Double-blind randomized study of oral glutamine on the management of radio/chemotherapy-induced mucositis and dermatitis in head and neck cancer.

This randomized clinical trial was designed to determine whether glutamine administration was effective in reducing the incidence and severity of mucositis and dermatitis induced by radiotherapy (RT) or chemoradiotherapy (CHRT) in patients with head and neck cancer (HNC). Fifty patients were randomized to receive orally either L-Glutamine or placebo (25 patients in each arm). In the glutamine-treated group, 10 g of oral glutamine was administered three times daily. The primary endpoint was to compare the appearance of clinical mucositis between groups at the 6th week, according to the Common Terminology Criteria for Adverse Events. Secondary endpoints were: Functional mucositis, mucositis onset, cervicofacial dermatitis, pain, weight loss and assessment of quality of life (according to the M.D. Anderson Symptom Inventory-Head and Neck). In total, 76 and 87.5% developed clinical mucositis in the glutamine and placebo group, respectively. The incidence and severity grade of mucositis at the 6th week did not exhibit statistically significantly differences between the two groups, although it had a higher value in the placebo group. Significant reduction of dermatitis incidence (P=0.038) and severity (P=0.032) was found in the glutamine group. There were no differences in other outcomes such as pain, weight loss and mucositis onset, in treatment parameters including concomitant chemotherapy, radiation dose and previous surgery, or in quality of life. The present study revealed that glutamine provided slight clinical effects compared with placebo in terms of reducing oral mucositis induced by RT or CHRT in patients with HNC at the 6th week; however, the results were not statistically significant. Although the findings suggested a significant benefit in reducing the incidence and severity of dermatitis, further confirmatory studies are required.