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

<strong>Background:</strong> 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 mucoadhe...

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Main Authors: Fahimeh Rezazadeh, Soleiman Mohammadi-Samani, Fatemeh Talei, Mani Ramzi, Hajar Ashrafi, Zahra Emami
Format: Article
Language:English
Published: Shiraz University of Medical Sciences 2019-10-01
Series:Middle East Journal of Cancer
Subjects:
Online Access:http://mejc.sums.ac.ir/article_45549_c1d73939215e8db127592850d9d7bec9.pdf
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author Fahimeh Rezazadeh
Soleiman Mohammadi-Samani
Fatemeh Talei
Mani Ramzi
Hajar Ashrafi
Zahra Emami
author_facet Fahimeh Rezazadeh
Soleiman Mohammadi-Samani
Fatemeh Talei
Mani Ramzi
Hajar Ashrafi
Zahra Emami
author_sort Fahimeh Rezazadeh
collection DOAJ
description <strong>Background:</strong> 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. <strong>Methods:</strong> 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). <strong>Results:</strong> 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. <strong>Conclusions:</strong> 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.
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spelling doaj.art-d730a620902f4b84bc1d0a3d915570302022-12-22T01:57:24ZengShiraz University of Medical SciencesMiddle East Journal of Cancer2008-67092008-66872019-10-0110434134910.30476/mejc.2019.78656.45549Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical TrialFahimeh Rezazadeh0Soleiman Mohammadi-Samani1Fatemeh Talei2Mani Ramzi3Hajar Ashrafi4Zahra Emami5Department of Oral and Maxillofacial Medicine, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, IranDepartment of Pharmaceutics and Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, IranStudents’ Research Committee, School of Dentistry, International Branch, Shiraz University of Medical Sciences, Shiraz, IranHematology Research Center, Department of Hematology and Medical Oncology, Shiraz University of Medical Sciences, Shiraz, IranDepartment of Pharmaceutics, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, IranDepartment of Periodontology, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran<strong>Background:</strong> 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. <strong>Methods:</strong> 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). <strong>Results:</strong> 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. <strong>Conclusions:</strong> 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.http://mejc.sums.ac.ir/article_45549_c1d73939215e8db127592850d9d7bec9.pdfMucositisphenytoinMucoadhesiveMouthwash
spellingShingle Fahimeh Rezazadeh
Soleiman Mohammadi-Samani
Fatemeh Talei
Mani Ramzi
Hajar Ashrafi
Zahra Emami
Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial
Middle East Journal of Cancer
Mucositis
phenytoin
Mucoadhesive
Mouthwash
title Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial
title_full Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial
title_fullStr Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial
title_full_unstemmed Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial
title_short Efficacy of Phenytoin Mucoadhesive Tablet versus Mouthwash on Chemotherapy-Induced Oral Mucositis: A Randomized Clinical Trial
title_sort efficacy of phenytoin mucoadhesive tablet versus mouthwash on chemotherapy induced oral mucositis a randomized clinical trial
topic Mucositis
phenytoin
Mucoadhesive
Mouthwash
url http://mejc.sums.ac.ir/article_45549_c1d73939215e8db127592850d9d7bec9.pdf
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