Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Effects of a Low Fat Diet on Serum Factors and Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020995
• Other study ID #: CDR0000068737
• Secondary ID: UCLA-0001030NCI-
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: September 19, 2013
• Start date: August 2001
• Est. completion date: January 2010

Study information

• Verified date: May 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• therapeutic dietary intervention

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aronson WJ, Barnard RJ, Freedland SJ, Henning S, Elashoff D, Jardack PM, Cohen P, Heber D, Kobayashi N. Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate — View Citation