Allopurinol mouthwash for prevention or alleviation radiotherapy induced oral mucositis: a randomized, placebo-controlled trial

Background and the purpose of the study: A randomized, double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of an allopurinol mouthwash in prevention and alleviation of the oral radiotherapy induced mucositis.Methods: An allopurinol suspension mouthwash having proper physical stability at least for 6 weeks was prepared. A total of 24 patients with oral, nasopharynx or hypopharynx cancer were enrolled in the study. They were randomly allocated to receive either an allopurinol suspension or normal saline as placebo that were identical in appearance. Patients were instructed to use the suspension as a mouthwash 3 times a day for 3 minutes after beginning of each radiotherapy cycle. Patients were graded on the basis of severity of their own symptoms on a weekly basis by using WHO scale.Results: There were no differences in the severity of mucosits between the allopurinol and placebo-treated groups in first and second weeks of treatment (p =0.227, p = 0.121 respectively). In the third, fourth, fifth and sixth weeks, there were significant differences between two groups (p 0.05 in each weeks separately).Major conclusion: Result of this study support the hypothesis that an allopurinol mouthwash may prevents or alleviate oral mucositis induced by radiotherapy.