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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00020995

Enrollment

Unknown

Registered

2003-01-27

Start date

2001-08-31

Completion date

2010-01-31

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Brief 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.

Interventions

PROCEDUREtherapeutic dietary intervention

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Eligibility

Sex/Gender

MALE

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the prostate * Previously untreated and on watchful waiting * Medically able to receive dietary intervention PATIENT CHARACTERISTICS: Age: * 40 to 80 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially prepared foods PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent luteinizing hormone-releasing hormone agonists (leuprolide or goserelin) * No concurrent androgen-receptor blocking agents (flutamide or bicalutamide) * No concurrent testosterone * No concurrent insulin * No concurrent finasteride Radiotherapy: * Not specified Surgery: * No prior orchiectomy Other: * No concurrent saw palmetto supplement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026