GLUTAMINE SUPPLEMENTATION IN CANCER-PATIENTS RECEIVING CHEMOTHERAPY -A DOUBLE-BLIND RANDOMIZED STUDY

The purpose of this study was to evaluate the efficacy of glutamine in preventing doxifluridine-induced diarrhea and the potential impact of glutamine an the tamer growth. We investigated 65 patients with advan ced breast cancer receiving doxifluridine in a double-blind randomized fashion: 33 patients took glutamine (30 g/d, divided in 3 doses of 10 g each) for 8 consecutive days (5-12th) during each interval between chemotherapy, which was administered from day 1 to 4. Thirty-two patie nts took an equal dose of placebo (maltodextrine). The incidence of di arrhea was registered after each cycle of chemotherapy and severity wa s scored by the National Cancer Institute (NCI), Bethesda, Maryland, c lassification. The tumor response was evaluated by the World Health Or ganization (WHO) criteria. A total of 278 and 259 cycles (median 10 cy cles), respectively, were delivered in glutamine and placebo groups. T here were 34 and 32 episodes of diarrhea in glutamine and placebo grou ps, with no statistical difference overall, in the severity and durati on of tumor growth, there was no difference in the response rate (21% and 28% of complete or partial response, respectively), in median time to response (2 mo), or in median duration of response. In conclusion, glutamine did not prevent the occurrence of the doxifluridine-induced diarrhea and did not have any impact on tumor response to chemotherap y. (C)Elsevier Science Inc. 1997.