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

Purpose: We performed this double-blinded, placebo-controlled study to determine the safety and efficacy of l-alanyl-l-glutamine in the prevention of mucositis in patients with head-and-neck cancer.

Methods and Materials: Thirty-two patients with head-and-neck cancer were treated with chemoradiotherapy (CRT) (radiotherapy daily up to 70 Gy plus cisplatin/5-fluoruracil once a week) and were asked to participate. Twenty-nine patients received the CRT schedule and were double-blindly assigned to receive either intravenous l-alanyl-l-glutamine 0.4 g/kg weight/day or an equal volume of saline (placebo) during chemotherapy days.

Results: Fourteen patients received l-alanyl-l-glutamine and 15 received placebo. Mucositis was assessed by the Objective Mucositis Score (OMS) and the World Health Organization (WHO) grading system. There was a significant difference in incidence of mucositis developed in patients receiving placebo compared with those who received l-alanyl-l-glutamine (p = 0.035). The number of patients with severe objective mucositis (OMS >1.49) was higher in the placebo group compared with the l-alanyl-l-glutamine group (67% vs. 14%, p = 0.007). l-alanyl-l-glutamine patients experienced less pain (three highest Numeric Rating Scale scores of 1.3/10 vs. 6.3/10 respectively, p = 0.008) and need for feeding tubes (14% vs. 60% respectively, p = 0.020) compared with placebo patients. No adverse effects related to the drug or the infusions were noted in either group.

Conclusion: For patients with head-and-neck cancer receiving CRT, intravenous l-alanyl-l-glutamine may be an effective preventive measure to decrease the severity of mucositis.

Keywords:  Mucositis , Glutamine , Head-and-neck cancer , Chemoradiation