Topical pilocarpine for xerostomia in patients with head and neck cancer treated with radiotherapy.

OBJECTIVE: To evaluate a pilocarpine spray as a treatment for xerostomia in patients treated with radiotherapy (RT) for head and neck cancer (HNC). METHODS: This was a placebo-controlled, double-blind, crossover clinical trial of patients complaining of dry mouth after RT for HNC. Forty patients were randomly assigned to either placebo or pilocarpine (1.54%) spray and instructed to use 3 times a day for three months. After one-month washout period, patients were crossed over to receive placebo or pilocarpine. The assessments were salivary flow (Stimulated Whole Saliva Flow-SWSF), xerostomia (Xerostomia Inventory - XI) and quality of life (QoL/Oral Health Impact Profile - OHIP-14), assessed at baseline, one hour (only SWSF), and at one, two and three months of treatment. RESULTS: Posttreatment SWFS was not statistically different between pilocarpine and placebo regardless of the treatment sequence (paired T test; p>0.05), except for the SWFS rates at two months after therapy. When comparing pilocarpine with placebo in the time points, there was no significant difference (p>0.05) for QoL or XI. Significant differences of improvement in QoL and xerostomia experience appeared along time for pilocarpine group. CONCLUSION: The topical application of pilocarpine spray tested was similar to placebo on SWSF assessments in patients treated with RT for HNC.