy. The kappa was 0.69 with a 95% confidence interval of [0.38, 1] and a p-value of 0.002. This pilot study shows that the MPTS derived using pre-treatment MRI images has the potential to predict response to NA ChT and HT in LABC patients. Further prospective studies are needed to confirm the validity of these results.

  18. Pilot Study of the Use of Hybrid Multidimensional T2-Weighted Imaging-DWI for the Diagnosis of Prostate Cancer and Evaluation of Gleason Score.

    PubMed

    Sadinski, Meredith; Karczmar, Gregory; Peng, Yahui; Wang, Shiyang; Jiang, Yulei; Medved, Milica; Yousuf, Ambereen; Antic, Tatjana; Oto, Aytekin

    2016-09-01

    The objective of our study was to evaluate the role of a hybrid T2-weighted imaging-DWI sequence for prostate cancer diagnosis and differentiation of aggressive prostate cancer from nonaggressive prostate cancer. Twenty-one patients with prostate cancer who underwent preoperative 3-T MRI and prostatectomy were included in this study. Patients underwent a hybrid T2-weighted imaging-DWI examination consisting of DW images acquired with TEs of 47, 75, and 100 ms and b values of 0 and 750 s/mm(2). The apparent diffusion coefficient (ADC) and T2 were calculated for cancer and normal prostate ROIs at each TE and b value. Changes in ADC and T2 as a function of increasing the TE and b value, respectively, were analyzed. A new metric termed "PQ4" was defined as the percentage of voxels within an ROI that has increasing T2 with increasing b value and has decreasing ADC with increasing TE. ADC values were significantly higher in normal ROIs than in cancer ROIs at all TEs (p < 0.0001). With increasing TE, the mean ADC increased 3% in cancer ROIs and increased 12% in normal ROIs. T2 was significantly higher in normal ROIs than in cancer ROIs at both b values (p ≤ 0.0002). The mean T2 decreased with increasing b value in cancer ROIs (ΔT2 = -17 ms) and normal ROIs (ΔT2 = -52 ms). PQ4 clearly differentiated normal ROIs from prostate cancer ROIs (p = 0.0004) and showed significant correlation with Gleason score (ρ = 0.508, p < 0.0001). Hybrid MRI measures the response of ADC and T2 to changing TEs and b values, respectively. This approach shows promise for detecting prostate cancer and determining its aggressiveness noninvasively.

  19. A pilot study to evaluate assisted freehand ultrasound elasticity imaging in the sizing of early breast cancer: a comparison of B-mode and AFUSON elasticity ultrasound with histopathology measurements

    PubMed Central

    English, R E; Li, J; Parker, A J C; Roskell, D; Adams, R F; Parulekar, V; Baldwin, J; Chi, Y; Noble, J A

    2011-01-01

    Objective This pilot study investigates the role of assisted-freehand ultrasound (AFUSON) elasticity imaging of the breast in assessing the contour, size and area of 23 early breast cancers by making comparison of AFUSON with the equivalent B-mode ultrasound images and gold standard histopathology slides. Methods The B-mode, AFUSON and digitised histopathology slides of three early breast cancers were compared for contour, size and area with histopathology scans. AFUSON features that corresponded to areas of known malignant change on the histopathology slides were regarded as diagnostic. These diagnostic criteria were then applied to the B-mode and AFUSON elasticity images of all 23 breast cancers in the pilot study without having the availability of the histopathology scans for reference. Corresponding diameters were measured and the results were compared with the equivalent measurements on the scans of the histology slides. The results were tabulated in histogram form. Diagnostic confidence levels were evaluated. Results Size dimension accuracy increased from 66% using B-mode alone to 82% using combined B-mode and AFUSON elasticity images. Tumour area accuracy was also increased. A small number of cases had a striking visual similarity of shape on AFUSON elasticity scans and histopathology slides. Conclusion In spite of the shortfalls in this study, AFUSON elasticity imaging was capable of acquiring some high-quality images that showed strong correlation between AFUSON elasticity and scans of histology slides. Further studies will be carried out to refine the technique and determine if it has a role in the diagnosis and management of breast cancer. PMID:21632651

  20. Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival: Protocol of an Online Pilot Cohort Study.

