This phase II trial studies how well omega-3 fatty acids work in decreasing side effects from aromatase inhibitor therapy in patients with stage 0-III breast cancer. Aromatase inhibitor medications have been shown to be very effective for treating breast cancer, however, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects like joint pain and stiffness. Patients taking omega-3 fatty acid supplements may improve symptoms of joint pain and stiffness when taking an aromatase inhibitor. This study is being done to test whether taking omega-3 fatty acid supplement soon after starting an aromatase inhibitor may reduce the likelihood of having bothersome symptoms.
Additional locations may be listed on ClinicalTrials.gov for NCT04268134.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To investigate the effects of omega-3 fatty acids (O3-FA) supplementation in the setting of concomitant aromatase inhibitor (AI) therapy on oxylipin profiles.
SECONDARY OBJECTIVES:
I. To investigate the effects of AI therapy with or without O3-FA supplementation on oxylipin profiles.
II. To examine the effects of omega-3 fatty acids (O3-FA) supplementation on the proportion of patients who develop AI-associated musculoskeletal symptoms (AIMSS) within 9 months of AI initiation.
III. To examine the effects of omega-3 fatty acids (O3-FA) supplementation on the proportion of patients who discontinue AI therapy because of musculoskeletal symptoms within 9 months of AI initiation.
IV. To examine the effects of omega-3 fatty acids (O3-FA) supplementation on the proportion of patients who discontinue AI therapy because of toxicity within 9 months of AI initiation.
EXPLORATORY OBJECTIVES:
I. To examine the impact of estrogen deprivation with aromatase inhibition on stimulated inflammatory responses.
II. To analyze associations between change in inflammatory responses and patient-reported symptoms, including pain measures.
III. To explore changes in gene expression in inflammatory cells with change in symptoms.
OUTLINE:
Beginning 12 weeks after standard aromatase inhibitor therapy initiation, patients receive omega-3-acid ethyl esters orally (PO) once daily (QD) or twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 15 and 27 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Michigan Comprehensive Cancer Center
Principal InvestigatorNorah Lynn Henry