Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain.

Purpose: Aromatase inhibitor (AI)-induced joint symptoms negatively impact drug adherence and quality of life in breast cancer survivors. Mechanisms underlying symptoms may include inflammation. It is hypothesized that <italic>n</italic> − 3 polyunsaturated fatty acids (PUFAs) have anti-inflammatory properties and may reduce symptoms.Methods: We conducted a randomized, double-blind, placebo-controlled study comparing 4.3 g/day <italic>n</italic> − 3 PUFA supplements vs placebo for 24 weeks in postmenopausal breast cancer patients starting adjuvant AIs. Primary endpoints were adherence and tolerability; secondary outcomes included inflammatory cytokines and symptoms assessed by the Brief Pain Inventory short form (BPI-SF) and Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) at 0, 12, and 24 weeks.Results: Forty-four women were randomized, of which 35 completed the study. Adherence was ≥ 88% based on these 35 patients with pill counts as well as change in red blood cell (RBC) <italic>n</italic> − 3 PUFAs. Common toxicities included grade 1 flatulence (55% of both groups) and belching (45% of <italic>n</italic> − 3 group). Mean pain severity scores (BPI-SF) did not change significantly by time or treatment arm. Quality of life, based on FACT-ES scores, significantly decreased within placebo (<italic>p</italic> = 0.04), but not the <italic>n</italic> − 3 group (<italic>p</italic> = 0.58), with a trend toward between-group differences (<italic>p</italic> = 0.06) at 12 weeks, but no significant differences at 24 weeks. RBC <italic>n</italic> − 3 levels were strongly positively correlated with FACT-ES at 12 weeks, but attenuated at 24 weeks.Conclusion: High-dose <italic>n</italic> − 3 PUFA supplementation is feasible and well tolerated when administered with AIs. Additional studies are needed to evaluate efficacy in prevention of joint symptoms. [ABSTRACT FROM AUTHOR]