Oral Mucositis Experience in Head and Neck Cancer Patients

Objective: Validate a recently developed tool for assessing patient reported oral mucositis (OM), the Patient Reported Oral Mucositis Scale (PROMS) (Kushner ea 2008) amongst head and neck cancer patients undergoing curative therapy. Methods: Patients diagnosed with cancer localized to the head and neck and receiving radiation therapy, with or without concomitant chemotherapy at Princess Margaret Hospital, Toronto, Ontario were invited to partake in a prospective study. The study protocol was approved by the University Health Network Research Ethics Board, ref. 09-0231-CE. Following patient consent, a priori inclusion and exclusion criteria were used for screening purposes. A power calculation identified a need for 20 patients to reach 80% power. The patients were examined clinically once before radiation therapy and thereafter twice weekly during the course of their 6-7 weeks treatments as well as once again six weeks following the completion of the cancer treatment. OM was evaluated clinically according to two commonly used assessment tools, the NCI-CTC-criteria and the OMAS scale. In addition, the participants completed a PROMS VAS questionnaire and submitted a saline rinse for measurements of albumin and polymorphnuclear neutrophils (PMN). Laboratory analyses of the samples were done according to routine procedures. The patient-reported OM experience data were correlated with the clinical and biomarker data and subjected to parametric and non-parametric statistical tests. Results: Of initially 50 consenting participants 36 completed more or less regularly the whole course of clinical examinations. The change from baseline was statistically significant for all markers of oral mucositis as shown in table below. Proportions, averages and min/max values:

Conclusion: The PROMS tool for self-reported experiences of oral mucositis demonstrate good correlation with currently used clinical examination criteria as well as biomarkers amongst head and neck cancer patients undergoing curative therapy.