Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia
Fearon KC, Barber MD, Moses AG, Ahmedzai SH, Taylor GS, Tisdale MJ, Murray GD
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 190 citas
Etiquetas de revisión
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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 no declarada
Publicación
- Publicado
- 2006-07-18 · J Clin Oncol · vol. 24 · número 21 · págs. 3401–3407
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 281 citas · más que el 99% de estudios similares · 11.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 36 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Nutrition and Health in Aging · Clinical Nutrition and Gastroenterology · Fatty Acid Research and Health
- Palabras clave
- eicosapentaenoic acid, cancer cachexia, weight loss, lean body mass, advanced gastrointestinal cancer, lung cancer, omega-3 fatty acids, nutritional support
- MeSH
- humans, neoplasms, body weight, cachexia, eicosapentaenoic acid, body mass index, karnofsky performance status, analysis of variance, survival analysis, double-blind method, body composition, quality of life, adult, aged, middle aged, female, male, surveys and questionnaires
7 autores
- Kenneth C.H. Fearon🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
- Matthew D Barber🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
- Alastair G.W. Moses🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
- Sam Hjelmeland Ahmedzai🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
- Gillian S. Taylor🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
- Michael John Tisdale🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
- Gordon D. Murray🇬🇧Aston University; Royal Hallamshire Hospital; Edinburgh Royal Infirmary; University of Sheffield; University of Edinburgh
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
Eicosapentaenoic acid (EPA) has been proposed to have specific anticachectic effects. This trial compared EPA diethyl ester with placebo in cachectic cancer patients for effects on weight and lean body mass.
Patients and methods
Five hundred eighteen weight-losing patients with advanced gastrointestinal or lung cancer were studied in a multicenter, double-blind, placebo controlled trial. Patients were randomly assigned to receive a novel preparation of pure EPA at a dose of 2 g or 4 g daily or placebo (2g EPA, n = 175; 4 g EPA, n = 172; placebo, n = 171). Patients were assessed at 4 weeks and 8 weeks.
Results
The groups were well balanced at baseline. Mean weight loss at baseline was 18% (n = 518). Over the 8-week treatment period, both intention-to-treat analysis and per protocol analysis revealed no statistically significant improvements in survival, weight, or other nutritional variables. There was, however, a trend in favor of EPA with analysis of the primary end point, weight, at 8 weeks showing a borderline, nonsignificant treatment effect (P = .066). Relative to placebo, mean weight increased by 1.2 kg with 2 g EPA (95% CI, 0 kg to 2.3 kg) and by 0.3 kg with 4 g EPA (-0.9 kg to 1.5 kg).
Conclusion
The results indicate no statistically significant benefit from single agent EPA in the treatment of cancer cachexia. Future studies should concentrate on other agents or combination regimens.
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