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Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02295059
Collaborator
National Cancer Institute (NCI) (NIH)
80
Enrollment
2
Locations
2
Arms
63.7
Anticipated Duration (Months)
40
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: omega 3 fatty acids
 N/A

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 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 Design

Study Type:
Interventional
Anticipated 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 :
Aug 9, 2017
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Omega 3 fatty acids - high dose

~5 g EPA+DHA in 5 capsules per day

Dietary Supplement: omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Other Names:
  • fish oil
  • eicosapentaenoic acid
  • docosahexaenoic acid

    		•
    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

    Dietary Supplement: omega 3 fatty acids
    supplied as soft gelatin capsules for oral administration
    Other Names:
  • fish oil
  • eicosapentaenoic acid
  • docosahexaenoic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [Baseline to up to 12 months]

      Biomarker

    Secondary Outcome Measures

    1. Changes in cytomorphology and/or cell proliferation of mammary epithelial cells [Baseline to up to 12 months]

      Biomarker

    2. Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue [Baseline to up to 12 months]

      Biomarker

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010
    2 The Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Lisa D Yee, MD, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT02295059
    Other Study ID Numbers:
    • 16421
    • 1R01CA164019-01A1
    First Posted:
    Nov 20, 2014
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by City of Hope Medical Center
    Breast cancer
    ERPR negative
    HER-2/neu overexpression positive or negative
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jun 9, 2022