Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Prevention | Closed | 40 to 80 | NCI | UCLA-0001030 NCI-G01-1973, NCT00020995 |
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.
Entry Criteria
Disease Characteristics:
- Diagnosis of adenocarcinoma of the prostate
- Previously untreated and on watchful waiting
- Medically able to receive dietary intervention
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
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
Expected Enrollment
A total of 40 patients (20 per arm) will be accrued for this study within 6 months.
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.
Aronson WJ, Barnard RJ, Freedland SJ, et al.: Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate cancer. J Urol 183 (1): 345-50, 2010.[PUBMED Abstract]
Trial Lead Organizations
Jonsson Comprehensive Cancer Center at UCLA
 | | | |
| William Aronson, MD, Protocol chair | |
| |
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| Registry Information | ||
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| Official Title | Effects of a Low Fat Diet on Serum Factors and Prostate Cancer | |
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| Trial Start Date | 2001-08-09 | |
| ||
| Registered in ClinicalTrials.gov | NCT00020995 | |
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| Date Submitted to PDQ | 2001-05-11 | |
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| Information Last Verified | 2004-05-18 | |
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| NCI Grant/Contract Number | P30-CA16042 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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