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.
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.
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.
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 Neck27: XXX–XXX, 2005