title: Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer.
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.
  
  
  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.
authors: Departament of Stomatology, School of Dentistry - University of Seville, "Virgen del Rocío" University Hospital, C/ Avicena s/n 41009. Seville, Spain, danieltl@us.es.
authors: Rosa-Maria
authors: RM
authors: Diaz-Sanchez
authors: Jerónimo
authors: J
authors: Pachón-Ibáñez
authors: Fátima
authors: F
authors: Marín-Conde
authors: Ángela
authors: Á
authors: Rodríguez-Caballero
authors: Jose-Luis
authors: JL
authors: Gutierrez-Perez
authors: Daniel
authors: D
authors: Torres-Lagares
mesh_terms: D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D001672:Biocompatible Materials; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002710:Chlorhexidine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000188:drug therapy* / Q000517:prevention & control*; D010865:Pilot Projects; D011446:Prospective Studies; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control*; D014014:Tissue Adhesives
chemical_list: D000891:Anti-Infective Agents, Local; D001672:Biocompatible Materials; D005782:Gels; D014014:Tissue Adhesives; D002710:Chlorhexidine