Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02295059 |
Recruitment Status :
Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : June 25, 2020
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Dietary Supplement: omega 3 fatty acids | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention |
Actual Study Start Date : | September 4, 2014 |
Estimated Primary Completion Date : | November 2020 |
Estimated Study Completion Date : | November 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Omega 3 fatty acids - high dose
~5 g EPA+DHA in 5 capsules per day
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Dietary Supplement: omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Other Names:
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Experimental: Omega 3 fatty acids - low dose
~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day
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Dietary Supplement: omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Other Names:
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- Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [ Time Frame: Baseline to up to 12 months ]Biomarker
- Changes in cytomorphology and/or cell proliferation of mammary epithelial cells [ Time Frame: Baseline to up to 12 months ]Biomarker
- Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue [ Time Frame: Baseline to up to 12 months ]Biomarker

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Prior diagnosis of Stage 0 to III breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy.
- Completion of chemotherapy or trastuzumab for > six months and of radiation therapy for > 2 months, as applicable and 5 years or less from completion of standard therapy.
- Greater than 1 year from pregnancy, lactation.
- Mammogram within the eight months prior to study enrollment that is not suspicious for breast cancer (ACR Class I-III).
Exclusion Criteria:
- Other current malignancy or metastatic malignancy of any kind.
- Ongoing chemotherapy, radiation therapy, or other cancer-related treatment.
- Subjects on Coumadin or other anticoagulants.
- Subjects with breast implants.
- Subjects who have had radiation to both breasts or who have undergone bilateral mastectomies.
- Barriers to fine needle aspiration sampling of breast adipose tissue and/or parenchymal breast tissue, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose/parenchymal tissue for adequate fine needle aspiration (FNA) sampling.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements.
- Chronic use of omega 3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega 3 fatty acid supplements.
- Pregnant or nursing women.
- Known sensitivity or allergy to fish.
- Subjects on a standing regimen of full dose aspirin (greater than 325 mg/day), NSAIDs (nonsteriodal anti inflammatory drug) or NSAID-containing products.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295059
United States, California | |
City of Hope Medical Center | |
Duarte, California, United States, 91010 | |
United States, Ohio | |
The Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Lisa D Yee, MD | City of Hope Medical Center |
Responsible Party: | City of Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT02295059 |
Other Study ID Numbers: |
16421 1R01CA164019-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | November 20, 2014 Key Record Dates |
Last Update Posted: | June 25, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast cancer ERPR negative HER-2/neu overexpression positive or negative |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |