Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention - Full Text View

Sponsor:	University of California, Los Angeles
Collaborators:	National Institutes of Health (NIH) National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00836615

Purpose

Men who are scheduled for radical prostatectomy are considered candidates for this study. Six weeks prior to surgery, the subject will undergo screening procedures to determine eligibility. If eligible, the subject will be randomized to one of two four-week nutrition programs - either a balanced Western Diet or a low-fat diet with fish oil capsules. The UCLA GCRC (General Clinical Research Center) chefs will prepare breakfast, lunch, and dinner, and meals will be delivered to subjects in coolers two days per week. Subjects will require a minimum of four visits to the UCLA GCRC.

Condition	Intervention
Prostate Cancer	Dietary Supplement: Western Diet Dietary Supplement: Low-fat diet

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

fat acid ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Western Diet: Experimental Subjects assigned to this arm will receive a western diet which will be prepared by UCLA's General Clinical Research Center and delivered 2 to 3 times per week.	Dietary Supplement: Western Diet Western diet (prepared by General Clinical Research Center) received 2 to 3 times per week for 4 weeks.
Low-fat diet: Experimental A low-fat diet with fish oil capsules will be assigned to patients which will be prepared by General Clinical Research Center and delivered 2 to 3 times per week. In addition, this group will be asked to take 5 fish oil capsules per day.	Dietary Supplement: Low-fat diet Low-fat diet with fish oil capsules (prepared by General Clinical Research Center) received 2 to 3 times per week for 4 weeks.

Detailed Description:

Experiments have shown that a low fat diet high in fish oil may prevent the progression of prostate cancer. The purpose of this study is to determine if a low-fat diet combined with fish oil capsules will change the chemical substances present in blood and prostate tissue that are related to the growth of cancer cells. This study will compare how these substances are affected by either, a typical high-fat Western diet, or a low-fat diet combined with fish oil.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has been diagnosed with adenocarcinoma (cancer)
Able to sign the consents to participate.
Is medically able to receive and comply with the dietary intervention.
Accessible geographically and by telephone for nutritional counseling and follow up.
Has elected to undergo radical prostatectomy.
Agrees to stop taking dietary or vitamin supplements (Lycopene, Vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto, PC-SPES) for 1 week prior to starting the study.
Can safely stop taking aspirin, COX-2 inhibitors, and other anti-inflammatory medications for 1 week prior to starting the study.
Can safely stop taking fish oil capsules 2-weeks prior to starting the diet intervention.

Exclusion Criteria:

Is taking LHRH agonists, androgen receptor blocking agents or finasteride.
Has undergone bilateral orchiectomy.
Has a bleeding disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836615

Contacts

Contact: William Aronson, MD

310-825-6301

waronson@ucla.edu

Locations

United States, California
University of California, Los Angeles	Recruiting
Los Angeles, California, United States, 90095
Contact: William Aronson, MD 310-825-6301 waronson@ucla.edu
Principal Investigator: William Aronson, MD
Sub-Investigator: Pinchas Cohen, MD
Sub-Investigator: John Glaspy, MD, MPH
Sub-Investigator: Christopher Saigal, MD

Sponsors and Collaborators

University of California, Los Angeles

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William Aronson, MD

University of California, Los Angeles

More Information

No publications provided

Responsible Party:	University of California, Los Angeles ( William Aronson, MD )
Study ID Numbers:	01-07-026-14, P50 CA 92131-01A1
Study First Received:	February 3, 2009
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00836615 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Low-fat diet
Western diet
fish oil capsules

prostate cancer
UCLA
radical prostatectomy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009