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

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ORIGINAL ARTICLE

Saliva substitute mouthwash in nasopharyngeal cancer survivors with xerostomia: a randomized controlled trial Dayaabaran Marimuthu 1 & Kong Min Han 1 & Mohd Shawal Firdaus Mohamad 2 & Mawaddah Azman 1 Received: 13 August 2020 / Accepted: 7 October 2020 # The Author(s) 2020

Abstract Objectives Xerostomia 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 methods This 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. Results The 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. Conclusion IASS 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 relevance IASS 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 registration ClinicalTrials.gov Identifier: NCT04491435 Keywords Xerostomia . Mouth dryness . Hyposalivation . Saliva artificial . Saliva substitute . Mouthwashes . Radiation-induced toxicity . Nasopharyngeal cancer

Introduction Nasopharyngeal carcinoma (NPC) is the highest reported otorhinolaryngological malignancy in Malaysia affecting predominantly male adults between 40 and 60 years old [1, 2]. Radiation therapy (RT) has been coined as the mainstay treatment owing to its’ radiosensitive properties [1, 3]. Radiationinduced DNA damage impairs proper cell division, resulting

* Mawaddah Azman [email protected] 1

Department of Otorhinolaryngology and Head and Neck Surgery, Level 9, Clinical Block, UKM Medical Centre, National University of Malaysia Kuala Lumpur Campus, Jalan Yaacob Latiff, Bandar Tun Razak, 56000 Kuala Lumpur, Malaysia

2

Centre of Studies for Oral and Maxillofacial Surgery, Faculty of Dentistry, UiTM Sungai Buloh Campus, Jalan Hospital, 47000 Sugai Buloh, Selangor, Malaysia

in cell death or senescence of cells that attempt to divide, particularly useful in killing malignant cells. However, radiation doses to the salivary glands cause loss of saliva producing acinar cells which ultimately hampers production of s