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


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Prostate Diseases

Benign Prostatic Hypertrophy; Prostate Disease; Prostate Enlargement; Prostatitis


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

This study is no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.

PURPOSE: Randomizedphase 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 Treatment or Intervention Phase
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
 Procedure: cancer prevention intervention
 Procedure: dietary intervention
Phase II

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Phase II Randomized Study of the Effects of a Low Fat, High Fiber Diet on Serum Factors in Patients With Prostate Cancer

Further Study Details: 

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   -   80 Years,  Genders Eligible for Study:  Both

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

Location Information


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

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068737; UCLA-0001030; NCI-G01-1973
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020995
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 9, 2005
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