    PubMed

    Catany Ritter, Anna; Egger, Annarita Sabrina; Machacek, Jennifer; Aspalter, Rosa

    2016-07-29

    Current evidence suggests that the incidence of cancer is low in vegan populations, and experimental studies have revealed a significant role of dietary proteins in cancer development and progression. However, little data currently exists regarding the effect of a plant-based diet on the progression of diagnosed cancer. The main objective of this study is to determine if a reduction or total elimination of animal protein from the diet can positively influence the outcome of an existing cancer and, in addition to standard oncological therapies, increase remission rates. The primary aim of this online study is to test the effect on remission rates in cancer patients (primary outcome) with distinct self-selected dietary patterns (omnivore, lacto-ovo-vegetarian, vegan), and allow for an estimation of the effect size. Secondary outcomes are tumor behavior, relapse-free interval, therapies, therapy tolerability and side-effects, comorbidities, medication, quality of life, acceptance, and feasibility of the selected diet. Safety concerns exist for vegan diets (especially in cancer patients) and the study will carefully monitor for deterioration of health, tumor progression, or malnutrition. Furthermore, the study will evaluate the online portal as a study platform (technical and safety aspects, and sequence of displayed questionnaires) as well as the validity of self-reported and online-generated data. The study was performed between April, 2015 and June, 2016, and a preliminary evaluation of safety aspects was undertaken after June, 2016. Primary and secondary outcomes will be evaluated when the final patients complete the study in December, 2016. This study will reveal information about the effects of dietary patterns on cancer disease and progression. The methodology of the study addresses several aspects and limitations of nutrition studies in cancer patients, such as precision of nutrition data, acceptance criteria, online methodology, and safety aspects

  1. A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer.

    PubMed

    Cetina, Lucely; Crombet, Tania; Jiménez-Lima, Roberto; Zapata, Sergio; Ramos, Mayra; Avila, Sandra; Coronel, Jaime; Charco, Eduardo; Bojalil, Rafael; Astudillo, Horacio; Bazán, Blanca; Dueñas-González, Alfonso

    2015-01-01

    Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. Cervical cancer patients who are refractory or progressive to first-line chemotherapy have a dismal prognosis, and no second- or third-line chemotherapy is considered standard. This pilot trial aimed to evaluate the efficacy and safety of nimotuzumab in 17 patients with pre-treated advanced refractory or progressive cervical cancer. Nimotuzumab was administered weekly at 200 mg/m(2) as single agent for 4 weeks (induction phase), then concurrent with 6 21-day cycles of gemcitabine (800 mg/m(2)) or cisplatin (50 mg/m(2)) for 18 weeks (concurrent phase) and then once every 2 weeks (maintenance phase). Nimotuzumab could be continued beyond disease progression. Seventeen patients were accrued and evaluated for safety and efficacy. The median number of nimotuzumab applications was 20 (5-96). The median number of chemotherapy cycles administered was 6 (1-6). No toxicity occurred during induction and maintenance phases (single agent nimotuzumab). In the concurrent phase, grade 3 toxicity events observed were leucopenia, anemia and diarrhea in 11.7%, 5.8% and 11.7% respectively. No complete or partial responses were observed. The stable disease (SD) rate was 35%. The median PFS and OS rates were 163 days (95% CI, 104 to 222), and 299 days (95% IC, 177 to 421) respectively. Nimotuzumab is well tolerated and may have a role in the treatment of advanced cervical cancer.

  2. A Fitbit and Facebook mHealth intervention for promoting physical activity among adolescent and young adult childhood cancer survivors: A pilot study.

    PubMed

    Mendoza, Jason A; Baker, K Scott; Moreno, Megan A; Whitlock, Kathryn; Abbey-Lambertz, Mark; Waite, Alan; Colburn, Trina; Chow, Eric J

