Development of a Novel Psycho-biological Tool for the Measurement of Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy and Concomitant Chemotherapy

Objective: Evaluate a patient-reported-oral mucositis scale (PROMS) on its own and in relation to existing measures of mucositis. Methods: 50 patients with head and neck cancer receiving radiotherapy were examined before cancer treatment, twice weekly during 6-7 weeks of therapy and post-therapy. Oral mucositis (OM) signs were evaluated clinically using NCI-CTCAE v.3, OMAS criteria and Total VAS-OMAS score. OM symptoms were recorded on PROMS-VAS questionnaires. Albumin and polymorphonuclear neutrophils were measured in saline rinses. The PROMS data were subjected to Spearman rank correlations versus the other clinical and biomarker data. Results: 33 participants completed the study. Significant correlations (p<.001) were seen between PROMS scores and other clinical and biomarker indicators of OM at a group level. Significant variations were seen between individuals. Conclusion: The PROMS tool demonstrates good correlation with other clinical indicators of OM and adds novel dimensions to currently available methods of assessments used for quantification of OM.