Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy

Kozelsky TF

Published in Journal of Clinical Oncology

Methodology

Phase III double-blind, placebo-controlled randomised trial of oral glutamine during pelvic radiation therapy, with NCI-graded acute diarrhoea as primary endpoint over the treatment course.

Key Findings

In 129 patients receiving pelvic radiotherapy, oral glutamine 4 g twice daily did not reduce the incidence or severity of acute radiation-induced diarrhoea compared with placebo, and diarrhoea severity was numerically slightly worse in the glutamine arm.

Conclusions

Oral glutamine does not prevent acute diarrhoea during pelvic radiotherapy and is not supported for this indication.

Limitations

Diarrhoea graded by clinician-reported toxicity criteria with limited sensitivity; single glutamine dose regimen tested; heterogeneous pelvic tumour sites and radiation fields; no assessment of late toxicity.