Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial

Background: Oral mucositis is one of the painful, debilitating and common complications in the patients under chemotherapy for which no certain and effective treatment has not been considered. The aim of this pilot study was to evaluate the efficacy of phenytoin mucoadhesive tablets on treating oral mucositis compared with phenytoin mouthwash. Methods: In this clinical trial, after preparation and in vitro characterization of phenytoin mucoadhesive tablets, 27 patients were enrolled from oncology department of Nemazee Hospital, Shiraz, Iran. 21 patients with oral mucositis, who had the inclusion criteria due to chemotherapy, were divided into two groups of A (11 patients received phenytoin mouthwash 0.5%) and B (10 patients received phenytoin mucoadhesive tablet). Severity of oral mucositis (WHO grading), oral pain Visual Analogue Scale and the extension of lesions (number of involved sites) were assessed on three intervals (at the beginning and one or two weeks after beginning of the study). Results: In the first visit, there was no significant statistical difference between the two groups regarding mean age, mucositis severity and visual analogue scale. However, on first and second weeks after beginning of the study, mucositis severity, extension of lesion and visual analogue scale in both groups were significantly lower than onset of the treatment; however, no significant difference between the two groups was observed. Conclusions: Phenytoin mouthwash and mucoadhesive tablets used for oral mucositis care in patients after chemotherapy showed significant improvement in the lesions. Patients were more satisfied with mouthwash and all the patients in this group were free of lesion after two weeks