Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07643428
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mini rTG OMEGA-3 Fish Oil — DRUG
    Subjects will take six (6) soft gel capsules daily.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dietary Intervention
    Mini rTG OMEGA-3 fish oil is a commercially available dietary supplement in the form of soft gel capsules.

Primary Outcome Measure

Lipid species in primary breast tumors [ Time Frame: Up to 32 weeks ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Lubna Chaudhary, MD, MS
414-805-4600

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