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.
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
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
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 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