Biopsy of the Prostate |
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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.
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
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
William Aronson, MD, Study Chair, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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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