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Study Title Principal Investigator
A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy
PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer. II. To evaluate the compliance with a controlled diet intervention. III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to controls. OUTLINE: Patients are randomized to 1 or 2 treatment arms. ARM I: Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 24 hours after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts. Patients meet with the study dietician within 3 weeks of enrollment and prior to, or on the day of, their first course of chemotherapy on study and at the start of each subsequent course. ARM II: Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
Recruiting | Breast Cancer | Not Multisite
Tanya Dorff
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GOG-0225 CAN DIET AND PHYSICAL ACTIVITY MODULATE OVARIAN, FALLOPIAN TUBE AND PRIMARY PERITONEAL CANCER PROGRESSION-FREE SURVIVAL?
Ovarian cancer is diagnosed in approximately 22,430 women annually in the United States. The Gynecological Oncology Group affords a unique opportunity to test hypotheses relating dietary intake and increased physical activity to improved progression-free survival among women diagnosed with ovarian cancer.The lifestyle intervention, which consist of 20% total energy as dietary fat, greater than 6 colorful vegetables and fruit servings, plus 4,000+ additional steps daily, included in this protocol is consistent with national and international recommendations for cancer prevention and survival.Primay Objective:To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for Stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention will have significantly increased progressionfree survival compared to similar women who are randomized to a usual carecomparison group.Study Population:Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis.Study Arms:Women will be randomized 1:1 to intervention versus control and randomization will include stratification according to consolidation therapy (yes/no) as well as stage at diagnosis (II, III, or IV)Endpoints:Patients experiencing a recurrence of disease or a second primary cancer event will have reached the targeted study endpoint.Follow up:follow-up will be at 3 month intervals for the first 2 years, 6 month intervals for the next 3 years, and annually thereafter.Analysis:The overall effectiveness of the intervention will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no). Progression-free survival time for those who are still alive and have not been observed to fail by study end will be treated as censored observations.
Recruiting | Stomach Cancer | Multisite
Huyen Pham
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