A RANDOMIZED TRIAL OF A NONABSORBABLE ANTIBIOTIC LOZENGE GIVEN TO ALLEVIATE RADIATION-INDUCED MUCOSITIS

BACKGROUND. The objective of this study was to determine whether a non absorbable antibiotic lozenge could alleviate radiation-induced oral m ucositis. METHODS. Patients scheduled to receive radiation therapy to more than one-third of the oral cavity mucosa were selected for the st udy. 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 inst ruments. RESULTS. Fifty-four patients were randomized to receive the a ntibiotic lozenge and 58 to receive the placebo. There were no substan tial differences or trends in mucositis scores between the two study a rms as measured by the health care providers. However, the mean patien t-reported mucositis score and the duration of patient-reported Grade 3-4 mucositis were both lower in the patients randomized to the antibi otic lozenge arm (P = 0.02 and 0.007, respectively). CONCLUSIONS. This prospective, controlled trial provides evidence to suggest that a non absorbable antibiotic lozenge can decrease patient-reported radiation- induced oral mucositis to a modest degree. Nonetheless, this evidence does nor appear to be compelling enough to recommend this treatment as part of standard practice. (C) 1997 American Cancer Society.