1. Randomized double-blind, placebo-controlled trial evaluating oral glutamine on radiation-induced oral mucositis and dermatitis in head and neck cancer patients
- Author
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Chun-Ming Huang, Chih-Jen Huang, Kuei-Hau Luo, Yen-Yun Wang, Ming-Yii Huang, Frank Chen, Pen-Tzu Fang, Shyng-Shiou F. Yuan, Yu-Tsang Wang, Hung-Yi Chuang, Hsin-Hua Lee, and Chung-Ho Chen
- Subjects
Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Glutamine ,Placebo-controlled study ,Medicine (miscellaneous) ,Dermatitis ,Placebo ,Gastrointestinal epithelium ,BMI ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,Mucositis ,medicine ,Humans ,Radiation Injuries ,Adverse effect ,Aged ,Cancer ,Stomatitis ,030109 nutrition & dietetics ,Nutrition and Dietetics ,Radiotherapy ,business.industry ,Head and neck cancer ,Mouth Mucosa ,Common Terminology Criteria for Adverse Events ,Middle Aged ,medicine.disease ,Original Research Communications ,mucositis ,Head and Neck Neoplasms ,030220 oncology & carcinogenesis ,Female ,business - Abstract
Background 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). Objectives 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. Methods 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. Results 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. Conclusions 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.
- Published
- 2019