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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02295059
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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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
Breast Cancer Dietary Supplement: omega 3 fatty acids Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 4, 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [ Time Frame: Baseline to up to 12 months ]
    Biomarker


Secondary Outcome Measures :
  1. Changes in cytomorphology and/or cell proliferation of mammary epithelial cells [ Time Frame: Baseline to up to 12 months ]
    Biomarker

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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295059


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
United States, Ohio
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
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Principal Investigator: Lisa D Yee, MD City of Hope Medical Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02295059    
Other Study ID Numbers: 16421
1R01CA164019-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases