Division of Radiation Oncology, Department of Radiation Oncology.
Faculty of Medicine, College of Medicine.
Am J Clin Nutr. 2019 Mar 1;109(3):606-614. doi: 10.1093/ajcn/nqy329.
Glutamine is the primary fuel for the gastrointestinal epithelium and maintains the mucosal structure. Oncologists frequently encounter oral mucositis, which can cause unplanned breaks in radiotherapy (RT).
The aim of this study was to explore the association between oral glutamine and acute toxicities in patients with head and neck cancer undergoing RT.
This was a parallel, double-blind, randomized, placebo-controlled Phase III trial conducted in a university hospital. A central randomization center used computer-generated tables to allocate interventions to 71 patients with stages I-IV head and neck cancers. The patients, care providers, and investigators were blinded to the group assignment. Eligible patients received either oral glutamine (5 g glutamine and 10 g maltodextrin) or placebo (15 g maltodextrin) 3 times daily from 7 d before RT to 14 d after RT. The primary and secondary endpoints were radiation-induced oral mucositis and neck dermatitis, respectively. These were documented in agreement with the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.
The study included 64 patients (placebo n = 33; glutamine n = 31) who completed RT for the completers' analysis. Based on multivariate analysis, glutamine had no significant effect on the severity of oral mucositis (OR: 0.3; 95% CI: 0.05, 1.67; P = 0.169). Only the change in body mass index (BMI) was significant in both multivariate completers (OR: 0.41; 95% CI: 0.20, 0.84; P = 0.015) and per-protocol analysis (OR: 0.40; 95% CI: 0.20, 0.83; P = 0.014). No difference was found in the incidence and severity of neck dermatitis between the two arms.
The decrease in BMI was strongly related to the severity of oral mucositis in the head and neck cancer patients under RT, but not to the use of glutamine. This trial was registered at clinicaltrials.gov as NCT03015077.
谷氨酰胺是胃肠道上皮细胞的主要燃料，可维持黏膜结构。肿瘤学家经常会遇到口腔黏膜炎，这可能导致放疗（RT）计划外中断。
本研究旨在探讨头颈部癌症患者接受 RT 期间口腔谷氨酰胺与急性毒性之间的关系。
这是一项在一所大学医院进行的平行、双盲、随机、安慰剂对照 III 期试验。中央随机分组中心使用计算机生成的表格将干预措施分配给 71 例 I-IV 期头颈部癌症患者。患者、护理提供者和研究者均对分组情况不知情。符合条件的患者在 RT 前 7 d 至 RT 后 14 d 期间每天接受 3 次口服谷氨酰胺（5 g 谷氨酰胺和 10 g 麦芽糊精）或安慰剂（15 g 麦芽糊精）治疗。主要和次要终点分别为放射性口腔黏膜炎和颈部皮炎。这些终点均按照美国国立癌症研究所不良事件通用术语标准第 3 版进行评估。
本研究纳入了 64 例（安慰剂组 n=33；谷氨酰胺组 n=31）完成 RT 的患者进行完全分析。基于多变量分析，谷氨酰胺对口腔黏膜炎的严重程度无显著影响（OR：0.3；95%CI：0.05，1.67；P=0.169）。仅在多变量完全分析（OR：0.41；95%CI：0.20，0.84；P=0.015）和意向性治疗分析（OR：0.40；95%CI：0.20，0.83；P=0.014）中，体重指数（BMI）的变化才有统计学意义。两组之间颈部皮炎的发生率和严重程度无差异。
在接受 RT 的头颈部癌症患者中，BMI 的下降与口腔黏膜炎的严重程度密切相关，但与谷氨酰胺的使用无关。本试验在 clinicaltrials.gov 注册，编号为 NCT03015077。
