Ensaio clínico randomizado fase III da eficácia do betanecol no tratamento da xerostomia em pacientes com neoplasias malignas das vias aerodigestivas superiores submetidos à radioterapia

Abstract

The aim of this study was to verify whether the use of bethanechol during radiotherapy (RT) for head and neck cancer (HNC) prevents radiation-induced xerostomia and reduced salivary flow. Patients that would begin RT were randomly allocated into bethanechol (group 1) or artificial saliva (group 2). The drug was administered during the course of radiotherapy. Whole resting saliva (WRS) and whole stimulated saliva (WSS) were collected from all the patients at the following four stages: baseline, during, immediately after, and at least two months after the end of RT. Each time saliva was collected, xerostomia was assessed by a subjective visual analogue scale (VAS). In addition, patients answered whether they felt or not their mouth dry. A total of 43 patients was randomized into this clinical trial. Age, gender, tumor site, tumor stage, treatment plan, RT equipment and RT field were similarly distributed among groups. WRS immediately after RT was significantly higher in group 1 (p=0.03). The remaining measurements of salivary flows were always higher in group 1, but without statistical significance. In general, VAS values were lower and xerostomia complaint was less common in group 1, once again without statistical significance. The use of bethanechol during RT for HNC cancer was associated with significantly higher WRS immediately after RT in comparison to a similar cohort of patients who had not received bethanechol.