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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

From the Department of Clinical and Surgical Sciences (Surgery), Royal Infirmary; Public Health Sciences, Edinburgh University Medical School, Edinburgh; Academic Unit of Supportive Care, The University of Sheffield, Royal Hallamshire Hospital, Sheffield; and the Pharmaceuticals Sciences Institute, CRC Nutritional Biochemistry Research Group Aston University, Aston Triangle, Birmingham, United Kingdom

Address reprint requests to Kenneth C.H. Fearon, MD, Department of Clinical and Surgical Sciences (Surgery), The Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA United Kingdom; e-mail: k.fearon{at}ed.ac.uk

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.

Supported by Scotia Pharmaceuticals, United Kingdom.

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

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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