Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must be ≥18 years of age.
Breast tumor ≥1 cm.
Not currently taking dietary supplements containing fish oil or omega-3 PUFAs. A diet containing fish meat is permitted.
Unilateral and/or bilateral diagnostic breast mammogram and/or ultrasound within 60 days of enrollment. If breast MRI is done per treating physician's discretion, at least one breast imaging modality should be within 60 days of enrollment.
Disqualifiers
American Joint Committee on Cancer (AJCC) clinical M1 breast cancer (i.e., with distant metastasis).
Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol treatment or providing informed consent.
Trial design
Design model
Single group
Treatments tested in this trial
Mini rTG OMEGA-3 Fish Oil
DrugSubjects will take six (6) soft gel capsules daily.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Dietary InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lipid species in primary breast tumors
The number of subjects with increased levels of DHA-containing and EPA-containing lipid species in primary breast tumors.
Time frame
Up to 32 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: