The Effect of a Low Fat Diet, High in Soy, Fruits, Vegetables, Green Tea, Vitamin E and Fiber on the PSA 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
Moshe Shike, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|