Omega 3 Fatty Acids for Breast Cancer Prevention

Palo Alto (17 mi)

Overseen byLisa D Yee, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The study aims to determine biological changes associated with a low vs high dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over 12 months in women at risk for recurrent breast cancer. The objectives of the trial are to develop mammary epithelial, adipose tissue specific markers of exposure and response to omega 3 fatty acid supplements that can be carried forward into definitive intervention trials of omega 3 fatty acids for breast cancer prevention. The investigators will randomize 80 subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast cancer to either a high or low dose of omega 3 fatty acids. Using fine needle aspiration to procure cellular samples of breast epithelial and adipose tissue, the investigators will determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.

Eligibility Criteria

This trial is for women who've had Stage 0 to III breast cancer that's hormone receptor negative and HER-2/neu positive or negative. They should be done with major treatments like chemotherapy for at least six months, not currently pregnant or nursing, and without other cancers or serious illnesses that could interfere with the study.

Treatment Details

The study tests how different doses of omega 3 fatty acids (DHA and EPA) affect biological markers in breast tissue over a year. Women will be randomly assigned to either a high or low dose group, and researchers will use fine needle aspiration to collect cell samples from their breasts.

2Treatment groups

Experimental Treatment

Group I: Omega 3 fatty acids - low doseExperimental Treatment1 Intervention

\~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day

Group II: Omega 3 fatty acids - high doseExperimental Treatment1 Intervention

\~5 g EPA+DHA in 5 capsules per day