Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia

Kenneth C.H. Fearon, Matthew D. Barber, Alastair G. Moses, Sam H. Ahmedzai, Gillian S. Taylor, Michael J. Tisdale, Gordon D. Murray

Research output: Contribution to journalArticlepeer-review


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 4g 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. © 2006 by American Society of Clinical Oncology.

Original languageEnglish
Pages (from-to)3401-3407
Number of pages7
JournalJournal of clinical oncology
Issue number21
Publication statusPublished - Jul 2006

Bibliographical note

Presented in part at the European Society of Parenteral and Enteral Nutrition in Brussels, Belgium 2005.


  • eicosapentaenoic acid
  • EPA
  • anticachectic effects
  • cachectic cancer
  • cancer cachexia


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