Trials / Completed
CompletedNCT00020995
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
Effects of a Low Fat Diet on Serum Factors and Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- Male
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | therapeutic dietary intervention |
Timeline
- Start date
- 2001-08-01
- Completion
- 2010-01-01
- First posted
- 2003-01-27
- Last updated
- 2013-09-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00020995. Inclusion in this directory is not an endorsement.