Phase
Condition
Breast Cancer
Cancer
Treatment
Docosahexaenoic acid (DHA)
Placebo oral capsule
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women with invasive (clinical stage I, II and III) breast cancer, for whomneoadjuvant 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, AlkPhos, Bilirubin, and Creatinine) within normal range unless determined notclinically significant by the qualified investigator.
Ability to take oral medications.
Adequate tissue specimen for diagnosis, biomarkers, and endpoint Ki67 assays.
Exclusion
Exclusion Criteria:
Patients undergoing surgery prior to chemotherapy.
Current or previous (within 2 months) daily use (>1 day/week) use of omega-3, fishoil, or other supplements or functional foods containing docosahexaenoic acid (atdaily doses > 200 mg).
Known allergy to soy or corn.
Continued intake of supplements containing Vitamin C, Vitamin E or β-caroteneexceeding 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, untreatedhypertension, known inherited hypercoagulable disorder.
Diagnosis of any other malignancy within the previous year except for adequatelytreated 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 thecontainer.
Study Design
Connect with a study center
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
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