Oral glutamine in paediatric oncology patients: a dose finding study.
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.


METHODS
This was a phase I, pharmokinetic study.


METHODS
The study was carried out at The Yorkshire Regional Centre for Paediatric Oncology and Haematology, St James's University Hospital, Leeds, UK.


METHODS
Thirteen patients undergoing treatment for paediatric malignancy participated in this study. All 13 completed the study.


METHODS
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.


CONCLUSIONS
It was concluded that 0.65 g/kg is a safe dose of glutamine to use in a clinical study in paediatric oncology patients.
Ward
E
E
Dietetic Department, St James's University Hospital, Leeds, UK. paediatric_dietitian.sjuh@leeds.nhs.uk
Picton
S
S
Reid
U
U
Thomas
D
D
Gardener
C
C
Smith
M
M
Henderson
M
M
Holden
V
V
Kinsey
S
S
Lewis
I
I
Allgar
V
V
D000284:Administration, Oral; D000293:Adolescent; D000641:Ammonia / Q000097:blood*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D019540:Area Under Curve; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005973:Glutamine / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D006801:Humans; D007249:Inflammation / Q000139:chemically induced / Q000517:prevention & control; D007263:Infusions, Parenteral; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology; D007441:Intubation, Gastrointestinal; D008297:Male; D020714:Maximum Tolerated Dose; D008657:Metabolic Clearance Rate; D009369:Neoplasms / Q000188:drug therapy*; D012449:Safety
D005973:Glutamine; D000641:Ammonia