Interventions
xerostomia
XEROSTOMIA
A baseline visit (T0) was conducted 3 months after the end of RT. Demographic data and a thorough medical history were recorded with particular attention to oncologic history (i.e. chemotherapy, oncologic surgery, and RT dose) and smoking habits.The basal and stimulated salivary flow rates were measured, and patients were asked to complete the questionnaires to assess their xerostomia grade. The unstimulated salivary flow rate was assessed using the spitting method. Patients were instructed to collect their saliva for 5 min in a graded tube. The stimulated salivary flow was determined in a similar manner. Salivary secretion was stimulated by applying a solution of 2% citric acid to the sides of the tongue at intervals of 30 s [The investigational product sodium-hyaluronate mouthwash (HydralThe patients were divided into two groups: on day 1 (baseline—T0), after the questionnaires were answered, group A received the treatment product and group B received the placebo. On day 30, the administration of the products was stopped, and the questionnaires were administered together with the Likert scale. Following this, a 30-day washout phase was conducted, followed by Phase 2 of the study. On day 61, patients completed the questionnaires again, and each group was treated with the alternative product. On day 90, the final questionnaires were administered, and all endpoints were investigated. Each visit is described in the study flowchart (Fig. Consort flow diagram of the trial