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.

Interventions for head and neck cancer survivors: Systematic review

“… 38 Receipt of cancer treatment, including radiation therapy (RT), surgery, or chemotherapy, was reported for most studies. Among the 28 studies, 17 included patients treated with radiation therapy with or without surgery/chemotherapy, 12 , 15 , 17 , 19 , 20 , 22 , 23 , 24 , 25 , 26 , 30 , 31 , 33 , 36 , 37 , 38 , 39 and 3 included patients treated with surgery with combinations of RT/chemotherapy 16 , 18 , 29 ; other studies included a combination of treatment modalities 28 , 35 , 40 or did not specify. 27 Hospital/academic setting was the site of patient recruitment and intervention training for all studies except for two that had a community‐based component of the intervention.…”

“…Most had a medium to high risk of bias. Among the 13 randomized studies, there were 12 with a medium 13 , 14 , 16 , 18 , 20 to high 12 , 15 , 17 , 19 , 21 , 22 , 23 risk of bias, and only one study with a low 24 risk of bias. The most common sources of bias were lack of concealment of allocation, heterogeneity of baseline participant characteristics, or unclear/lack of blinding of the participants, assessors, or those delivering the study intervention.…”

“…Most had a medium to high risk of bias. Among the 13 randomized studies, there were 12 with a medium 13,14,16,18,20 to high 12,15,17,19,[21][22][23] risk of bias, and only one study with a low 24 risk of bias.…”

“…24 Two studies had a medium risk of bias, and showed improvements in shoulder pain and function with a progressive resistance exercise training program, 18 and swallowing-related QOL measures after a guided self-help exercise program. 16 Four additional studies had a high risk of bias 12,17,22,23 focusing on appearance after submental liposuction, 12 dry mouth after chewing gum intervention, 17 trismus and dysphagia after speech and swallow rehabilitation exercise therapy, 22 and dry mouth with use of a hospital prepared saliva substitute. 23 The 13 non-randomized studies targeting physical effects of cancer therapy focused on improving trismus and dysphagia, 32,35,36,38,39 carotid stenosis surveillance, 33 prevention of dental complications and osteoradionecrosis, 25,37 cognitive function, 26 health-related quality of life after implant-retained dental prostheses into reconstructed mandibles, 29 and patient-reported physical symptoms and role functioning.…”

A nomogram for predicting late radiation-induced xerostomia among locoregionally advanced nasopharyngeal carcinoma in intensity modulated radiation therapy era

“…It takes approximately 2 years to recover after radiotherapy in most cases, which was confirmed by several patient self-reported questionnaires [ 6 ]. However, the majority of current studies focused on xerostomia less than 24 months [ 7 , 8 ]. Actually, it is more reliable and reasonable to focus on 24-months monitor to avoid confounding from the gradual recovery of parotid function.…”