Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|