The preventive role of intravenous L-alanyl L-glutamine in reducing the incidence of oral mucositis in head and neck cancer patients receiving radiotherapy with or without chemotherapy

Abstract

Background: The current prospective comparative phase 2 study aimed to assess the role of intravenous L-alanyl L-Glutamine in reducing the rate of oral mucositis for squamous head and neck cancer patients receiving radiotherapy with or without concurrent chemotherapy. Methods: From September 2014 to Septemper 2016, 100 head and neck cancer patients were treated with radiotherapy or combined chemo-radiation at the Clinical Oncology Department, Tanta University Hospitals. Patients were randomized in 1:1 ratio into Group A (n=50 patients) treated by radiotherapy or concurrent chemo-radiotherapy and Group B (n=50 patients) to receive same treatment in addition to intravenous Glutamine. The investigational drug was infused daily at dose of 0.3-0.4 g/kg diluted in NS and administered at rate of 0.1g/Kg/hr. All patients received total dose of 65-70 Gy using Linac 6MV photon beam supplemented with electron beam when needed. For concurrent chemotherapy, Cisplatin (40mg/m2) was administered weekly. Results: Mucositis was assessed byWHOgrading system. A significantly higher incidence of mucositis was reported in 45% of Group A patients compared with patients in group B who received glutamine 10% P<0.001). Group B patients had significantly longer period free from mucositis in comparison to group A with median time (12 weeks vs 8 weeks) P<0.001. A significant lower rate of radiotherapy interruption was reported in group B compared to group A (50% vs 15%) P<0.001. More Patients needed hospitalization in group A (20%) vs (5%) in group B P=0.059. No adverse effects were observed in relation to glutamine. Conclusions: Intravenous L-alanyl L-Glutamine may be an effective measure to lower incidence or prevention of oral mucositis in head and neck cancer patients treated by radiotherapy or combined chemo-radiation.