Effects of a Low Fat Diet on Serum Factors and Prostate Cancer
40 Years
80 Years
Male
Prostate Cancer
Trial Information
Effects of a Low Fat Diet on Serum Factors and 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Prevention
Principal Investigator
William Aronson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068737
NCT ID:
NCT00020995
Start Date:
August 2001
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
