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

This study is ongoing, but not recruiting participants.

First Received: July 11, 2001 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020995

Purpose

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	Intervention	Phase
Prostate Cancer	Procedure: therapeutic dietary intervention	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
Official Title:	Effects of a Low Fat Diet on Serum Factors and Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diets Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2001

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020995

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1738

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

William Aronson, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068737, UCLA-0001030, NCI-G01-1973
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00020995 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009