Abstract
ObjectivesTreatment 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 MethodsFifty 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.ResultsThirty-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).ConclusionPatient 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.
Highlights
Numerous clinical studies have focused on mucosal toxicity associated with cancer therapy, which is a common acute toxic effect of radiotherapy in head and neck (H&N) cancer patients [1,2,3]
When severe oral mucositis develops, cancer treatment may be modified or even halted which can limit the efficacy of treatment, and this is estimated to occur in about 10–25% of all patients [9,10,11], interruption rates as high as 47% have been reported [12]
A prospective single cohort study was designed to appraise the merits of using the Patient-Reported Oral Mucositis Symptom (PROMS) scale to measure how patients with H&N cancer were affected by oral mucositis during their cancer treatment
Summary
Numerous clinical studies have focused on mucosal toxicity associated with cancer therapy, which is a common acute toxic effect of radiotherapy in head and neck (H&N) cancer patients [1,2,3]. Severe oral mucositis can be very painful leading to decreased intake of food and drink and clinically significant weight loss or dehydration (Fig. 1). The psychosocial consequences of debilitating oral mucositis can be considerable since the additional morbidity and pain while undergoing the cancer therapy may cause anxiety and depression [5,6,7,8]. Severe oral mucositis can lead to increased use of healthcare resources, additional supportive care and even hospitalization. The direct economic consequences of oral mucositis induced by cancer therapies may be significant and require allocation of considerable resources [13,14,15]. It is critically important to develop and validate methods that can be used to quantify the oral mucositis experienced by patients in order to develop targeted interventions that efficiently reduce this particular adverse effect of cancer treatment [18]
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