• J Res Med Sci · Jan 2019

    A novel formulation for radiotherapy-induced oral mucositis: Triamcinolone acetonide mucoadhesive film.

    • Fahimeh Pakravan, Parichehr Ghalayani, Hamid Emami, Isfahani Mehdi Nasr MN Emergency Medicine Research Center, Department of Emergency Medicine, Al Zahra Research Institute, Isfahan University of Medical Sciences, Isfahan,, and Pegah Noorshargh.
    • Dental Implants Research Center, Department of Oral Medicine, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
    • J Res Med Sci. 2019 Jan 1; 24: 63.

    BackgroundThe 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 MethodsIn 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.ResultsMean ± 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).ConclusionTA film could be considered as an effective approach for reducing the mucositis grading and pain score in the patients with OM.

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