omega-3 fatty acids in preventing joint symptoms in patients with stage i-iii breast cancer receiving anastrozole, exemestane, or letrozole

Conditions: Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this randomized pilot trial studies omega-3 fatty acid in preventing joint symptoms in patients with stage i-iii breast cancer receiving anastrozole, exemestane, or letrozole. omega-3 fatty acid supplement may lessen or prevent joint stiffness or pain in patients receiving hormone therapy for breast cancer.

objectives: i. to assess the feasibility of evaluating joint symptoms in postmenopausal women with breast cancer randomized to n-3 pufa (omega-3 fatty acid) vs. placebo supplementation using the functional assessment of cancer therapy-breast (fact-b) and endocrine subscale (fact-es), brief pain inventory (bpi) and stanford's health assessment -disability index (has) during the first 6 months of adjuvant aromatase inhibitor (ai) therapy. ii. to preliminarily evaluate the efficacy of n-3 pufa vs. placebo supplementation on ai induced joint symptoms. iii. to explore blood and imaging based biomarkers (plasma and red blood cell \[rbc\] levels of n-3 pufas, inflammatory cytokines and receptors, and intra-articular tenosynovial inflammation by musculoskeletal magnetic resonance imaging \[mri\] imaging) of ai-induced joint symptoms in women on ai therapy randomized to n-3 pufas vs. placebo supplementation. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive omega-3 fatty acid orally (po) once daily (qd) for 6 months in the absence of disease progression or unacceptable toxicity. arm ii: patients receive placebo po qd for 6 months in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * women diagnosed with breast cancer stages i-iii initiating first adjuvant ai therapy with any of the food and drug administration- (fda) approved ais (anastrozole, 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 * history of osteoarthritis and/or fibromyalgia 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, with the exception of osteoarthritis and fibromyalgia * ai use \> 2 weeks prior to study enrollment * known bleeding disorders * history of diabetes mellitus, heart disease or tia/stroke * 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 regular or any other supplements that might interact with n-3 pufa supplements within six months of study initiation; sporadic use of n-3 pufa supplement may be eligible if there has been a 3-month washout period prior to randomization * pregnant or nursing women * known sensitivity or allergy to fish or fish oil * concurrent use of daily full dose aspirin (≥ 325 mg/day), nonsteroidal anti-inflammatory drugs (nsaids) or nsaid-containing products or steroids; one month washout period is required prior to randomization * unable to give informed consent * in patients consenting for optional mris, any contraindication to mri examination including but not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia

Keywords: breast cancer