Low-Fat Fish Oil Diet for Prostate Cancer Prevention

NCT00798876 | Completed DMC

• 3 other identifiers: 01-07-026P50CA092131-01A111-002610
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• check for insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer

  4 weeks

Secondary Outcomes (1)

• Check serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer

  4 weeks

Study Arms (2)

Standard Western Diet

PLACEBO COMPARATOR

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).

Dietary Supplement: Western Diet; Other: Medical Examination; Other: Dietary Interview; Other: Blood Draw; Procedure: Radical Prostatectomy

Low-Fat Diet

EXPERIMENTAL

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).

Dietary Supplement: Fish Oil; Dietary Supplement: Vitamin E supplement; Dietary Supplement: Low-Fat Diet; Other: Medical Examination; Other: Dietary Interview; Other: Blood Draw; Procedure: Radical Prostatectomy

Interventions

Fish Oil DIETARY_SUPPLEMENT

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

Low-Fat Diet

Vitamin E supplement DIETARY_SUPPLEMENT

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

Low-Fat Diet

Western Diet DIETARY_SUPPLEMENT

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

Standard Western Diet

Low-Fat Diet DIETARY_SUPPLEMENT

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

Low-Fat Diet

Medical Examination OTHER

Subjects will have a routine medical exam.

Low-Fat Diet; Standard Western Diet

Dietary Interview 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.

Low-Fat Diet; Standard Western Diet

Blood Draw OTHER

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

Low-Fat Diet; Standard Western Diet

Radical Prostatectomy PROCEDURE

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

Low-Fat Diet; Standard Western Diet

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

West Los Angeles VA

Los Angeles, California, 90073, United States

Location

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fish Oils; Diet, Western; Diet, Fat-Restricted; Independent Medical Evaluation; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William Aronson, MD

  UCLA and Western Los Angles VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: December 18, 2001
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (2)