Objective: The purpose of this study was to determine the most appropriate dose of oral glutamine to use in a further clinical study in paediatric oncology patients. Design: This was a phase I, pharmokinetic study. Setting: The study was carried out at The Yorkshire Regional Centre for Paediatric Oncology and Haematology, St James's University Hospital, Leeds, UK. Subjects: Thirteen patients undergoing treatment for paediatric malignancy participated in this study. All 13 completed the study. Interventions: The most appropriate dose was determined by patient acceptability and by plasma glutamine and ammonia levels measured at timed intervals after ingestion of a single glutamine dose. Results: Doses of 0.35, 0.5 and 0.65 g=kg were well tolerated with no untoward plasma glutamine and ammonia levels. One patient was recruited to a higher dose of 0.75 g=kg, but the plasma glutamine and ammonia levels peaked at 2601 and 155 mmol=l, respectively. The ammonia level was greater than the acceptable upper limit. It was difficult to disperse the glutamine adequately at this dose, resulting in the suspension being found to be unpalatable and therefore no further patients were recruited at this dose. Conclusion: It was concluded that 0.65 g=kg is a safe dose of glutamine to use in a clinical study in paediatric oncology patients. Sponsorship: Scientific Hospital Supplies UK Ltd provided the L-glutamine and financial help for the biochemical analysis.

Background/Objective: The study was conducted to determine if enteral glutamine, 0.65 g kg À1 daily for 7 days, is effective in reducing the incidence and severity of mucositis in paediatric oncology patients when given alongside chemotherapy. The study was carried out at St James's University Hospital, Leeds, UK. Subjects/Methods: This was a randomized study using the patients as their own controls. Seventy-six patients undergoing treatment for paediatric malignancy having at least two identical courses of chemotherapy and at risk of developing mucositis participated in the study. Patients received one course of chemotherapy with glutamine and an identical course without. Alternate patients were allocated to have glutamine with course 1 or with course 2. The severity of symptoms of mucositis and the duration of enteral and parenteral nutrition were recorded. Daily ammonia levels were measured. Results: Fifty patients completed the study. No statistical significance with regard to symptoms of mucositis was found. Fewer children receiving glutamine required parenteral nutrition (P ¼ 0.049), and the duration of parenteral nutrition was less (P ¼ 0.023). No adverse effects attributed to taking the glutamine were observed. Conclusions: The study showed that high-dose enteral glutamine did not reduce the incidence and severity of oral mucositis as determined by subjective toxicity measurements, but did show a significant reduction in parenteral nutrition usage. No adverse cumulative effect of this oral glutamine dose was observed.

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