Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis

J Clin Oncol. 1994 Dec;12(12):2630-3. doi: 10.1200/JCO.1994.12.12.2630.

Abstract

Purpose: To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis.

Patients and methods: Patients 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.

Results: Twenty-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.

Conclusion: In 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Chlorhexidine / adverse effects
  • Chlorhexidine / therapeutic use*
  • Confidence Intervals
  • Double-Blind Method
  • Female
  • Head and Neck Neoplasms / radiotherapy*
  • Humans
  • Male
  • Middle Aged
  • Mouth Mucosa / drug effects
  • Mouth Mucosa / radiation effects
  • Mouthwashes / therapeutic use*
  • Radiation Injuries / drug therapy*
  • Radiotherapy Dosage
  • Stomatitis / drug therapy*
  • Stomatitis / etiology

Substances

  • Mouthwashes
  • Chlorhexidine