Saliva substitute mouthwash in nasopharyngeal cancer survivors with xerostomia: a randomized controlled trial

Mohd Shawal Firdaus Mohamad,Kong Min Han,Dayaabaran Marimuthu,Mawaddah Azman

doi:10.1007/s00784-020-03634-5

Abstract

ObjectivesXerostomia is a prevalent sequelae among nasopharyngeal cancer (NPC) survivors; yet, effective treatment protocols have been elusive. This study was a prospective randomized clinical trial to compare the effects of saliva substitute mouthwash in nasopharyngeal cancer survivors with xerostomia, between two treatment arms, conducted in a tertiary center.Materials and methodsThis study measured the effects within 4 weeks in relation to summated xerostomia inventory (SXI) and unstimulated whole saliva (UWS). Patients randomized into the interventional arm were prescribed an immunologically active saliva substitute (IASS), while patients in the control arm were prescribed a non-immunologically active mouthwash as placebo.ResultsThe study population consisted of 94 patients. There was a significant difference in SXI difference (p < 0.0001) and UWS difference (p < 0.0001) between control and interventional arms. No harmful side effects associated with the use of either mouthwash encountered throughout the study duration.ConclusionIASS mouthwash significantly reduces subjective xerostomia scores measured using SXI and improves objective measurement of salivary flow using UWS among nasopharyngeal cancer survivors with xerostomia.Clinical relevanceIASS is significantly more effective in improving subjective and objective xerostomia measurements compared to non-immunologically active mouthwash. Additionally, this treatment is very safe, with superior side effect profiles.Trial registrationClinicalTrials.gov Identifier: NCT04491435

Highlights

Nasopharyngeal carcinoma (NPC) is the highest reported otorhinolaryngological malignancy in Malaysia affecting predominantly male adults between 40 and 60 years old [1, 2]
The efficacy of the saliva substitute Oral7® mouthwash was evaluated in a prospective, double-blind, randomized, placebo-controlled study that was conducted in the Department of Otorhinolaryngology, Universiti Kebangsaan Malaysia Medical Centre, a tertiary referral center between June 1, 2018 and January 2, 2020 for a duration of 19 months
All consecutive patients diagnosed with nasopharyngeal carcinoma during the study period who underwent either radiotherapy or concurrent chemo-radiotherapy were screened for the study

Summary

Introduction

Nasopharyngeal carcinoma (NPC) is the highest reported otorhinolaryngological malignancy in Malaysia affecting predominantly male adults between 40 and 60 years old [1, 2]. Xerostomia, or dry mouth caused by reduced or absent saliva flow, is a subjective symptom that can lead to impaired chewing, swallowing, altered sense of taste, and speech. This eventually affects their nutritional status and quality of life. The reported prevalence of xerostomia in NPC survivors ranged from 80 to 100% [6,7,8,9,10] This high prevalence has stemmed a lot of interest in prevention and treatment of this important sequelae. Palliative treatments such as mucosal lubricants, saliva substitute, saliva stimulants, and systemic or local sialogogues have been proposed [11,12,13]

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Conclusion