Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer

Med Oral Patol Oral Cir Bucal. 2015 May 1;20(3):e378-85. doi: 10.4317/medoral.20338.

Abstract

Background: to evaluate, in an initial way, the effectiveness of bioadhesive chlorhexidine gel 0.2% versus placebo as a preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy in patients diagnosed with head and neck cancer treated with chemoradiotherapy.

Material and methods: In this pilot study, 7 patients (range of age: 18- 65), having histological documented diagnosis of squamous carcinoma on the head and neck region in stage III and IV, and receiving combined radiation treatment and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22, and 43 of irradiation) were studied. Simultaneously, a topical application was performed with bioadhesive chlorhexidine gel 0.2% in the study group, and the placebo gel for the control group in 5 applications per day, from the time of initiation of cancer treatment to 2 weeks after completion of chemo-radiotherapy treatment (11 weeks of follow-up). The gradation of mucositis, pain, analgesic consumption, infectious complications, and treatment tolerance was measured.

Results: After 7 patients completed the protocol, any differences were observed between groups in an interval analysis. Mucositis, pain, and tolerance was similar in both groups.

Conclusions: Our results must be interpreted with caution due to the reduced sample size, but the use of bioadhesive chlorhexidine gel 0.2% didn't contribute clinical improvement to the oral mucositis induced by radiation therapy and chemotherapy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anti-Infective Agents, Local / therapeutic use*
  • Biocompatible Materials
  • Chemoradiotherapy / adverse effects*
  • Chlorhexidine / therapeutic use*
  • Double-Blind Method
  • Female
  • Gels
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Male
  • Middle Aged
  • Mucositis / drug therapy*
  • Mucositis / prevention & control*
  • Pilot Projects
  • Prospective Studies
  • Stomatitis / drug therapy*
  • Stomatitis / etiology
  • Stomatitis / prevention & control*
  • Tissue Adhesives*

Substances

  • Anti-Infective Agents, Local
  • Biocompatible Materials
  • Gels
  • Tissue Adhesives
  • Chlorhexidine