Low-Fat Fish Oil Diet for Prostate Cancer Prevention

NCT ID: NCT00798876

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-18
• Study Completion Date: 2018-02-12

Brief Summary

Studies on patterns of how many men get prostate cancer in other countries show that environment contributes to the high incidence of prostate cancer in the United States. Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of getting prostate cancer. Although the exact nature of the effects of diet are not completely known, the amount of fat eaten appears to affect the number of men who get prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from fish and is quite different from the type of fat from animals and vegetables (omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood test indications, called markers, have been discovered that would show the effect working.

Study doctors designed this study to try to find markers in the blood tests of men who have prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil helps reduce those markers, hence indicating that it helps reduce the cancer in these men. These men will be compared to men with prostate cancer whose diets do not contain the fish-oil fat.

The men chosen will have prostate cancer and be scheduled for operations to have their prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the beginning of the diet. After the 4-to-8-week period, they will have their operations. Their blood will be checked again and a sample of their removed prostate will be examined to tell if the diet had any effect on the cancer and its markers.

Detailed Description

1. To establish and validate intermediate biomarkers for prostate cancer prevention trials by conducting a dietary intervention trial of a low-fat diet with omega-3 fatty acid supplements in men undergoing radical prostatectomy. In initial trials it was feasible to intervene with diet and obtain tissue and serum for bioassay and biomarker development. This aim is to study the effect a low-fat, high omega-3 diet has on serum and tissue biomarkers from patients who have prostatectomies for prostate cancer. Ultimately, we hope to identify and validate intermediate markers of efficacy for large-scale dietary prevention trials.

2. To establish and validate insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer prevention trials. IGF-1 is a peptide growth factor that is important to the growth and progression of prostate cancer. To our knowledge, no prospective dietary intervention studies have evaluated the effect of a low-fat diet with omega-3 fatty acid supplements on IGF-1 and IGFBPs, and their potential to serve as relevant intermediate markers for low-fat dietary intervention trials for prostate cancer prevention.

3. To establish and validate serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer prevention trials. We will evaluate if men randomized to a low-fat, fish-oil-supplemented diet have increased serum ratios of omega-3:omega-6 fatty acids compared with men randomized to a control Western diet before radical prostatectomy. We also will study if patients in the low-fat, fish oil arm have increased ratios of membrane omega-3:omega-6 fatty acids as well as decreased COX-2 and decreased PGE-2 levels in benign and malignant tissue and in visceral fat. If so, it will proved further evidence to support the potential of low-fat fish oil diets for prostate cancer prevention. If serum omega-3:omega-6 ratios correlate with changes in COX-2 and PGE-2 in tissues, then serum omea-3:omega-6 ratios may be useful for monitoring activity and efficacy of low-fat fish-oil-supplemented diets in future trials.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard Western Diet

Subjects will be asked to consume a standard Western Diet for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).

Group Type: PLACEBO_COMPARATOR

Western Diet

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.

Medical Examination

Intervention Type: OTHER

Subjects will have a routine medical exam.

Dietary Interview

Intervention Type: OTHER

Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.

Blood Draw

Intervention Type: OTHER

40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

Radical Prostatectomy

Intervention Type: PROCEDURE

Subjects will undergo a radical prostatectomy as part of their standard of care.

Low-Fat Diet

Subjects will be asked to consume a low fat diet with fish oil and vitamin E supplements for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).

Group Type: EXPERIMENTAL

Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.

Vitamin E supplement

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.

Low-Fat Diet

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.

Medical Examination

Intervention Type: OTHER

Subjects will have a routine medical exam.

Dietary Interview

Intervention Type: OTHER

Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.

Blood Draw

Intervention Type: OTHER

40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

Radical Prostatectomy

Intervention Type: PROCEDURE

Subjects will undergo a radical prostatectomy as part of their standard of care.

Interventions

Fish Oil

Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E supplement

Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Western Diet

Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.

Intervention Type: DIETARY_SUPPLEMENT

Low-Fat Diet

Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.

Intervention Type: DIETARY_SUPPLEMENT

Medical Examination

Subjects will have a routine medical exam.

Intervention Type: OTHER

Dietary Interview

Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.

Intervention Type: OTHER

Blood Draw

40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

Intervention Type: OTHER

Radical Prostatectomy

Subjects will undergo a radical prostatectomy as part of their standard of care.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Eligibility Criteria:

• Patient consents to participate.
• Medically able to receive and comply with the diet.
• Lives near enough for counseling and follow-up.
• Has elected to have operation to remove prostate.
• Agrees to stop diet or vitamin supplements or herbal supplements for 1 week before the study begins.
• Patient able to stop taking aspirin, COX-2 inhibitors, and other anti-inflammatory medications for 1 week before study start.
• Patient able to safely stop taking fish oil capsules 2 weeks before the diet starts.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Aronson, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA and Western Los Angles VA

Locations

West Los Angeles VA

Los Angeles, California, United States

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

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Other Identifiers

P50CA092131-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-002610

Identifier Type: OTHER

Identifier Source: secondary_id

01-07-026

Identifier Type: -

Identifier Source: org_study_id

NCT00836615

Identifier Type: -

Identifier Source: nct_alias