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.
The study aims to determine biological changes that occur with a 12 month intervention of low (\~0.9 g EPA+DHA/day) vs high dose (\~5.4 g EPA+DHA/day) of omega 3 polyunsaturated fatty acids (PUFAs) in women survivors of hormone unresponsive breast cancer. The objectives of the trial are to develop unique 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 EPA, DHA/omega 3 PUFAs 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 PUFAs. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
supplied as soft gelatin capsules for oral administration
City of Hope Medical Center
Duarte, California, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
Biomarker
Time frame: Baseline to up to 12 months
Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
Biomarker
Time frame: Baseline to up to 12 months
Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
Biomarker
Time frame: Baseline to up to 12 months
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