Oral Mucositis Daily Questionnaire Research Articles

Oral mucositis in pediatric and adolescent patients undergoing chemotherapy: the impact of symptoms on quality of life

This study sought to characterize the range of oral symptoms and affect upon quality of life reported by pediatric and adolescent patients in relation to the severity of oral mucositis and symptom burden during chemotherapy. A multicenter study included 140 patients between 6 and 18 years of age who had been treated with chemotherapy. Participants completed the self-report Mouth and Throat Soreness-related Questions of the Oral Mucositis Daily Questionnaire (OMDQ) for 14 days and the Oral Mucositis-specific Quality of Life Measure (OMQoL) at baseline, day 7, and day 14. The incidences of non-severe and severe mucositis were 23% (n = 32) and 18% (n = 25), respectively. The symptoms reported by the patients with oral mucositis were related to eating (82.4%), swallowing (78.9%), drinking (75.4%), sleeping (71.9%), and talking (43.9%). Approximately 39% (22 out of 57) of patients with mucositis reported at least two simultaneous symptoms resulting from oral mucositis. About a quarter of them (25%, 14 out of 57) reported having all five symptoms concurrently. The mean area under curve (AUC) scores for symptom severity were significantly higher in the severe mucositis group (mean 0.95 to 1.21; 95% CI 0.76 to 1.34) compared with the non-severe (mean 0.50 to 1.06; 95% CI 0.35 to 1.30) and the without mucositis (mean 0 to 0.09; 95% CI 0 to 0.12) groups (p < 0.001). Wald's method generated two clusters: a low-symptom group (n = 102; 72.9%) and a high-symptom group (n = 38; 27.1%). The high-symptom group reported significantly lower mean AUC OMQoL subscale scores (mean 62.2 to 79.2; 95% CI 55.9 to 88.2 versus mean 93.1 to 97.1; 95% CI 91.7 to 98.3, respectively; p < 0.001) and higher mean AUC distress score (mean 1.9 ± 0.5; 95% CI 1.7 to 2 versus mean 1.1 ± 0.2; 95% CI 1.1 to 1.1, respectively; p < 0.001) than the low-symptom group. Swallowing and sleeping had the strongest standardized coefficients in OMQoL subscale scores (swallowing: -0.321 to -0.767; sleeping: -0.406 to -0.773), as well as distress scores (0.468 and 0.557, respectively). Severe oral mucositis is a common cause of morbidity in pediatric and adolescent patients undergoing chemotherapy. High-symptom burden due to mucositis may have profound impacts on patient quality of life and levels of psychological distress.

Psychometric properties of the Oral Mucositis Daily Questionnaire for child self-report and importance of mucositis in children treated with chemotherapy

The objectives of this study were to examine the psychometric properties of the self-report Oral Mucositis Daily Questionnaire (OMDQ) and to measure the importance of mucositis in children receiving intensive chemotherapy. Children ≥ 12 years of age receiving intensive chemotherapy for leukemia/lymphoma or undergoing stem cell transplantation were asked to complete the OMDQ daily for 21 days after chemotherapy. Other measures of mucositis obtained concurrently with OMDQ included the World Health Organization (WHO) mucositis scale, the pain visual analog scale (VAS), and the Functional Assessment of Cancer Therapy Esophageal Cancer Sub-scale (FACT-ECS). The importance of mucositis was estimated using a VAS, time trade-off technique, and willingness to pay to avoid mucositis. Fifteen children participated. Test-retest reliability demonstrated at least moderate correlation for all questions within the OMDQ. Assessment of construct validity of the OMDQ revealed at least moderate correlation with WHO, VAS, and FACT-ECS for questions regarding pain, swallowing, drinking, and eating. Effect on sleeping and talking had lower correlations than that expected a priori. The diarrhea question of the OMDQ did not correlate with other measures of mucositis. Severe mucositis is important to children, while mild mucositis is less important to them. Children were willing to pay moderate amounts of money to prevent mucositis. The OMDQ exhibits test-retest reliability, and most questions show construct validity with the exceptions of the sleep, talking, and diarrhea questions. Therefore, the OMDQ should not be used unmodified as a self-report instrument in children with cancer. Severe mucositis is of importance to these children.

Incidence and risk factors of oral mucositis in paediatric and adolescent patients undergoing chemotherapy

There is a dearth of studies with respect to oral mucositis (OM) in the paediatric and adolescent populations. The purpose of this prospective cohort study was to examine the incidence and risk factors associated with OM in paediatric and adolescent patients receiving chemotherapy. OM assessments were made daily until 14days after chemotherapy using the self-report Mouth and Throat Soreness-Related Questions of the Oral Mucositis Daily Questionnaire (OMDQ MTS). Potential risk factors included age, gender, prior OM, anxiety level, cancer diagnosis, nausea/vomiting, use of growth factor, neutrophil count, liver enzymes, and creatinine value. Multiple logistic, Cox proportional hazards, and ordinal regression analyses were used to determine risk factors for the incidence and time to onset of MTS scores of ⩾2, and MTS scores across 14days by AUC categories, respectively, after adjusting for chemotherapy. A total of 140 patients who were 6-18years of age were evaluated. Forty-one percent (95% CI, 32.6-48.8%) developed OM; of these, 23% and 18% reported a maximum MTS score of 2 and 3-4 as the worst OM, respectively. The mean time to onset of OM was 4.7±2.7days with a mean duration of 6.3±4days. Prior OM (RR 1.90-3.94), a higher level of anxiety (RR 1.27-1.46), WHO grade 1-2 (RR 1.86-4.59) and 3-4 (RR 3.08-9.19) neutropenia were significantly associated with a higher probability of the incidence, earlier onset, and greater severity of OM, after controlling for chemotherapy (p<0.01). OM was associated with indirect cytotoxicity, prior OM, and anxiety level after controlling for chemotherapy where neutropenia was found to be the most important factor.

