Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia.
BACKGROUND
The authors undertook a multiinstitutional Phase II cooperative group study to examine the potential of oral fish oil fatty acid supplements administered at high doses to slow weight loss and to improve quality of life in patients with malignancy-related cachexia.


METHODS
Patients with advanced malignancy and weight loss > or = 2% of body weight in the preceding month took concentrated, high-dose omega-3 fatty acid capsules (7.5 g eicosapentaenoic acid plus docosahexaenoic acid for a 70 kg individual) that were supplied by the National Institutes of Health.


RESULTS
Forty-three patients with moderate or severe malnutrition were enrolled. The median time receiving treatment was 1.2 months. For the 36 patients who took at least 1 capsule and did not have edema, there was a weight change ranging from -6.2 kg to +3.5 kg and an overall median weight loss of 0.8 kg. Twenty-four patients had weight stabilization (a gain of < or = 5% or a loss of < 5%), 6 patients gained > 5% of their body weight, and 6 patients lost > or = 5% of their body weight. There was marked variability in the tolerability of the capsules, and many patients had gastrointestinal side effects. There was a correlation between time receiving treatment and weight gain for the 22 patients who were able to tolerate the capsules for at least 1 month. Quality-of-life scores were superior for patients who gained weight.


CONCLUSIONS
A majority of patients did not gain weight, and in that sense, the results of the study were unfavorable. However, a small but definite subset of patients had weight stabilization or weight gain. This suggests that omega-3 fatty acids have potential utility at the study doses, which were more than twice the doses used in published Phase III studies.
Burns
C Patrick
CP
Department of Internal Medicine, The University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa 52242, USA. c-burns@uiowa.edu
Halabi
Susan
S
Clamon
Gerald
G
Kaplan
Ellen
E
Hohl
Raymond J
RJ
Atkins
James N
JN
Schwartz
Michael A
MA
Wagner
Brett A
BA
Paskett
Electra
E
D000328:Adult; D000368:Aged; D002100:Cachexia / Q000178:diet therapy*; D002214:Capsules; D019587:Dietary Supplements / Q000009:adverse effects; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000178:diet therapy; D011228:Prealbumin / Q000378:metabolism; D011788:Quality of Life; D015430:Weight Gain
D002214:Capsules; D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D011228:Prealbumin