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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00020995
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: therapeutic dietary intervention Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Official Title: Effects of a Low Fat Diet on Serum Factors and Prostate Cancer
Study Start Date : August 2001
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of adenocarcinoma of the prostate
  • Previously untreated and on watchful waiting
  • Medically able to receive dietary intervention



  • 40 to 80

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially prepared foods


Biologic therapy:

  • Not specified


  • 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


  • Not specified


  • No prior orchiectomy


  • No concurrent saw palmetto supplement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020995

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)
Study Chair: William Aronson, MD Jonsson Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00020995     History of Changes
Other Study ID Numbers: CDR0000068737
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: May 2004

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases