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

Maryam B. Lustberg, Tonya S. Orchard, Raquel Reinbolt, Rebecca Andridge, Xueliang Pan, Martha Belury, Rachel Cole, Amanda Logan, Rachel Layman, Bhuvaneswari Ramaswamy, Robert Wesolowski, Michael Berger, Elaine Patterson, Charles Lawrence Loprinzi, Charles L. Shapiro, Lisa Yee

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalBreast Cancer Research and Treatment
DOIs
StateAccepted/In press - Nov 3 2017

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Musculoskeletal Pain
Aromatase Inhibitors
Endocrine Gland Neoplasms
Omega-3 Fatty Acids
Placebos
Pain
Joints
Eructation
Erythrocytes
Quality of Life
Breast Neoplasms
Flatulence
Equipment and Supplies
Therapeutics
Survivors
Anti-Inflammatory Agents
Cytokines
Inflammation
Pharmaceutical Preparations

Keywords

  • Aromatase inhibitors
  • Arthralgias
  • Breast cancer survivors
  • Joint symptoms
  • Omega-3 fatty acids

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain. / Lustberg, Maryam B.; Orchard, Tonya S.; Reinbolt, Raquel; Andridge, Rebecca; Pan, Xueliang; Belury, Martha; Cole, Rachel; Logan, Amanda; Layman, Rachel; Ramaswamy, Bhuvaneswari; Wesolowski, Robert; Berger, Michael; Patterson, Elaine; Loprinzi, Charles Lawrence; Shapiro, Charles L.; Yee, Lisa.

In: Breast Cancer Research and Treatment, 03.11.2017, p. 1-10.

Research output: Contribution to journalArticle

Lustberg, MB, Orchard, TS, Reinbolt, R, Andridge, R, Pan, X, Belury, M, Cole, R, Logan, A, Layman, R, Ramaswamy, B, Wesolowski, R, Berger, M, Patterson, E, Loprinzi, CL, Shapiro, CL & Yee, L 2017, 'Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain', Breast Cancer Research and Treatment, pp. 1-10. https://doi.org/10.1007/s10549-017-4559-z
Lustberg, Maryam B. ; Orchard, Tonya S. ; Reinbolt, Raquel ; Andridge, Rebecca ; Pan, Xueliang ; Belury, Martha ; Cole, Rachel ; Logan, Amanda ; Layman, Rachel ; Ramaswamy, Bhuvaneswari ; Wesolowski, Robert ; Berger, Michael ; Patterson, Elaine ; Loprinzi, Charles Lawrence ; Shapiro, Charles L. ; Yee, Lisa. / Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain. In: Breast Cancer Research and Treatment. 2017 ; pp. 1-10.
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abstract = "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.",
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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 Lawrence

AU - Shapiro, Charles L.

AU - Yee, Lisa

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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.

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