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PURPOSE: Randomized phase III trial to compare the effectiveness of two diets, differing in fat, fiber, soy, fruit, vegetable, vitamin E, and green tea content, in affecting PSA level in patients with prostate cancer.
OBJECTIVES: I. Determine the effects of 2 dietary regimens on levels of prostate-specific antigen (PSA) in patients with prostate cancer. II. Determine the compliance of these patients with the dietary regimen. III. Evaluate the effects of the dietary regimen on quality of life in these patients. IV. Evaluate the effects of the dietary regimen on PSA anxiety in these patients. V. Evaluate the effects of the dietary regimen on obesity, high blood pressure, and serum cholesterol in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to previous treatment (prostatectomy vs radiotherapy) and prostate-specific antigen (PSA) level (less than 5 mg/mL vs 5 or greater mg/mL). All patients complete quality of life, dietary, and other questionnaires before, during, and at the conclusion of the study. Patients are randomized to one of two dietary intervention regimens: Arm I (Intensive Nutritional Intervention): Patients are assigned to follow a low fat, high fiber diet that is also high in soy, fruits and vegetables, green tea, and vitamin E. Patients meet with a nutritionist for nutrition education and dietary counseling weekly for 8 weeks, then every 2 weeks for 2 months, and then monthly for 14 months. Sessions include dietary counseling, meal planning, and instruction in skills necessary to maintain dietary lifestyle changes. Patients record their dietary intake on a regular basis. Arm II (General Nutritional Instruction): Patients are assigned to follow dietary guidelines established by the National Cancer Institute. Patients meet with a nutritionist for dietary counseling and monitoring every 2 months for 18 months. Patients on both arms have PSA levels tested before the study, 1 and 3 months into the study, and then every 3 months thereafter for up to 18 months.
PROJECTED ACCRUAL: A total of 154 patients will be accrued for this study over 2 years.
Allocation: Randomized, Primary Purpose: Treatment
green tea, soy protein isolate, vitamin E
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:45-0400
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