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

PRIMARY OBJECTIVES:

I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA)
supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).

SECONDARY OBJECTIVES:

I. To prospectively define the population most at risk for developing AIIAs by the
identification and validation of genetic risk predictors and to develop a single nucleotide
polymorphism (SNP)/gene profile predictive of treatment intervention response.

OUTLINE: Patients are randomized to 1 of 2 groups.

Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for
6 months.

Group II: Patients receive placebo PO QD for 6 months.

After completion of study, patients will be followed up periodically.

Inclusion Criteria:

- Women diagnosed with breast cancer stages I-III initiating first line adjuvant
aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole,
exemestane, letrozole)

- Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed;
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

- 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 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