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

Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Anti-Infective Agents / therapeutic use*
  • Bacitracin / therapeutic use
  • Carcinoma, Squamous Cell / radiotherapy*
  • Clotrimazole / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Gentamicins / therapeutic use
  • Head and Neck Neoplasms / radiotherapy*
  • Humans
  • Male
  • Middle Aged
  • Quality of Life*
  • Radiotherapy / adverse effects
  • Stomatitis / etiology
  • Stomatitis / prevention & control*
  • Surveys and Questionnaires
  • Xerostomia / etiology
  • Xerostomia / prevention & control*


  • Anti-Infective Agents
  • Drug Combinations
  • Gentamicins
  • Bacitracin
  • Clotrimazole