Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 goal of this pilot study is to determine feasibility of the study, document compliance with omega-3 fatty acid supplementation in this population and identify novel biomarkers modulated by moderate dose omega-3 fatty acids in this population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega-3 Supplementation | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omega-3 Supplementation
- description
- Participants will take the dose of omega-3 supplementation (600mg DHA and 300mg EPA) daily for 6 months.
- interventionNames
- Dietary Supplement: Omega-3 Supplementation
Primary outcomes (1)
- measure
- Follow-up visit completion rate
- timeFrame
- 6 months
- description
- Defined as the overall completion of 80% of follow-up visits study-wide.
Secondary outcomes (4)
- measure
- Pregnancy rate
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available