Chih-Jen Huang1,2, Ming-Yii Huang1,2, Pen-Tzu Fang1, Frank Chen1, Yu-Tsang Wang3, Chung-Ho Chen4, Shyng-Shiou Yuan3, Chun-Ming Huang1,2, Kuei-Hau Luo5, Hung-Yi Chuang5,6, Yen-Yun Wang3, Hsin-Hua Lee1,7. 1. Division of Radiation Oncology, Department of Radiation Oncology. 2. Faculty of Medicine, College of Medicine. 3. Department of Medical Research. 4. Faculty of Dental Hygiene. 5. Department of Occupational and Environmental Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 6. Faculty of Department of Public Health, College of Health Science, Kaohsiung Medical University, Kaohsiung, Taiwan. 7. PhD Program in Environmental and Occupational Medicine, Kaohsiung Medical University and National Health Research Institutes, Kaohsiung, Taiwan.
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.
RCT Entities:
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 cancerpatients under RT, but not to the use of glutamine. This trial was registered at clinicaltrials.gov as NCT03015077.
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