Expired Study
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Los Angeles, California 90095


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.


Study summary:

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.


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


NCT ID:

NCT00020995


Primary Contact:

Study Chair
William Aronson, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 16, 2017

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