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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.

Author(s): Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J, National Cancer Institute of Canada Clinical Trials Group

Affiliation(s): Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver Centre, 600 West 10th Ave, Vancouver, BC, Canada V6Z 4E6. GDuncan@bccancer.bc.ca

Publication date & source: 2005-05, Head Neck., 27(5):421-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.

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