    2017-06-15

    Physical activity (PA) may be important for preventing chronic diseases for adolescent and young adult (AYA) childhood cancer survivors. Randomized controlled trials (RCTs) of PA interventions for AYA survivors are sparse, but necessary to determine effective programs for increasing PA among this population. Thus, we conducted a pilot RCT, testing the feasibility of a mobile health (mHealth) intervention to promote PA among AYA survivors. We recruited 14- to 18-year-olds who were ≥1-year post cancer therapy from Seattle Children's Hospital. The 10-week intervention consisted of a wearable PA-tracking device (Fitbit Flex) and a peer-based virtual support group (Facebook group). Research staff helped set step goals and awarded badges weekly. Controls received usual care. Baseline assessments occurred before randomization and follow-up assessments occurred during weeks 8-10 of the intervention period. Feasibility criteria are defined below. Qualitative interviews assessed acceptability. Exploratory outcomes included PA, quality of life, and motivation for PA. All feasibility criteria were met: we recruited 60 survivors, intervention participants wore the Fitbit on the majority (71.5%) of intervention days, and ≥90% of all participants completed questionnaires. Qualitative data confirmed intervention acceptability. Exploratory analyses found no significant adjusted group differences for change in moderate-to-vigorous PA (4.4 vs. 5.0 min/day; P = 0.92) or sedentary time (-4.5 vs. 1.0 min/day; P = 0.73), comparing intervention subjects to controls. Some modest differences were found for select subscales of quality of life and motivation for PA. This mHealth PA intervention was feasible and acceptable to AYA childhood cancer survivors and warrants a fully powered RCT. © 2017 Wiley Periodicals, Inc.

  3. Modulation of Breast Cancer Risk Biomarkers by High-Dose Omega-3 Fatty Acids: Phase II Pilot Study in Premenopausal Women.

    PubMed

    Fabian, Carol J; Kimler, Bruce F; Phillips, Teresa A; Box, Jessica A; Kreutzjans, Amy L; Carlson, Susan E; Hidaka, Brandon H; Metheny, Trina; Zalles, Carola M; Mills, Gordon B; Powers, Kandy R; Sullivan, Debra K; Petroff, Brian K; Hensing, Whitney L; Fridley, Brooke L; Hursting, Stephen D

    2015-10-01

    Higher intakes of the omega-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to the omega-6 arachidonic acid (AA) have been variably associated with reduced risk of premenopausal breast cancer. The purpose of this pilot trial was to assess feasibility and explore the effects of high-dose EPA and DHA on blood and benign breast tissue risk biomarkers before design of a placebo-controlled phase IIB trial. Premenopausal women with evidence of hyperplasia ± atypia by baseline random periareolar fine needle aspiration were given 1860 mg of EPA + 1500 mg of DHA ethyl esters daily for 6 months. Blood and benign breast tissue were sampled during the same menstrual cycle phase prestudy and a median of 3 weeks after last dose. Additional blood was obtained within 24 hours of last dose. Feasibility, which was predefined as 50% uptake, 85% retention, and 70% compliance, was demonstrated with 46% uptake, 94% completion, and 85% compliance. Cytologic atypia decreased from 77% to 38% (P = 0.002), and Ki-67 from a median of 2.1% to 1.0% (P = 0.021) with an increase in the ratio of EPA + DHA to AA in erythrocyte phospholipids but no change in blood hormones, adipokines, or cytokines. Exploratory breast proteomics assessment showed decreases in several proteins involved in hormone and cytokine signaling with mixed effects on those in the AKT/mTOR pathways. Further investigation of EPA plus DHA for breast cancer prevention in a placebo-controlled trial in premenopausal women is warranted. ©2015 American Association for Cancer Research.

  4. Bladder Cancer Segmentation in CT for Treatment Response Assessment: Application of Deep-Learning Convolution Neural Network-A Pilot Study.

    PubMed

    Cha, Kenny H; Hadjiiski, Lubomir M; Samala, Ravi K; Chan, Heang-Ping; Cohan, Richard H; Caoili, Elaine M; Paramagul, Chintana; Alva, Ajjai; Weizer, Alon Z

    2016-12-01

    Assessing the response of bladder cancer to neoadjuvant chemotherapy is crucial for reducing morbidity and increasing quality of life of patients. Changes in tumor volume during treatment is generally used to predict treatment outcome. We are developing a method for bladder cancer segmentation in CT using a pilot data set of 62 cases. 65 000 regions of interests were extracted from pre-treatment CT images to train a deep-learning convolution neural network (DL-CNN) for tumor boundary detection using leave-one-case-out cross-validation. The results were compared to our previous AI-CALS method. For all lesions in the data set, the longest diameter and its perpendicular were measured by two radiologists, and 3D manual segmentation was obtained from one radiologist. The World Health Organization (WHO) criteria and the Response Evaluation Criteria In Solid Tumors (RECIST) were calculated, and the prediction accuracy of complete response to chemotherapy was estimated by the area under the receiver operating characteristic curve (AUC). The AUCs were 0.73 ± 0.06, 0.70 ± 0.07, and 0.70 ± 0.06, respectively, for the volume change calculated using DL-CNN segmentation, the AI-CALS and the manual contours. The differences did not achieve statistical significance. The AUCs using the WHO criteria were 0.63 ± 0.07 and 0.61 ± 0.06, while the AUCs using RECIST were 0.65 ± 007 and 0.63 ± 0.06 for the two radiologists, respectively. Our results indicate that DL-CNN can produce accurate bladder cancer segmentation for calculation of tumor size change in response to treatment. The volume change performed better than the estimations from the WHO criteria and RECIST for the prediction of complete response.

