Abstract

Background: Previously, we reported that oral mucosal damage induced by radiotherapy is related to Candida-associated opportunistic infection (JSMO; 2011). Irsogladine maleate, a mucosal protective drug, has a preventive effect on radiotherapy-induced mucositis (JSMO; 2012). In the present study, we investigated the benefit of irsogladine maleate for oral mucositis and candidiasis induced by radiotherapy in patients with head and neck cancer. Methods: A prospective randomized study of 43 patients (10 female, 33 male) with advanced head and neck cancer was conducted from November 2010 to December 2011. Group A (n = 21) received irsogladine 4 mg during radiotherapy and Group B (n = 22) received radiotherapy without irsogladine. We evaluated oral health retrospectively by using the Revised Oral Assessment Guide (ROAG) and assessing tongue fur. Results: After 30 Gy of radiotherapy, the ROAG score for the lips in group A was significantly lower than in group B. Moreover, after 20 Gy of radiotherapy, the score for the oral mucosa and gingiva in group A was significantly lower than in group B. A significant increase in tongue fur compared with electronic medical records was observed in both groups. However, the score in group A was significantly lower than in group B at 20, 30 and 50 Gy of radiotherapy. Conclusion: Irsogladine appears to be useful for the prevention of oral mucositis and candidiasis associated with radiotherapy in patients with head and neck cancer.

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