Clinical Trials /

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

NCT02295059

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Omega 3 Fatty Acids and ERPR(-)<span class="go-doc-concept go-doc-biomarker">HER2</span>(+/-) <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Prevention

Title

  • Brief Title: Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
  • Official Title: Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention
  • Clinical Trial IDs

    NCT ID: NCT02295059

    ORG ID: OSU-13130

    NCI ID: 1R01CA164019-01A1

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    The investigators 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    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

    Eligibility Criteria

    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 2 years or less from completion of standard
    therapy.

    - Greater than 1 year from pregnancy, lactation.

    - Mammogram within the six 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
    or NSAID-containing products.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue

    Secondary Outcome Measures

    Changes in cytomorphology and/or cell proliferation of mammary epithelial cells

    Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue

    Trial Keywords

    Breast cancer

    ERPR negative

    HER-2/neu overexpression positive or negative