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J Clin Oncol. 2015 Jun 10;33(17):1910-7. doi: 10.1200/JCO.2014.59.5595. Epub 2015 May 4.

Randomized Multicenter Placebo-Controlled Trial of Omega-3 Fatty Acids for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain: SWOG S0927.

Author information

1
Dawn L. Hershman, Katherine D. Crew, Danielle Awad, and Heather Greenlee, Columbia University Medical Center, New York, NY; Joseph M. Unger, Danika L. Lew, and Cathee Till, Southwest Oncology Group Statistical Center; Joseph M. Unger, Julie Gralow, Danika L. Lew, Cathee Till, and Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; Lori M. Minasian, National Cancer Institute, Bethesda, MD; James L. Wade III, Central Illinois Community Clinical Oncology Program/Cancer Care Specialists of Central Illinois, Decatur, IL; and Frank L. Meyskens, University of California at Irvine, Chao Family Comprehensive Cancer Center, Orange, CA. dlh23@columbia.edu.
2
Dawn L. Hershman, Katherine D. Crew, Danielle Awad, and Heather Greenlee, Columbia University Medical Center, New York, NY; Joseph M. Unger, Danika L. Lew, and Cathee Till, Southwest Oncology Group Statistical Center; Joseph M. Unger, Julie Gralow, Danika L. Lew, Cathee Till, and Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Shaker R. Dakhil, Cancer Center of Kansas, Wichita, KS; Lori M. Minasian, National Cancer Institute, Bethesda, MD; James L. Wade III, Central Illinois Community Clinical Oncology Program/Cancer Care Specialists of Central Illinois, Decatur, IL; and Frank L. Meyskens, University of California at Irvine, Chao Family Comprehensive Cancer Center, Orange, CA.

Abstract

PURPOSE:

Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors (AIs) and can result in decreased quality of life and discontinuation of therapy. Omega-3 fatty acids (O3-FAs) can be effective in decreasing arthralgia resulting from rheumatologic conditions and reducing serum triglycerides.

PATIENTS AND METHODS:

Women with early-stage breast cancer receiving an AI who had a worst joint pain/stiffness score ≥ 5 of 10 using the Brief Pain Inventory-Short Form (BPI-SF) were randomly assigned to receive either O3-FAs 3.3 g or placebo (soybean/corn oil) daily for 24 weeks. Clinically significant change was defined as ≥ 2-point drop from baseline. Patients also completed quality-of-life (Functional Assessment of Cancer Therapy-Endocrine Symptoms) and additional pain/stiffness assessments at baseline and weeks 6, 12, and 24. Serial fasting blood was collected for lipid analysis.

RESULTS:

Among 262 patients registered, 249 were evaluable, with 122 women in the O3-FA arm and 127 in the placebo arm. Compared with baseline, the mean observed BPI-SF score decreased by 1.74 points at 12 weeks and 2.22 points at 24 weeks with O3-FAs and by 1.49 and 1.81 points, respectively, with placebo. In a linear regression adjusting for the baseline score, osteoarthritis, and taxane use, adjusted 12-week BPI-SF scores did not differ by arm (P = .58). Triglyceride levels decreased in patients receiving O3-FA treatment and remained the same for those receiving placebo (P = .01). No between-group differences were seen for HDL, LDL, or C-reactive protein.

CONCLUSION:

We found a substantial (> 50%) and sustained improvement in AI arthralgia for both O3-FAs and placebo but found no meaningful difference between the groups.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01385137.

PMID:
25940724
PMCID:
PMC4451174
DOI:
10.1200/JCO.2014.59.5595
[Indexed for MEDLINE]
Free PMC Article

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