title: Tetracaine oral gel in patients treated with radiotherapy for head-and-neck cancer: final results of a phase II study.
abstract: OBJECTIVE
  We performed a phase II study to assess feasibility, pain relief, and toxicity of a tetracaine-based oral gel in the treatment of radiotherapy (RT)-induced mucositis.
  
  
  METHODS
  Fifty patients treated with RT for head-and-neck cancer with clinical evidence of acute oral mucositis of grade>or=2 were scheduled to receive the tetracaine gel. A questionnaire evaluating the effect of the gel was given to all subjects.
  
  
  RESULTS
  In 38 patients (79.2%), a reduction in oral cavity pain was reported. Thirty-four patients (82.9%) reported no side effect. Seventy-one percent of patients had no difficulties in gel application. Unpleasant taste of the gel and interference with food taste were noticed in 5 (12%) and 16 patients (39%), respectively. Planned RT course was interrupted less frequently in patients who reported benefit from gel application than in patients who did not (p=0.014). None of the patients who experienced pain relief needed a nasogastric tube, opposite to the patients who did not report any benefit from gel application (p=0.001).
  
  
  CONCLUSIONS
  Tetracaine oral gel administration seemed feasible and safe while reducing RT-induced mucositis-related oral pain in a sizeable proportion of treated head-and-neck cancer patients. A trial designed to compare efficacy of this gel vs. standard treatment is warranted.
authors.affiliation: Department of Radiation Therapy of the European Institute of Oncology, Milan, Italy. daniela.alterio@ieo.it
authors.forename: Daniela
authors.initials: D
authors.lastname: Alterio
authors.forename: Barbara Alicja
authors.initials: BA
authors.lastname: Jereczek-Fossa
authors.forename: Gabriele Fulvio
authors.initials: GF
authors.lastname: Zuccotti
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Leon
authors.forename: Emanuela
authors.initials: E
authors.lastname: Omodeo Sale
authors.forename: Marcella
authors.initials: M
authors.lastname: Pasetti
authors.forename: Tiziana
authors.initials: T
authors.lastname: Modena
authors.forename: Paola
authors.initials: P
authors.lastname: Perugini
authors.forename: Luigi
authors.initials: L
authors.lastname: Mariani
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
mesh_terms: D000208:Acute Disease; D000278:Administration, Buccal; D000328:Adult; D000368:Aged; D000779:Anesthetics, Local / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D016001:Confidence Intervals; D005240:Feasibility Studies; D005260:Female; D005782:Gels; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013280:Stomatitis / Q000517:prevention & control*; D013748:Tetracaine / Q000627:therapeutic use*
chemical_list: D000779:Anesthetics, Local; D005782:Gels; D013748:Tetracaine