A randomized trial of a nonabsorbable antibiotic lozenge given to alleviate radiation-induced mucositis

BACKGROUND. The objective of this study was to determine whatever a nonabsorbable antibiotic lozenge could alleviate radiation-induced oral mucositis. METHODS. Patients scheduled to receive radiation therapy to more than one-third of the oral cavity mucosa were selected for the study. After stratification, patients were randomized to receive either a nonabsorbable antibiotic lozenge or a placebo. Both groups were then evaluated for mucositis by health care providers and self-report instruments. RESULTS. Fifty-four patients were randomized to receive the antibiotic lozenge and 58 to receive the placebo. There were no substantial differences or tends in mucositis scores between the two study arms as measured by the health care providers. However, the mean patient-reported mucositis score and the duration of patient-reported Grade 3-4 mucositis were both lower in the patients randomized to the antibiotic lozenge arm (P = 0.02 and 0.007, respectively). CONCLUSIONS. This prospective, controlled trial provides evidence to suggest that a nonabsorbable antibiotic lozenge can decrease patient-reported radiation-induced oral mucositis to a modest degree. Nonetheless, this evidence does not appear to be compelling enough recommend this treatment as part of standard practice.