Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors
NCT07643428 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-06-11
Summary
This is a single-arm Phase 2 interventional treatment study to investigate changes in tissue lipidomes with omega-3 polyunsaturated fatty acids (PUFA) supplementation and correlations with pathological response in patients with early-stage breast cancer. Patients will be treated with a dietary supplement enriched with omega-3 PUFA (O3Supp) for 4 to 28 weeks prior to surgical resection of a breast tumor(s). Concurrent standard-of-care neoadjuvant treatment with clinically indicated systemic agents (such as chemotherapy, endocrine therapy, anti-HER2 therapy, immunotherapy) is allowed.
Conditions
Interventions
- DRUG
-
Mini rTG OMEGA-3 Fish Oil
Subjects will take six (6) soft gel capsules daily.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Lubna Chaudhary, MD, MS · Medical College of Wisconsin
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2028-06-01
- Completion
- 2028-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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