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

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ClinicalTrials.gov Identifier: NCT02295059
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : February 17, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE October 14, 2014
First Posted Date  ICMJE November 20, 2014
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE August 9, 2017
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [ Time Frame: Baseline to up to 12 months ]
Biomarker
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue [ Time Frame: Baseline to up to 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Changes in cytomorphology and/or cell proliferation of mammary epithelial cells [ Time Frame: Baseline to up to 12 months ]
    Biomarker
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
  • Changes in cytomorphology and/or cell proliferation of mammary epithelial cells [ Time Frame: Baseline to up to 12 months ]
  • Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue [ Time Frame: Baseline to up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
Official Title  ICMJE Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE Dietary Supplement: omega 3 fatty acids
supplied as soft gelatin capsules for oral administration
Other Names:
  • fish oil
  • eicosapentaenoic acid
  • docosahexaenoic acid
Study Arms  ICMJE
  • Experimental: Omega 3 fatty acids - high dose
    ~5 g EPA+DHA in 5 capsules per day
    Intervention: Dietary Supplement: omega 3 fatty acids
  • 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
    Intervention: Dietary Supplement: omega 3 fatty acids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02295059
Other Study ID Numbers  ICMJE 16421
1R01CA164019-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Lisa D Yee, MD City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP