Study on a novel medical device for the treatment of reduced salivation (dry mouth) resulting from radiation therapy

INTERVENTION: Assuming that 20% of the patients of the control group report the successful outcome (30%+ reduction in symptoms on the VAS) and 60% of patients on the active device will do so, the sample size required to detect such a difference in reduction of xerostomia symptoms with 90% power using a cutoff for statistical significance of p<0.05 is 70. Considering a potential drop out of 20%, the total number of patients to be enrolled is 84 (42 in the study group and 42 in the control group). Salivary electrostimulation, Participants will be provided with a electrosimulating device to be applied in the mouth and used as symptoms dictate (max 10min/hour). Participants in the control group will receive a non‐active device.; Follow Up Length: 12 month(s); Study Entry : Registration and One or More Randomisations CONDITION: Topic: National Cancer Research Network, Oral and Gastrointestinal; Subtopic: Head and Neck Cancer, Oral and Gastrointestinal (all Subtopics); Disease: Head and Neck, Oral & Dental ; Digestive System ; Xerostomia PRIMARY OUTCOME: VAS dry mouth score; Timepoint(s): Month 0 and 12 as part of follow‐up appointments SECONDARY OUTCOME: 1.Home diary; Timepoint(s): To record fequency of device application and weekly VAS dry mouth score; 2. Quality of Life Measures; Timepoint(s): QoL questionnaires. Month 0, 1, 2, 4, 6, 8, 12 as part of follow up appointments; 3. Salivary flow measurement; Timepoint(s): During month 0, 1, 2, 4, 6, 8, 12 of the trial as part of follow‐up appointments INCLUSION CRITERIA: 1. To be at least 18 years old 2. To have received more than 40 Gy of external beam radiotherapy (RT) for cancer in the head and neck region at least 4 months before entry into the study 3. To have grade 1 or 2 of Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema 4. To have a degree of minimum degree of dryness of 50mm (=50mm) on a 100mm Visual Analogue Scale (VAS) scale (0=no dryness; 100=maximum dryness) 5. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax) 6. To have at least one parotid gland; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified