Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients with Stage I-III Breast Cancer

Inclusion Criteria

• Post-menopausal status, as defined by institutional guidelines; concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed
• Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the Food and Drug Administration (FDA)-approved AIs (anastrozole, exemestane, letrozole)
• Concurrent breast related radiation therapy is allowed
• Prior tamoxifen use is allowed
• Prior chemotherapy is allowed
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Metastatic malignancy of any kind
• Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
• AI use > 21 days prior to study enrollment OR AI use > 180 days prior to study enrollment if most recently assessed pain score is 3 or below
• Known bleeding disorders
• Current use of warfarin or other anticoagulants
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
• Pregnant or nursing women
• Known sensitivity or allergy to fish or fish oil
• Unable to give informed consent