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Phase I Clinical Study of Fish Oil Fatty Acid Capsules for Patients with Cancer Cachexia: Cancer and Leukemia Group B Study 9473¹

The University of Iowa Cancer Center, Iowa City, Iowa 52242 [C. P. B., G. H. C., B. A. W., R. J. H.]; CALGB Statistical Center, Durham, North Carolina 27710 [S. H., V. H.]; Lakeland Medical Center, St. Joseph, Michigan 49085 [E. L.]; Syracuse Hematology-Oncology Community Clinical Oncology Program, State University of New York Health Science Center at Syracuse, Syracuse, New York 13217 [J. J. K.]; North Shore University Hospital, Manhasset, New York 11030 [V. V.]; and Bowman Gray School of Medicine, Winston-Salem, North Carolina 27157 [E. P.]

The purpose of this study was to determine the maximum tolerated dose and dose-limiting toxicities of fish oil fatty acid capsules containing -3 fatty acid ethyl esters. Twenty-two patients with neoplastic disease not amenable to curative therapy who had lost 2% of body weight over a previous 1 month time period were given an escalating dose of fish oil fatty acids. The maximum tolerated dose was found to be 0.3 g/kg per day of this preparation. This means that a 70-kg patient can generally tolerate up to 21 1-g capsules/day containing 13.1 g of eicosapentaenoic acid + docosahexaenoic acid, the two major -3 fatty acids. Dose-limiting toxicity was gastrointestinal, mainly diarrhea, and a poorly described toxicity designated as "unable to tolerate in esophagus or stomach." A patient with chronic lymphocytic leukemia taking the fish oil provided an unusual opportunity to perform a detailed biochemical study of the effect of fish oil capsules on the lipids of malignant cells at several sequential time points in treatment. Studies of the malignant lymphocytes, serum, and whole blood of this one patient revealed an increase in eicosapentaenoic acid, the major component of the fish oil capsules, during fish oil capsule treatment. This study provides a scientific basis for the selection of -3 fatty acid doses for future studies in cancer. The maximum tolerated dose found is considerably higher than anticipated from published studies of many human diseases. The observation of a modification of the lipids of leukemic cells, serum, and blood in a patient with chronic leukemia provides a biochemical basis for a possible effect of fish oil supplements on cancer cachexia and tumor growth.

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