Status:
ACTIVE_NOT_RECRUITING
Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Alberta
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Docosahexaenoic acid (DHA) is an omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA). N-3 LCPUFA are essential fatty acids in the diet. The majority of n-3 LCPUFA in the diet is alpha-linolenic...
Eligibility Criteria
Inclusion
- Women with invasive (clinical stage I, II and III) breast cancer, for whom neoadjuvant systemic therapy with chemotherapy is recommended prior to surgery.
- ECOG Performance status of 0 or 1.
- Hematology and Biochemistry assessments (CBC and differential, PTT, PT/INR, AST, Alk Phos, Bilirubin, and Creatinine) within normal range unless determined not clinically significant by the qualified investigator.
- Ability to take oral medications.
- Adequate tissue specimen for diagnosis, biomarkers, and endpoint Ki67 assays.
Exclusion
- Patients undergoing surgery prior to chemotherapy.
- Current or previous (within 2 months) daily use (\>1 day/week) use of omega-3, fish oil, or other supplements or functional foods containing docosahexaenoic acid (at daily doses \> 200 mg).
- Known allergy to soy or corn.
- Continued intake of supplements containing Vitamin C, Vitamin E or β-carotene exceeding the DRI, or other anti-oxidant supplements.
- Symptomatic but untreated cholelithiasis.
- History of deep venous thrombosis, active thrombophlebitis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension, known inherited hypercoagulable disorder.
- Diagnosis of any other malignancy within the previous year except for adequately treated basal cell or squamous cell skin cancer.
- Medically documented history of a psychiatric disorder that would preclude consent
- Partial or complete loss of vision or diplopia, from ophthalmic vascular disease.
- Hypersensitivity to DHA or to any ingredient in the formulation or component of the container.
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2030
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03831178
Start Date
August 28 2019
End Date
September 1 2030
Last Update
June 26 2025
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2