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

Abstract

To evaluate a pilocarpine spray as a treatment for xerostomia in patients treated with radiotherapy (RT) for head and neck cancer (HNC). 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 three times a day for 3months. After 1-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, 1hr (only SWSF), and at 1, 2, and 3months of treatment. Posttreatment SWFS was not statistically different between pilocarpine and placebo regardless of the treatment sequence (paired T test; p>.05), except for the SWFS rates at 2months after therapy. When comparing pilocarpine with placebo in the time points, there was no significant difference (p>.05) for QoL or XI. Significant differences in improvement in QoL and xerostomia experience appeared along time for pilocarpine group. The topical application of pilocarpine spray tested was similar to placebo on SWSF assessments in patients treated with RT for HNC.