Back to resultsOmega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omega 3 fatty acids
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, ERPR negative, HER-2/neu overexpression positive or negative
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.
Sites / Locations
- City of Hope Medical Center
- The Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Omega 3 fatty acids - high dose
Omega 3 fatty acids - low dose
Arm Description
~5 g EPA+DHA in 5 capsules per day
~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day
Outcomes
Primary Outcome Measures
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
Biomarker
Secondary Outcome Measures
Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
Biomarker
Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
Biomarker
Full Information
NCT ID
NCT02295059
First Posted
October 14, 2014
Last Updated
February 21, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02295059
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, ERPR negative, HER-2/neu overexpression positive or negative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega 3 fatty acids - high dose
Arm Type
Experimental
Arm Description
~5 g EPA+DHA in 5 capsules per day
Arm Title
Omega 3 fatty acids - low dose
Arm Type
Experimental
Arm Description
~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3 fatty acids
Other Intervention Name(s)
fish oil, eicosapentaenoic acid, docosahexaenoic acid
Intervention Description
supplied as soft gelatin capsules for oral administration
Primary Outcome Measure Information:
Title
Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue
Description
Biomarker
Time Frame
Baseline to up to 12 months
Secondary Outcome Measure Information:
Title
Changes in cytomorphology and/or cell proliferation of mammary epithelial cells
Description
Biomarker
Time Frame
Baseline to up to 12 months
Title
Changes in DNA promoter methylation and pro-inflammatory gene expression in mammary epithelial and adipose tissue
Description
Biomarker
Time Frame
Baseline to up to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa D Yee, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention
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