Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00020995|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: therapeutic dietary intervention||Phase 2|
- Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet.
- Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines.
- Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients.
- Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.
- Arm II: Patients receive a control diet containing the standard amounts of fat and fiber.
PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Effects of a Low Fat Diet on Serum Factors and Prostate Cancer|
|Study Start Date :||August 2001|
|Actual Study Completion Date :||January 2010|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020995
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1738|
|Study Chair:||William Aronson, MD||Jonsson Comprehensive Cancer Center|