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
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
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.
GOG-0225 CAN DIET AND PHYSICAL ACTIVITY MODULATE OVARIAN, FALLOPIAN TUBE AND PRIMARY PERITONEAL CANCER
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.