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

This study is ongoing, but not recruiting participants.

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

MedlinePlus related topics:   Cancer    Prostate Cancer   

U.S. FDA Resources

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

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


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

Study ID Numbers:   CDR0000068737, UCLA-0001030, NCI-G01-1973
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00020995
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

ClinicalTrials.gov processed this record on October 10, 2008




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