  5. Bladder Cancer Segmentation in CT for Treatment Response Assessment: Application of Deep-Learning Convolution Neural Network—A Pilot Study

    PubMed Central

    Cha, Kenny H.; Hadjiiski, Lubomir M.; Samala, Ravi K.; Chan, Heang-Ping; Cohan, Richard H.; Caoili, Elaine M.; Paramagul, Chintana; Alva, Ajjai; Weizer, Alon Z.

    2017-01-01

    Assessing the response of bladder cancer to neoadjuvant chemotherapy is crucial for reducing morbidity and increasing quality of life of patients. Changes in tumor volume during treatment is generally used to predict treatment outcome. We are developing a method for bladder cancer segmentation in CT using a pilot data set of 62 cases. 65 000 regions of interests were extracted from pre-treatment CT images to train a deep-learning convolution neural network (DL-CNN) for tumor boundary detection using leave-one-case-out cross-validation. The results were compared to our previous AI-CALS method. For all lesions in the data set, the longest diameter and its perpendicular were measured by two radiologists, and 3D manual segmentation was obtained from one radiologist. The World Health Organization (WHO) criteria and the Response Evaluation Criteria In Solid Tumors (RECIST) were calculated, and the prediction accuracy of complete response to chemotherapy was estimated by the area under the receiver operating characteristic curve (AUC). The AUCs were 0.73 ± 0.06, 0.70 ± 0.07, and 0.70 ± 0.06, respectively, for the volume change calculated using DL-CNN segmentation, the AI-CALS and the manual contours. The differences did not achieve statistical significance. The AUCs using the WHO criteria were 0.63 ± 0.07 and 0.61 ± 0.06, while the AUCs using RECIST were 0.65 ± 007 and 0.63 ± 0.06 for the two radiologists, respectively. Our results indicate that DL-CNN can produce accurate bladder cancer segmentation for calculation of tumor size change in response to treatment. The volume change performed better than the estimations from the WHO criteria and RECIST for the prediction of complete response. PMID:28105470

  6. A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer

    PubMed Central

    Cetina, Lucely; Crombet, Tania; Jiménez-Lima, Roberto; Zapata, Sergio; Ramos, Mayra; Avila, Sandra; Coronel, Jaime; Charco, Eduardo; Bojalil, Rafael; Astudillo, Horacio; Bazán, Blanca; Dueñas-González, Alfonso

    2015-01-01

    Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. Cervical cancer patients who are refractory or progressive to first-line chemotherapy have a dismal prognosis, and no second- or third-line chemotherapy is considered standard. This pilot trial aimed to evaluate the efficacy and safety of nimotuzumab in 17 patients with pre-treated advanced refractory or progressive cervical cancer. Nimotuzumab was administered weekly at 200 mg/m2 as single agent for 4 weeks (induction phase), then concurrent with 6 21-day cycles of gemcitabine (800 mg/m2) or cisplatin (50 mg/m2) for 18 weeks (concurrent phase) and then once every 2 weeks (maintenance phase). Nimotuzumab could be continued beyond disease progression. Seventeen patients were accrued and evaluated for safety and efficacy. The median number of nimotuzumab applications was 20 (5–96). The median number of chemotherapy cycles administered was 6 (1-6). No toxicity occurred during induction and maintenance phases (single agent nimotuzumab). In the concurrent phase, grade 3 toxicity events observed were leucopenia, anemia and diarrhea in 11.7%, 5.8% and 11.7% respectively. No complete or partial responses were observed. The stable disease (SD) rate was 35%. The median PFS and OS rates were163 days (95% CI, 104 to 222), and 299 days (95% IC, 177 to 421) respectively. Nimotuzumab is well tolerated and may have a role in the treatment of advanced cervical cancer. PMID:25802932

  7. Piloting a generic cancer consumer quality index in six European countries.

    PubMed

    Wind, Anke; Roeling, Mark Patrick; Heerink, Jana; Sixma, Herman; Presti, Pietro; Lombardo, Claudio; van Harten, Wim

    2016-09-02

    Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries. The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors. A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation. This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care.

