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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA164019-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 fatty acids - high dose | Experimental | ~5 g EPA+DHA in 5 capsules per day |
|
| Omega 3 fatty acids - low dose | Experimental | ~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega 3 fatty acids | Dietary Supplement | supplied as soft gelatin capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue | Biomarker | Baseline to up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cytomorphology and/or cell proliferation of mammary epithelial cells | Biomarker | Baseline to up to 12 months |
| Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa D Yee, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| The Ohio State University Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41891042 | Derived | Frankhouser DE, Yin HH, Belury MA, Newman JW, Yee LD. High- versus low-dose dietary n-3 PUFA treatment produces mixed effects on DNA methylation and epigenetic fidelity in breast adipose tissue. medRxiv [Preprint]. 2026 Mar 22:2026.03.18.26348746. doi: 10.64898/2026.03.18.26348746. | |
| 40288580 | Derived | Frankhouser DE, DeWees T, Snodgrass IF, Cole RM, Steck S, Thomas D, Kalu C, Belury MA, Clinton SK, Newman JW, Yee LD. Randomized dose-response trial of n-3 fatty acids in hormone receptor negative breast cancer survivors - impact on breast adipose oxylipin and DNA methylation patterns. Am J Clin Nutr. 2025 Jul;122(1):70-82. doi: 10.1016/j.ajcnut.2025.04.021. Epub 2025 Apr 25. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| D015118 | Eicosapentaenoic Acid |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
Biomarker
| Baseline to up to 12 months |
| Columbus |
| Ohio |
| 43210 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D015777 | Eicosanoids |