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A Novel Formulation for Radiotherapy-Induced Oral Mucositis: Triamcinolone Acetonide Mucoadhesive Film Publisher



Pakravan F1 ; Ghalayani P1 ; Emami H2 ; Isfahani M3 ; Noorshargh P4
Authors
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Authors Affiliations
  1. 1. Dental Implants Research Center, Department of Oral Medicine, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
  2. 2. Department of Radiotherapy, Isfahan University of Medical Sciences, Isfahan, Iran
  3. 3. Emergency Medicine Research Center, Department of Emergency Medicine, Al Zahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
  4. 4. Young Researchers and Elite Club, Isfahan Khorasgan Branch, Islamic Azad University, Isfahan, Iran

Source: Journal of Research in Medical Sciences Published:2019


Abstract

Background: The main purpose of this study was to evaluate the effectiveness of triamcinolone acetonide (TA) mucoadhesive films versus placebo as a preventive and therapeutic intervention of oral mucositis (OM) induced by radiotherapy for head-and-neck cancer (HNC) patients. Materials and Methods: In this double-blind, randomized case-controlled clinical trial, 60 HNC patients were randomized to receive TA mucoadhesive films (n = 30) or placebo mucoadhesive films (n = 30) taken four times daily. Mucositis severity was assessed during the course of radiation therapy using the World Health Organization scales, and pain scores were assessed using visual analog scale. Repeated measures ANOVA was used for data analysis. Results: Mean ± standard deviation age of the TA group was 58.53 ± 8.89 years and 60% were male, whereas in the placebo group, it was 56.46 ± 9.36 years and 56.7% were male (P > 0.05). The mean value of pain score was significantly reduced in the TA group (5.36 ± 1.29 vs. 2.20 ± 2.02) compared with the placebo group (5.34 ± 0.78 vs. 4.69 ± 0.77) during 4 weeks (P < 0.001); repeated measures ANOVA analysis showed that the mean value of grade mucositis was significantly reduced in the TA group (2.40 ± 0.49 vs. 0.96 ± 0.81) compared with the placebo group (2.36 ± 0.80 vs. 1.86 ± 0.93) during 4 weeks (P < 0.001). Conclusion: TA film could be considered as an effective approach for reducing the mucositis grading and pain score in the patients with OM. ©2019 Journal of Research in Medical Sciences | Published by Wolters Kluwer - Medknow.
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