Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
NCT ID: NCT02295059
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2017-08-09
2026-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Omega 3 fatty acids - high dose
\~5 g EPA+DHA in 5 capsules per day
omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Omega 3 fatty acids - low dose
\~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day
omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Interventions
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omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Lisa D Yee, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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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.
Other Identifiers
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16421
Identifier Type: -
Identifier Source: org_study_id
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