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 journalArticle

Abstract

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
Volume24
Issue number21
DOIs
Publication statusPublished - Jul 2006

Fingerprint

Cachexia
Eicosapentaenoic Acid
Placebos
Neoplasms
Weights and Measures
eicosapentaenoic acid diester
Intention to Treat Analysis
Gastrointestinal Neoplasms
Weight Loss
Lung Neoplasms
Esters
Therapeutics
Body Weight
Survival

Bibliographical note

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

Keywords

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

Cite this

Fearon, K. C. H., Barber, M. D., Moses, A. G., Ahmedzai, S. H., Taylor, G. S., Tisdale, M. J., & Murray, G. D. (2006). Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia. Journal of clinical oncology, 24(21), 3401-3407. https://doi.org/10.1200/JCO.2005.04.5724
Fearon, Kenneth C.H. ; Barber, Matthew D. ; Moses, Alastair G. ; Ahmedzai, Sam H. ; Taylor, Gillian S. ; Tisdale, Michael J. ; Murray, Gordon D. / Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia. In: Journal of clinical oncology. 2006 ; Vol. 24, No. 21. pp. 3401-3407.
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Fearon, KCH, Barber, MD, Moses, AG, Ahmedzai, SH, Taylor, GS, Tisdale, MJ & Murray, GD 2006, 'Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia', Journal of clinical oncology, vol. 24, no. 21, pp. 3401-3407. https://doi.org/10.1200/JCO.2005.04.5724

Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia. / Fearon, Kenneth C.H.; Barber, Matthew D.; Moses, Alastair G.; Ahmedzai, Sam H.; Taylor, Gillian S.; Tisdale, Michael J.; Murray, Gordon D.

In: Journal of clinical oncology, Vol. 24, No. 21, 07.2006, p. 3401-3407.

Research output: Contribution to journalArticle

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T1 - Double-blind, placebo-controlled, randomized study of eicosapentaenoic acid diester in patients with cancer cachexia

AU - Fearon, Kenneth C.H.

AU - Barber, Matthew D.

AU - Moses, Alastair G.

AU - Ahmedzai, Sam H.

AU - Taylor, Gillian S.

AU - Tisdale, Michael J.

AU - Murray, Gordon D.

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PY - 2006/7

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N2 - 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.

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