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An Eicosapentaenoic Acid Supplement Versus Megestrol Acetate Versus Both for Patients With Cancer-Associated Wasting: A North Central Cancer Treatment Group and National Cancer Institute of Canada Collaborative Effort

From the Mayo Clinic and Foundation, Rochester; Duluth Community Clinical Oncology Program, Duluth, MN; Carle Cancer Center Community Clinical Oncology Program, Urbana, IL; Cancer Center of Kansas—Medical Arts Tower, Wichita, KS; Missouri Valley Cancer Consortium, Omaha, NE; Geisinger Clinic & Medical Center Community Clinical Oncology Program, Danville, PA; and McGill University, Montreal, Canada

Address reprint requests to Aminah Jatoi, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: jatoi.aminah{at}mayo.edu

PURPOSE: Studies suggest eicosapentaenoic acid (EPA), an omega-3 fatty acid, augments weight, appetite, and survival in cancer-associated wasting. This study determined whether an EPA supplement—administered alone or with megestrol acetate (MA)—was more effective than MA.

PATIENTS AND METHODS: Four hundred twenty-one assessable patients with cancer-associated wasting were randomly assigned to an EPA supplement 1.09 g administered bid plus placebo; MA liquid suspension 600 mg/d plus an isocaloric, isonitrogenous supplement administered twice a day; or both. Eligible patients reported a 5-lb, 2-month weight loss and/or intake of less than 20 calories/kg/d.

RESULTS: A smaller percentage taking the EPA supplement gained 10% of baseline weight compared with those taking MA: 6% v 18%, respectively (P = .004). Combination therapy resulted in weight gain of 10% in 11% of patients (P = .17 across all arms). The percentage of patients with appetite improvement (North Central Cancer Treatment Group Questionnaire) was not statistically different: 63%, 69%, and 66%, in EPA-, MA-, and combination-treated arms, respectively (P = .69). In contrast, 4-week Functional Assessment of Anorexia/Cachexia Therapy scores suggested MA-containing arms experienced superior appetite stimulation compared with the EPA arm, with scores of 40, 55, and 55 in EPA-, MA-, and combination-treated arms, respectively (P = .004). Survival was not significantly different among arms. Global quality of life was not significantly different among groups. With the exception of increased impotence in MA-treated patients, toxicity was comparable.

CONCLUSION: This EPA supplement, either alone or in combination with MA, does not improve weight or appetite better than MA alone.

Conducted as a collaborative trial of the North Central Cancer Group, Mayo Clinic, and the National Cancer Institute of Canada, and supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-63826, CA-63849, CA-35269, CA-35448, CA-35195, CA-35113, CA-60276, CA-52352, CA-35101, CA-35103, CA-63848, CA-35272, and CA-37417.

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

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