Randomized Multicenter Placebo-Controlled Trial of Omega-3 Fatty Acids for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain: SWOG S0927
Hershman DL, Unger JM, Crew KD, Awad D, Dakhil SR, Gralow J, Greenlee H, Lew DL, Minasian LM, Till C, Wade JL, Meyskens FL, Moinpour CM
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 75 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Breast Cancer Research Foundation
- Gobierno
- National Cancer Institute
- Gobierno
- NCI NIH HHS
- Subvenciones
- National Cancer Institute (U10CA180819); National Cancer Institute (1UG1CA189974-01); National Cancer Institute (UG1 CA189974)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2015-05-04 · J Clin Oncol · vol. 33 · número 17 · págs. 1910–1917
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 101 citas · más que el 96% de estudios similares · 4.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 44 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Cancer survivorship and care · Fatty Acid Research and Health · Cancer Treatment and Pharmacology
- Palabras clave
- omega-3 fatty acids, aromatase inhibitors, joint pain, musculoskeletal pain, breast cancer, early breast cancer, quality of life, triglycerides, lipid profile, C-reactive protein, endocrine therapy adverse effects
- MeSH
- musculoskeletal system, humans, breast neoplasms, arthralgia, fatty acids, omega-3, antineoplastic agents, aromatase inhibitors, neoplasm staging, treatment outcome, chemotherapy, adjuvant, drug administration schedule, double-blind method, postmenopause, quality of life, aged, middle aged, patient satisfaction, female, self report, musculoskeletal pain, surveys and questionnaires
13 autores
- Dawn L. Hershman🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Joseph M. Unger🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Katherine D. Crew🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Danielle Awad🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Shaker R. Dakhil🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Julie R. Gralow🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Heather Greenlee🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Danika L. Lew🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Lori M. Minasian🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Cathee Till🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- James Lloyd Wade🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Frank Louis Meyskens🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
- Carol M. Moinpour🇺🇸Columbia University Irving Medical Center; Fred Hutch Cancer Center; Cancer Center of Kansas; National Cancer Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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