RANDOMIZED TRIAL OF A CHLORHEXIDINE MOUTHWASH FOR ALLEVIATION OF RADIATION-INDUCED MUCOSITIS

Purpose: To determine whether a chlorhexidine mouthwash could alleviat e radiation-induced oral mucositis. Patients and Methods: Patients sch eduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratific ation, they were randomized in a double-blind manner to receive a chlo rhexidine mouthwash or a placebo mouthwash. Both groups were then simi larly evaluated for mucositis and mouthwash toxicity. Results: Twenty- five patients were randomized to receive chlorhexidine mouthwash, whil e 27 received the placebo mouthwash. Treatment arms were well balanced . There was a trend for more mucositis and there was substantially mor e toxicity leg, mouthwash-induced discomfort, taste alteration, and te eth staining) on the chlorhexidine arm. Conclusion: In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide bene fit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwa sh is detrimental in this clinical situation. (C) 1994 by American Soc iety of Clinical Oncology.