- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383835
Study of Moderate Dose Omega 3 Fatty Acid Supplement in Premenopausal Women at High Risk for Breast Cancer
Feasibility Study of Moderate Dose Omega 3 Fatty Acid Supplementation in Premenopausal Women at High Risk for Breast Cancer Considering Future Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy and breast feeding are protective when they occur at an early age, typically at an age less than 30. The influence of pregnancy on breast cancer risk is not fully understood, and little is known about modulation of the breast microenvironment during pregnancy and its influence on risk. Hormones, including rising estrogen levels, play a role in fatty acid synthesis. In pre-clinical models, a rise in omega-3:omega-6 ratio occurs naturally in the breast of pregnant mice. This may be able to be accentuated in human breast tissue with omega-3 fatty acid supplementation. Omega-3 fatty acid supplementation has been shown to favorably modulate breast cancer risk and risk biomarkers in pre-menopausal women at high risk for breast. Omega-3 fatty acid supplementation during pregnancy has also been found to have positive outcomes for the offspring, making it an ideal intervention to study in this population.
This pilot study of omega-3 supplementation in pre-menopausal women at high risk for breast cancer who are still considering pregnancy is addressing a potential prevention strategy in a population otherwise excluded from breast cancer prevention trials and not eligible for standard of care chemoprevention. With this pilot, the intent is to establish feasibility, document tolerability, determine number of women needed to enroll based on pregnancy rate and identify biomarkers for future investigation. This information will provide necessary data to apply for future extramural funding for a larger randomized trial. In a larger randomized trial with longer follow up, we will be able to assess post-pregnancy breast tissue and biomarkers to examine efficacy of omega-3 fatty acid supplementation in breast cancer risk reduction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
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Westwood, Kansas, United States, 66205
- The University of Kansas Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women age 21 - 40 must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiol.
- Women must be considered at high risk for breast cancer based on family history (first or second degree relative diagnosed with breast cancer under the age of 60), prior precancerous biopsy or a 5-year Gail model risk estimate of ≥ 1.7% or 10 year Tyrer-Cuzick risk of 2x population risk as listed in the model.
- Women must indicate that they are still considering future pregnancy and childbearing.
- Women must be one year from pregnancy and breast-feeding.
- Women must be willing to take supplemental omega-3 fatty acids provided by the study.
Exclusion Criteria:
- Women actively undergoing in-vitro fertilization or fertility treatments are excluded.
- Women currently pregnant or breast-feeding at time of study consent.
- Women with an active malignancy.
- Women on anticoagulation.
- Women with bilateral breast implants or tram flap reconstruction.
- Women who have had radiation to both breasts.
- Women with current mammographic or clinical breast exam mass which is suspicious for breast cancer and malignancy has not been ruled out.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3 Supplementation
Participants will take the dose of omega-3 supplementation (600mg DHA and 300mg EPA) daily for 6 months.
|
DHA 600 milligrams (mg) per day for 6 months EPA 300mg per day for 6 months |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Follow-up visit completion rate
Time Frame: 6 months
|
Defined as the overall completion of 80% of follow-up visits study-wide.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy rate
Time Frame: 6 months
|
Pregnancy will be assessed by review of patient record.
|
6 months
|
Discontinuation rate of omega-3 supplementation
Time Frame: 6 months
|
Discontinuation rate will be assessed by patient reported compliance.
|
6 months
|
Incidence of microbiome in collected breast tissue
Time Frame: 6 months
|
Microbiome will be assessed with random periareolar fine-needle aspiration (RPFNA)
|
6 months
|
Identify presence of biomarkers
Time Frame: 6 months
|
Biomarkers will be assessed by RPFNA
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauren Nye, MD, The University of Kansas - Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Moderate Dose Omega-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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