Abstract

9042 Background: Oral mucositis is one of the most common adverse effects of radiotherapy in head and neck tumors. We determined the efficacy of oral rinse benzydamine in prevention of radiation induced mucositis. Methods: Patients with head and neck cancers were enrolled in a randomize, placebo-controlled clinical trail to receive either benzydamine or placebo. All the cases received at least 50 Gy radiation to the oral cavity and oropharyngeal areas. The end points were comparison of highest grade of mucositis at the end of radiotherapy, frequency of grade 2 or more, the interval days to establishing grade 2 in the groups. Results: 100 patients with head and neck cancers were randomized in this trail. At the end of the study, 19 patients were excluded of the analysis due to minor side effects of drug, or stopping the radiotherapy. In 39 cases in the treated group, the frequency of mucositis grade 3 or more was 43.6% (17 cases) in contrast to 78.6% (33 cases) in 42 cases in the placebo group, which was significant (p=0.001). Mucositis grade 3 or more was 2.6 times frequent in placebo group (CI=95%, relative risk=1.38–5). At the end of RT, at least 42% of the treated group had mucositis grade 3 or more in contrast to at least 76% in the control group which was statistically significant. Intensity of mucositis was increased up to forth week of treatment in both groups to grade 2. In the treated group the grade of mucositis was approximately constant to the end of therapy; but in the control group it raised to grade 3 (p<0.001). The highest grade of mucositis during the treatment time was significantly different between two groups (p=0.049). The median interval days of establishing grade 2 mucositis was 3.6 days sooner in the placebo group (p=0.12). Conclusions: According to these results it seems that oral rinse benzydamine was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis in head and neck tumors. [Table: see text]

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