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Randomized Controlled Trial Multicenter Study Clinical Trial
Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis.
- R L Foote, C L Loprinzi, A R Frank, J R O'Fallon, S Gulavita, H H Tewfik, M A Ryan, J M Earle, and P Novotny.
- Mayo Clinic, Rochester, MN 55905.
- J. Clin. Oncol. 1994 Dec 1; 12 (12): 2630-3.
PurposeTo determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis.Patients And MethodsPatients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratification, they were randomized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash. Both groups were then similarly evaluated for mucositis and mouthwash toxicity.ResultsTwenty-five patients were randomized to receive the chlorhexidine mouthwash, while 27 received the placebo mouthwash. Treatment arms were well balanced. There was a trend for more mucositis and there was substantially more toxicity (eg, mouthwash-induced discomfort, taste alteration, and teeth staining) on the chlorhexidine arm.ConclusionIn contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation.
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