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

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

  • ORG STUDY ID: 16421
  • SECONDARY ID: 1R01CA164019-01A1
  • NCT ID: NCT02295059

Conditions

  • Breast Cancer

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Omega 3 fatty acids - high doseExperimental~5 g EPA+DHA in 5 capsules per day
    Omega 3 fatty acids - low doseExperimental~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 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.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
      Time Frame:Baseline to up to 12 months
      Safety Issue:
      Description:Biomarker

      Secondary Outcome Measures

      Measure:Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
      Time Frame:Baseline to up to 12 months
      Safety Issue:
      Description:Biomarker
      Measure:Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
      Time Frame:Baseline to up to 12 months
      Safety Issue:
      Description:Biomarker

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Active, not recruiting
      Lead Sponsor:City of Hope Medical Center

      Trial Keywords

      • Breast cancer
      • ERPR negative
      • HER-2/neu overexpression positive or negative

      Last Updated

      February 17, 2021