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Oral glutamine in paediatric oncology patients: a dose finding study
1Dietetic Department, St James's University Hospital, Leeds, UK. paediatric_dietitian.sjuh@leeds.nhs.uk
Insights
This study determined the optimal oral glutamine dose for pediatric oncology patients. A dose of 0.65 g/kg was found to be safe and well-tolerated, establishing a suitable level for future clinical trials.
Area of Science:
- Pediatric Oncology
- Clinical Pharmacology
- Nutritional Support
Background:
- Paediatric oncology patients often experience treatment-related toxicities.
- Glutamine supplementation is being explored as a supportive therapy to mitigate these side effects.
- Determining an appropriate and safe dosage is crucial before large-scale clinical trials.
Purpose of the Study:
- To establish the optimal oral glutamine dose for paediatric oncology patients.
- To assess patient tolerability and safety at various glutamine dosages.
- To inform the design of future clinical studies investigating glutamine's efficacy.
Main Methods:
- Phase I pharmacokinetic study involving 13 paediatric oncology patients.
- Administration of single oral glutamine doses at 0.35, 0.5, 0.65, and 0.75 g/kg.
- Monitoring of plasma glutamine and ammonia levels, alongside patient acceptability assessments.
Main Results:
- Doses of 0.35, 0.5, and 0.65 g/kg were well-tolerated with no adverse effects on plasma glutamine or ammonia levels.
- A dose of 0.75 g/kg led to excessive ammonia levels and palatability issues, preventing further recruitment at this level.
- The 0.65 g/kg dose demonstrated good patient acceptability and safe pharmacokinetic profiles.
Conclusions:
- The recommended safe and well-tolerated oral glutamine dose for paediatric oncology patients is 0.65 g/kg.
- This dose is suitable for use in subsequent clinical studies.
- Further research can now proceed with a well-defined glutamine dosage regimen.
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 micro mol/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.
