Status:
ACTIVE_NOT_RECRUITING
Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 r...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 22 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02295059
Start Date
August 9 2017
End Date
June 22 2026
Last Update
September 16 2025
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210