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OBJECTIVES: I. Determine the results of two nutritional regimens on amounts of prostate-specific antigen (PSA) in patients with cancer of the prostate. II. Determine the compliance of those patients using the nutritional regimen. III. Assess the results of the nutritional regimen on quality of existence during these patients. IV. Assess the results of the nutritional regimen on PSA anxiety during these patients. V. Assess the results of the nutritional regimen on weight problems, high bloodstream pressure, and serum cholesterol during these patients.
OUTLINE: This can be a randomized study. People are stratified based on previous treatment (prostatectomy versus radiotherapy) and prostate-specific antigen (PSA) level (under 5 mg/mL versus 5 or greater mg/mL). All patients complete quality of existence, nutritional, along with other questionnaires before, during, and following the research. People are randomized to 1 of 2 nutritional intervention regimens: Arm I (Intensive Dietary Intervention): People are allotted to consume a low-fat, high fiber diet that’s also full of soy, vegetables and fruit, eco-friendly tea, and e vitamin. Patients consult nutritionist for diet education and nutritional counseling weekly for 8 days, then every 2 days for just two several weeks, after which monthly for 14 several weeks. Sessions include nutritional counseling, meal planning, and instruction in skills essential to maintain nutritional changes in lifestyle. Patients record their nutritional intake regularly. Arm II (General Dietary Instruction): People are allotted to follow nutritional guidelines established through the National Cancer Institute. Patients consult nutritionist for nutritional counseling and monitoring every 2 several weeks for 18 several weeks. Patients on arms have PSA levels tested prior to the study, one and three several weeks in to the study, after which every 3 several weeks after that for approximately 18 several weeks.
Forecasted ACCRUAL: As many as 154 patients is going to be accrued with this study over 24 months.
Resourse: https://clinicaltrials.gov/ct2/show/
