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

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

January 13, 2010

Start Date ^ICMJE

August 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00020995 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of a Low Fat Diet on Serum Factors and Prostate Cancer

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Primary Purpose:  Prevention

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Procedure: therapeutic dietary intervention

Study Arms / Comparison Groups

Publications *

Aronson WJ, Barnard RJ, Freedland SJ, Henning S, Elashoff D, Jardack PM, Cohen P, Heber D, Kobayashi N. 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. 2010 Jan;183(1):345-50.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00020995

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068737, UCLA-0001030, NCI-G01-1973

Study Sponsor ^ICMJE

Jonsson Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

William Aronson, MD

Jonsson Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP