Cerchietti, L.C., Navigante, A.H., Lutteral, M.A., Castro, M.A., Kirchuck, R., Bonomi, M., … Uchima, P. (2006). Double-blinded, placebo-controlled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucositis following chemoradiotherapy in patients with head-and-neck cancer. International Journal of Radiation Oncology, Biology, Physics, 65, 1330–1337.doi: 10.1016/j.ijrobp.2006.03.042
Patients were randomized to receive IV L-alanyl-L-gluatime 0.3 g/kg (30 infusions in 5 patients) or 0.4 mg/kg (25 infusions in 5 patients), administered at a rate of 0.1 g/kg body weight/h. The principal endpoint was incidence of mucositis (mean of three highest scores by Objective Mucositis Assessment Score (OMAS) and highest grade on World Health Organization [WHO] scale).
The study used a two-step design. Patients were randomized first to different doses of the glutamine intervention, then to placebo (double-blind).
OMAS and WHO grading scale were used.
Measurement using both mucositis scales indicated a significant difference in intensity of mucositis.