Clinical trial: prophylactic intravenous alanyl‐glutamine reduces the severity of gastrointestinal toxicity induced by chemotherapy – a randomized crossover study

Summary Background Glutamine has been shown in numerous studies to reduce intestinal permeability which can be increased by chemotherapy. However, there have been few reports that conduct on its clinical effect on gastrointestinal toxicity. Aim To examine whether prophylactic intravenous alanyl‐glutamine dipeptide can ameliorate clinical manifestations of gastrointestinal toxicity induced by chemotherapy. Methods Forty‐four patients with gastric or colorectal cancer developing WHO side‐effect grading system of grade 2 or higher were randomized to either control group ( n = 22) or Gln group ( n = 22) during next cycle of chemotherapy. Patients were crossed over to the alternate treatment during chemotherapy cycle 2. In the control group, the patients received the same chemotherapy regimens as screening cycle and in the Gln group, the patients received chemotherapy and alanyl‐glutamine. Prophylactic intravenous 20 g of alanyl‐glutamine dipeptide was given for 5 days. Results Compared with the control group, the plasma glutamine level in the Gln group was significantly higher and the plasma endotoxin level was significantly lower. The scores of nausea/vomiting and diarrhoea decreased significantly. Conclusion Prophylactic intravenous alanyl‐glutamine is effective in preventing intestinal permeability disruption induced by chemotherapy and clinical manifestations of gastrointestinal toxicity.