A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum

Abstract

Background and purposeXerostomia is frequently reported after radiotherapy (RT) for head and neck cancer (HNC). The aim of this study was to reduce symptoms of radiation-induced xerostomia in HNC survivors, in which the experimental arm used chewing gum for a month. Primary endpoint was changes in scoring of dry mouth as defined by EORTC QLQ-H&N35 between arms. Materials and methodsParticipants with any grade of physician-assessed xerostomia, ≥ six month after RT, disease-free and able to chew gum were, for a month, randomized (2:1) to: (Arm A) daily chewing gum or (Arm B) standard care. Xerostomia-related QOL was assessed using EORTC QLQ-H&N35 and GRIX questionnaires along with measurement of salivary flow and viscosity at inclusion and after one month. The study was registered on ClinicalTrials.gov (NCT03302676). ResultsNinety-one participants were eligible for analysis (Arm A, n = 55; Arm B, n = 36). Comparing categorized scores for symptoms between arms, reduction of dry mouth was significantly higher for Arm A than Arm B (p = 0.05). A reduction in dry mouth scores was observed for xerostomia assessed by EORTC QLQ-H&N35 (question 41) for both arms. Salivary flow increased and viscosity decreased upon five minutes of stimulation within both arms (p < 0.001, respectively), however no significantly difference was observed between arms. ConclusionCategorized scores found reduction of dry mouth to be significantly higher in Arm A than Arm B, but no difference was seen for salivary flow rate and viscosity.