TY - JOUR
T1 - Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain
AU - Lustberg, Maryam B.
AU - Orchard, Tonya S.
AU - Reinbolt, Raquel
AU - Andridge, Rebecca
AU - Pan, Xueliang
AU - Belury, Martha
AU - Cole, Rachel
AU - Logan, Amanda
AU - Layman, Rachel
AU - Ramaswamy, Bhuvaneswari
AU - Wesolowski, Robert
AU - Berger, Michael
AU - Patterson, Elaine
AU - Loprinzi, Charles
AU - Shapiro, Charles L.
AU - Yee, Lisa
N1 - Publisher Copyright:
© Springer Science+Business Media, LLC 2017.
PY - 2018/11/3
Y1 - 2018/11/3
N2 - 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 n − 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 n − 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) n − 3 PUFAs. Common toxicities included grade 1 flatulence (55% of both groups) and belching (45% of n − 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 (p = 0.04), but not the n − 3 group (p = 0.58), with a trend toward between-group differences (p = 0.06) at 12 weeks, but no significant differences at 24 weeks. RBC n − 3 levels were strongly positively correlated with FACT-ES at 12 weeks, but attenuated at 24 weeks. Conclusion High-dose n − 3 PUFA supplementation is feasible and well tolerated when administered with AIs. Additional studies are needed to evaluate efficacy in prevention of joint symptoms.
AB - 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 n − 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 n − 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) n − 3 PUFAs. Common toxicities included grade 1 flatulence (55% of both groups) and belching (45% of n − 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 (p = 0.04), but not the n − 3 group (p = 0.58), with a trend toward between-group differences (p = 0.06) at 12 weeks, but no significant differences at 24 weeks. RBC n − 3 levels were strongly positively correlated with FACT-ES at 12 weeks, but attenuated at 24 weeks. Conclusion High-dose n − 3 PUFA supplementation is feasible and well tolerated when administered with AIs. Additional studies are needed to evaluate efficacy in prevention of joint symptoms.
KW - Aromatase inhibitors
KW - Arthralgias
KW - Breast cancer survivors
KW - Joint symptoms
KW - Omega-3 fatty acids
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U2 - 10.1007/s10549-017-4559-z
DO - 10.1007/s10549-017-4559-z
M3 - Article
C2 - 29101597
AN - SCOPUS:85032787619
SN - 0167-6806
VL - 167
SP - 709
EP - 718
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
IS - 3
ER -