Status:
UNKNOWN
Study of Moderate Dose Omega 3 Fatty Acid Supplement in Premenopausal Women at High Risk for Breast Cancer
Lead Sponsor:
Lauren Nye
Collaborating Sponsors:
University of Kansas Medical Center
American Cancer Society, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-40 years
Phase:
NA
Brief Summary
This pilot study is an investigation of feasibility of moderate dose omega-3 fatty acid supplementation in pre-menopausal women at high risk for breast cancer who are considering future pregnancy. The...
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 k...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03383835
Start Date
February 5 2018
End Date
March 1 2024
Last Update
May 23 2023
Active Locations (1)
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1
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205