Clinical Trials Directory

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

TypeNameDescription
PROCEDUREtherapeutic 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.