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

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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. © 2005 Wiley Periodicals, Inc. Head Neck 27: XXX–XXX, 2005