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

BACKGROUND AND PURPOSE: Xerostomia 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 METHODS: Participants 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). RESULTS: Ninety-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. CONCLUSION: Categorized 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.

Reducing Late Dysphagia for Head and Neck Cancer Survivors with Oral Gel: A Feasibility Study.

Dysphagia is a significant late morbidity following treatment with radiotherapy (RT) for head and neck squamous cell carcinomas (HNSCC). The purpose of this feasibility study was to test a gel-based saliva substitute to reduce the subjective assessment of dysphagia while eating food items varying in size and texture. Eligible study subjects treated with curative intended RT and suffering from dysphagia and xerostomia were recruited from the outpatient clinic during a two-month period. Nineteen subjects consented to participation and completed the EORTC QLQ-H&N35 questionnaire and three test meals. A Numeric Rating Scale (NRS) was used for subjective assessment of dysphagia during all test meals. All data on patient, tumor, and treatment characteristics were obtained from the Danish Head and Neck Cancer (DAHANCA) database. NRS data suggested reduction of dysphagia after application of the oral gel. The swallowing dysfunctions, discomfort while swallowing (p = 0.008), stuck food items (p = 0.02), and multiple attempts of clearing the throat (p = 0.05), improved significantly for soft and regular items. Both small- and large-sized food items were tested. EORTC QLQ-H&N35 showed improvement regarding eating problems (p = 0.03) and social eating (p = 0.02). No episodes of food aspiration were recorded during the test meals. Late dysphagia reduces QOL and is an important morbidity following RT. In this feasibility study, the oral gel was able to reduce dysphagia while eating soft and selected regular food items. Eating-related EORTC QLQ-H&N35 items also improved, indicating a beneficial reduction in dysphagia after application of the oral gel.

Xerostomia after Radiotherapy for Oral and Oropharyngeal Cancer: Increasing Salivary Flow with Tasteless Sugar-free Chewing Gum.

INTRODUCTION: Radiation-induced xerostomia is a frequent late side effect after treatment for oral and oropharyngeal cancers. This may induce swallowing difficulties, compromised oral well-being, reduced nutrition intake, or speech deficiencies. Consequently, quality of life is often impaired for these patients. OBJECTIVES: The purpose of this study was to investigate the possibility to mechanically stimulate residual saliva function by using tasteless and sugar-free chewing gum. It was hypothesized that tasteless and sugar-free chewing gum could immediately increase salivary flow and potentially improve oral well-being when used on a regular basis. METHODS: From October to December 2014, 31 consecutive patients treated with primary radiotherapy (RT) and concomitant cisplatin (in locally advanced cases) for oral or oropharyngeal cancer consented to participate. All patients had finalized RT 2-8 months prior to participation and suffered from xerostomia. Samples of unstimulated and chewing gum-stimulated saliva were obtained at the entry into the study (Visit 1). For 2 weeks, patients used chewing gum on a regular basis whereupon saliva measurements were repeated to verify the changes (Visit 2). An abbreviated EORTC H&N35 questionnaire was completed for both visits. A small control group consisting of young and healthy individuals also tested the chewing gum. RESULTS: Twenty patients completed the study and an increase in saliva flow was observed for 14 patients. Before and after intervention with chewing gum, an increase in mean saliva output was seen between unstimulated and stimulated saliva for both Visit 1 and 2 (p = 0.008 and p = 0.05, respectively). No change in saliva output was seen in the control group. CONCLUSION: The chewing gum was able to stimulate saliva output that was seen at the beginning and at the end of the intervention. No improvement in baseline saliva was seen. Relevant changes in subjective measures of xerostomia were seen after 2 weeks of chewing the gum.