Title: A salivary pacemaker in the treatment of radiation-induced xerostomia: a double-blind randomised controlled trial of a novel neuro-electrostimulator of salivary glands
Funder: Department of Health (England)

Abstract: Background Head and neck (H&N) cancer is the 6th most common cancer worldwide. The majority of patients with H&N cancer are treated with surgery and radiotherapy (RT), with prolonged xerostomia being a common complication due to irrepairable damage to the salivary glands. Persistent moderate/severe RT-induced xerostomia affects 60% of long-term survivors who refer to it as the most debilitating effect of treatment. It impairs mastication, speech and taste and has a significant emotional impact causing depression and social isolation. Current strategies to prevent and treat RT-induced xerostomia are burdened by toxicity, high cost, low efficacy, contraindications and adverse side effects. Hence, there exists a significant unmet need for a treatment of xerostomia that is effective, convenient and safe. Aims This study will evaluate the benefit of a novel second-generation electro-stimulating intra-oral removable device in the management of dry mouth/salivary hypofunction induced by H&N radiotherapy. The study will comprise a randomized controlled double-blind trial of 12 months of therapy. Subjective (VAS dry mouth score and validated dry mouth questionnaire) and objective (salivary flow) tools will be used as primary and secondary outcomes measures before, during and after the trial. In addition Oral Health-related Quality of Life, as well as general Health-related Quality of Life, will be evaluated before and after the intervention using validated questionnaires. Sample size calculation (90% power, p Plan of Investigation The study will last 36 months and consist of the following parts: (i) Recruitment, randomization and construction/delivery of individualized devices (months 1 to 22). (ii) 12 month clinical trial (month 3 to 34). Patients will be randomly assigned to electrical or tactile stimulation (e.g. wearing a device without electric stimuli). Cases and controls will be allowed to use their routine local dry mouth therapy. Participants will be provided with a diary to record the number of applications/day and the degree of dryness/week. Participants will attend 10 clinical appointments of 30 minutes each for sialometry study and dry mouth/QOL questionnaires. 84 individuals will be enrolled (70 + 14 to consider 20% drop out). (iii) Final assessment, study closure and data analysis (months 35-36). Potential Impact Individuals with dry mouth have expressed a wish for a functional and non-pharmacological (“natural”) therapy which can improve natural salivation, is easy to administer, reliable and free of adverse side-effects. The use of the proposed intra-oral electrostimulating device has the potential to satisfy these requirements and reduce the costs of treatment to the NHS. If the trial is successful, the use of the device will lead to (i) an increase in natural salivation and consequent improvement in patient quality of life, (ii) reduction of cost of overall treatment [the current average cost of therapy is about £1,000-1,300/year per patient, whereas the cost of the device is £200-300].


Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL