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


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).


CONCLUSIONS
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.
Fearon
Kenneth C H
KC
Department of Clinical and Surgical Sciences (Surgery), The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom. k.fearon@ed.ac.uk
Barber
Matthew D
MD
Moses
Alastair G
AG
Ahmedzai
Sam H
SH
Taylor
Gillian S
GS
Tisdale
Michael J
MJ
Murray
Gordon D
GD
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001823:Body Composition; D015992:Body Mass Index; D001835:Body Weight; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis
C419487:eicosapentaenoic acid diester; D015118:Eicosapentaenoic Acid