  8. Using Appearance-Based Messages to Increase Sun Protection in Adolescent Young Adult Cancer Survivors: A Pilot Study of Ultraviolet Light Photography.

    PubMed

    Recklitis, Christopher J; Bakan, Jennifer; Werchniak, Andrew E; Mahler, Heike

    2017-09-01

    Despite risk for secondary skin cancers, many adolescent and young adult (AYA) cancer survivors do not practice recommended sun protection (SP). Ultraviolet light photography (UVP), which demonstrates the negative impact of sun exposure on physical appearance, has been shown to increase SP in community AYA samples. This study of 58 AYA cancer survivors demonstrates that UVP is acceptable and not distressing to this population. Follow-up data on 23 AYAs demonstrated that those given UVP significantly improve their SP behaviors, while those receiving standard educational materials do not. Results demonstrate UVP is a promising tool for increasing SP in AYA survivors.

  9. Pilot clinical study of boron neutron capture therapy for recurrent hepatic cancer involving the intra-arterial injection of a (10)BSH-containing WOW emulsion.

    PubMed

    Yanagie, Hironobu; Higashi, Syushi; Seguchi, Koji; Ikushima, Ichiro; Fujihara, Mituteru; Nonaka, Yasumasa; Oyama, Kazuyuki; Maruyama, Syoji; Hatae, Ryo; Suzuki, Minoru; Masunaga, Shin-ichiro; Kinashi, Tomoko; Sakurai, Yoshinori; Tanaka, Hiroki; Kondo, Natsuko; Narabayashi, Masaru; Kajiyama, Tetsuya; Maruhashi, Akira; Ono, Koji; Nakajima, Jun; Ono, Minoru; Takahashi, Hiroyuki; Eriguchi, Masazumi

    2014-06-01

    A 63-year-old man with multiple HCC in his left liver lobe was enrolled as the first patient in a pilot study of boron neutron capture therapy (BNCT) involving the selective intra-arterial infusion of a (10)BSH-containing water-in-oil-in-water emulsion ((10)BSH-WOW). The size of the tumorous region remained stable during the 3 months after the BNCT. No adverse effects of the BNCT were observed. The present results show that (10)BSH-WOW can be used as novel intra-arterial boron carriers during BNCT for HCC.

  10. Can A Complex Online Intervention Improve Cancer Nurses' Pain Screening and Assessment Practices? Results from a Multicenter, Pre-post Test Pilot Study.

    PubMed

    Phillips, Jane L; Heneka, Nicole; Hickman, Louise; Lam, Lawrence; Shaw, Tim

    2017-04-01

    Unrelieved cancer pain has an adverse impact on quality of life. While routine screening and assessment forms the basis of effective cancer pain management, it is often poorly done, thus contributing to the burden of unrelieved cancer pain. The aim of this study was to test the impact of an online, complex, evidence-based educational intervention on cancer nurses' pain assessment capabilities and adherence to cancer pain screening and assessment guidelines. Specialist inpatient cancer nurses in five Australian acute care settings participated in an intervention combining an online spaced learning cancer pain assessment module with audit and feedback of pain assessment practices. Participants' self-perceived pain assessment competencies were measured at three time points. Prospective, consecutive chart audits were undertaken to appraise nurses' adherence with pain screening and assessment guidelines. The differences in documented pre-post pain assessment practices were benchmarked and fed back to all sites post intervention. Data were analyzed using inferential statistics. Participants who completed the intervention (n = 44) increased their pain assessment knowledge, assessment tool knowledge, and confidence undertaking a pain assessment (p < .001). The positive changes in nurses' pain assessment capabilities translated into a significant increasing linear trend in the proportion of documented pain assessments in patients' charts at the three time points (χ(2) trend = 18.28, df = 1, p < .001). There is evidence that learning content delivered using a spaced learning format, augmented with pain assessment audit and feedback data, improves inpatient cancer nurses' self-perceived pain screening and assessment capabilities and strengthens cancer pain guideline adherence.

  11. Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

    PubMed

    Carney, Patricia A; Tucker, Erin K; Newby, Timothy A; Beer, Tomasz M

    2014-03-01

    This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hun