title: Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis.
abstract: BACKGROUND
  The National Cancer Institute of Canada Clinical Trials Group undertook a multicenter, randomized, double-blind controlled trial of an oral antimicrobial versus placebo to prevent and treat mucositis. We present the quality of life (QOL) analysis for this trial.
  
  
  METHODS
  One hundred thirty-eight patients were randomly assigned. QOL data were collected every 2 weeks before, during, and after radiotherapy. The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) and a Trial Specific Checklist (TSC) were used.
  
  
  RESULTS
  The antimicrobial lozenge did not impact QOL. The principal acute side effect of radiotherapy is oral pain, affecting more than 90% of patients. Role function is impacted during treatment, and patients experience fatigue. Appetite was reported to markedly increase during radiotherapy. There was a dramatic and persistent increase in dry mouth.
  
  
  CONCLUSIONS
  This study highlights the benefits of combining the EORTC QLQ-30 with an "oral" TSC in a randomized controlled trial and provides valuable baseline data for their use with an objective mucositis scoring system.
authors.affiliation: Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver Centre, 600 West 10th Ave, Vancouver, BC, Canada V6Z 4E6. GDuncan@bccancer.bc.ca
authors.forename: Graeme G
authors.initials: GG
authors.lastname: Duncan
authors.forename: Joel B
authors.initials: JB
authors.lastname: Epstein
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Tu
authors.forename: Samy
authors.initials: S
authors.lastname: El Sayed
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.forename: Jon
authors.initials: J
authors.lastname: Ottaway
authors.forename: Joe
authors.initials: J
authors.lastname: Pater
mesh_terms: D000284:Administration, Oral; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001414:Bacitracin / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D003022:Clotrimazole / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005839:Gentamicins / Q000627:therapeutic use; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D014987:Xerostomia / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000890:Anti-Infective Agents; D004338:Drug Combinations; D005839:Gentamicins; D001414:Bacitracin; D003022:Clotrimazole