Raony Môlim de Sousa Pereira1, Mônica Danielle Ribeiro Bastos1, Maíra Peres Ferreira2, Osvaldo de Freitas2, Leandro Dorigan de Macedo3, Harley Francisco de Oliveira4, Hilton Marcos Alvez Ricz5, Ana Carolina Fragoso Motta6, Ana Paula Macedo1, Camila Tirapelli1, Vinicius Pedrazzi1. 1. Departament of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo, Brazil, Ribeirão Preto. 2. Department of Pharmaceutical Sciences, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Brazil, Ribeirão Preto. 3. Dentistry and Stomatology Division, Ribeirão Preto Clinical Hospital, Ribeirão Preto School of Medicine, University of São Paulo, Ribeirão Preto, SP, Brazil. 4. School of Medicine, University of São Paulo, Ribeirão Preto Clinical Hospital, Ribeirão Preto Ribeirão Preto, Ribeirão Preto, SP, Brazil. 5. Ophthalmology, Otolaryngology and Head and Neck Surgery Department, Otolaryngology and Head and Neck Surgery Department, Ribeirão Preto School of Medicine, University of São Paulo, Ribeirão Preto, São Paulo, Brazil. 6. Department of Stomatology, Public Health and Forensic Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.
Abstract
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. This article is protected by copyright. All rights reserved.
RCT Entities:
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. This article is protected by copyright. All rights reserved.
Entities:
Keywords:
Clinical trial; Head and neck cancer; Pilocarpine; Xerostomia. Quality of life. Radiotherapy