Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020995
First received: July 11, 2001
Last updated: February 18, 2011
Last verified: May 2004
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Effects of a Low Fat Diet on Serum Factors and Prostate Cancer

Resource links provided by NLM:

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

Publications:

ClinicalTrials.gov Identifier: NCT00020995     History of Changes
Other Study ID Numbers: CDR0000068737, UCLA-0001030, NCI-G01-1973
Study First Received: July 11, 2001
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

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
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013