RADIATION-INDUCED MUCOSITIS IN PATIENTS WITH HEAD AND NECK CANCER: SHOULD THE SIGNS OR THE SYMPTOMS BE MEASURED?

OBJECTIVE: To improve understanding of how patient-reported outcomes following radiation therapy for head and neck cancer may be influenced by factors beyond the local effects of the radiotherapy. METHODS: Initially, 50 patients with head and neck cancer who were scheduled to undergo radiation therapy consented to participate in this prospective observational study. The participants underwent an oral examination before commencement of therapy and twice weekly over the therapy period. The 33 participants who finished the therapy underwent one more examination 4 to 6 weeks after its completion. At each session, clinical signs of oral mucositis were recorded with clinician-based scoring tools, and participants completed a questionnaire based on a visual analogue scale to record the perceived degree of impairment of common oral functions caused by oral mucositis. The strength of the correlation between these signs and symptoms at various points throughout the study period was appraised using a linear mixed model with robust repeated measures. The study participants with the most extensive manifestations of oral mucositis but only minor pain and limited adverse effects on oral functions (n=6) were contrasted with those who had limited mucositis but more severe pain and adverse effects (n=7). In addition, study participants with poor to moderate correlations between signs and symptoms (n=5) were contrasted with those who had very good correlations (n=10). Simple bivariate tests were used for these comparisons. RESULTS: Correlations between various signs and symptoms at all time points varied markedly at the individual level. The characteristics of study participants in the 2 subcohorts defined by poor to moderate and very good correlations between signs and symptoms were comparable, except perhaps in terms of age (p<0.05, t test). Similarly, the participants in the 2 subcohorts defined by high manifestation with minor complaints and vice versa did not differ with regard to the variables recorded. CONCLUSION: Patients with head and neck cancer often report adverse effects of radiation-related oral mucositis on daily oral functions that are discordant with objective clinical findings. Patient-reported outcomes should be included in any interventional studies of oral mucositis, and trends over time should be analyzed within individuals, rather than between individuals.

Symptoms Reported by Head and Neck Cancer Patients during Radiotherapy and Association with Mucosal Ulceration Site and Size: An Observational Study.

BACKGROUND: Self-reported pain and impairment of oral functions varies markedly and often in spite of extensive oral mucositis (OM). The aim of the current study was to appraise how patient-reported debilitation caused by OM is influenced by the extent and possibly location of the OM lesions. METHODS: Patients with head and neck cancer undergoing radiotherapy were examined before treatment, twice weekly during 6-7 weeks of therapy, and 3-4 weeks after therapy completion. OM signs of 33 participants were evaluated using the Oral Mucositis Assessment Scale (OMAS), while OM symptoms were recorded using Patient-Reported Oral Mucositis Symptom (PROMS)-questionnaires. Changes in OM experience as a function of OM signs was undertaken by comparing the aggregated and individual PROMS scale values at the point of transition of OMAS ulceration scores between 0 to 1, 1 to 2 and 2 to 3, respectively in the nine intra-oral locations designated in the OMAS. ANOVA with pairwise contrasts using the LSD procedure was applied for comparisons of mean changes of PROMS scale values for the participants who experienced an OMAS score of 2 or more during therapy (n=24). RESULTS: Impairment of eating hard foods was more when the OMAS score for ulceration anywhere in the mouth or in the soft palate changed from 1 to 2, compared to between score 0 and 1 (p=.002 and p=.05) or between score 2 and 3 (p=.001 and p=.02). Mouth pain increased more upon transition of OMAS score anywhere in the mouth from 1 to 2 compared to 0 to 1 (p=.05). CONCLUSION: The relationship between patient-reported impairment of oral function and pain caused by OM ulceration is not linear, but rather curvilinear. Our findings should prompt investigators of future interventional trials to consider using a less severe outcome than maximum OM scores as the primary study outcome.

Assessment of cancer therapy-induced oral mucositis using a patient-reported oral mucositis experience questionnaire.

OBJECTIVES: Treatment of oral mucositis (OM) is challenging. In order to develop and test useful treatment approaches, the development of reliable, reproducible and simpler methods than are currently available for assessment of OM is important. A Patient-Reported Oral Mucositis Symptom (PROMS) scale was assessed in patients with head and neck cancer to determine if the patient-reported OM experience, as determined by using the PROMS scale, correlate with OM assessed by clinician-based scoring tools. MATERIALS AND METHODS: Fifty patients with head and neck cancer and undergoing radiotherapy consented to participate. They were examined before cancer treatment and twice weekly during 6-7 weeks of therapy and once 4-6 weeks after therapy. Signs of OM were evaluated using the 3 clinician-based scoring tools; NCI-CTCAE v.3, the OMAS criteria and the Total VAS-OMAS. The participants' OM experiences were recorded using PROMS-questionnaires consisting of 10 questions on a visual analogue scale. Spearman rank correlation test were applied between the PROMS scale values and the clinician-determined scores. Repeated measures mixed linear models were applied to appraise the strengths of correlation at the different time points throughout the observation period. RESULTS: Thirty-three participants completed all stages of the study. The participant experience of OM using the PROMS scale demonstrates good correlations (Spearman's Rho 0.65-0.78, p<0.001) with the clinician-determined scores on the group level over all time points and poor to good correlations (Spearman's Rho -0.12-0.70, p<0.001) on the group level at different time points during and after therapy. When mouth opening was problematic, i.e. during the 6th and 7th week after commencing cancer treatment, the Spearman's Rho varied between 0.19 and 0.70 (p<0.001). CONCLUSION: Patient experience of OM, as reported by the PROMS scale may be a feasible substitute for clinical assessment in situations where patients cannot endure oral examinations.