Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia A Cancer and Leukemia Group B study C. Patrick Burns, M.D. 1 2 *, Susan Halabi, Ph.D. 3, Gerald Clamon, M.D. 1 2, Ellen Kaplan, M.A. 3, Raymond J. Hohl, M.D., Ph.D. 1 2, James N. Atkins, M.D. 4, Michael A. Schwartz, M.D. 5, Brett A. Wagner, M.A. 1 2, Electra Paskett, Ph.D. 6 1Department of Internal Medicine, The University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa 2The University of Iowa Holden Comprehensive Cancer Center, Iowa City, Iowa 3Cancer and Leukemia Group B Statistical Center, Durham, North Carolina 4Southeast Cancer Control Consortium, Inc., Goldsboro, North Carolina 5Mount Sinai Medical Center, Miami, Florida 6School of Public Health, The Ohio State University, Columbus, Ohio email: C. Patrick Burns (c-burns@uiowa.edu) *Correspondence to C. Patrick Burns, Department of Medicine, The University of Iowa Carver College of Medicine, 200 Hawkins Dr., Iowa City, IA 52242 The views expressed herein are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. Fax: (319) 353-8383 Abstract 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 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 5% or a loss of < 5%), 6 patients gained > 5% of their body weight, and 6 patients lost 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. Cancer Volume 101, Issue 2 , Pages 370 - 378 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.