Interim Analysis of Randomized Phase II Study of Recombinant Human Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy with Stem Cell Transplantation for Hematologic Malignancies

AbstractAbstract 905Oral mucositis (OM) develops in 40–80% of patients undergoing intensive chemotherapy with stem cell transplantation (SCT) which is often debilitating and influences the quality of life (QoL). A novel drug, recombinant human epidermal growth factor (rhEGF), recently demonstrated promising efficacy and minimal toxicity in the prevention of OM in patients with head and neck cancer receiving radiotherapy (Wu HG et al, Cancer 2009). To evaluate the efficacy and safety of rhEGF for prevention and treatment of OM during SCT, a prospective randomized double-blind placebo-controlled phase II study is being performed (ClinicalTrials.gov identifier, NCT00845819). In this report, results of the scheduled interim analysis are presented. Patients for whom the procedure of SCT for hematologic malignancies was planned were eligible for this study. Patients were randomly assigned to either the rhEGF group or the placebo group, at a 1:1 ratio. Patients were instructed to spray either the 50 μg/mL rhEGF or the placebo over their entire oral mucosa twice daily and to swallow the residual. The rhEGF was administered at the start of intensive chemotherapy until the time of their recovery from neutropenia (absolute neutrophil count >1000 /μL for 3 consecutive days) and disappearance of OM. The severity of OM was assessed daily using the World Health Organization (WHO) scale. Patients also completed an Oral Mucositis Daily Questionnaire (OMDQ) to assess patient-reported QoL (Stiff PJ et al, J Clin Oncol 2006). A total of 138 patients are planned to be enrolled in this study. This interim analysis was performed after the acquisition of data on the 58 patients who were enrolled between March 2009 and June 2010. Twenty-nine patients were assigned to each group. Patient median age in the rhEGF group was 56 (range, 18–63) years and 51 (range, 19–65) years in the placebo group. Autologous SCT was performed on 26 patients (89.7%) from each group, and allogeneic SCT, in the rest (10.3%). Baseline characteristics were not significantly different between the 2 groups. The difference in the incidence of grade 3 or 4 OM between the 2 groups was not significant (p=0.283). The duration of OM in patients with grade 3 or 4 OM tended to be shorter, however, in the rhEGF group than in the placebo group (8.0 [range, 2.0–23.0] days vs. 18.5 [range, 2.0–34.0] days; p=0.108). This result is also supported by the significantly shorter duration of medication use in patients with grade 3 or 4 OM in the rhEGF group than in the placebo (28.0 [range, 17.0–44.0] days vs. 39.5 [range, 17.0–61.0] days; p=0.050). The OMDQ analysis using area-under-the-curve calculation (with a lower score for milder limitation) for patients with grade 3 or 4 OM also showed that rhEGF significantly reduced limitations in swallowing (26.0 [range, 8.0–75.0] vs. 51.5 [range, 19.0–92.0]; p=0.039) and drinking (25.0 [range, 7.0–73.5] vs. 55.5 [range, 20.0–86.0]; p=0.042) compared to placebo. The duration of administration of total parenteral nutrition (TPN) was significantly shorter in the rhEGF group than in the placebo group (7.0 [range, 0.0–25.0] days vs. 16.5 [range, 10.0–32.0] days; p=0.012) in patients with grade 3 or 4 OM. A similar result was observed for the duration of opioid analgesics use (6.0 [range, 0.0–25.0] days vs. 17.0 [range, 0.0–48.0] days; p=0.117). In patients with grade 3 or 4 OM, the rhEGF group showed a significantly shorter length of hospitalization than the placebo group (27.0 [range, 18.0–65.0] days vs. 41.5 [range, 27.0–94.0] days; p=0.022). Adverse events between the 2 groups were not statistically significant. The adverse events in the rhEGF group were nausea (n=2, 6.9%), oral pain (n=1, 3.4%), and taste alteration (n=1, 3.4%). No grade 3 or 4 adverse events developed. To summarize, in patients who received SCT for hematologic malignancies, rhEGF tended to reduce the duration of grade 3 or 4 OM and significantly reduced limitations in swallowing and drinking. In addition, rhEGF significantly reduced the duration of TPN use and hospitalization, and tended to reduce the duration of opioid analgesics use. The rhEGF was generally well tolerated with a favorable safety profile. The results of this interim report demonstrate that rhEGF has a role in the treatment of OM induced by intensive chemotherapy with SCT, and improves QoL. This study is still ongoing, and the final results are expected to be available within 2 years. Disclosures:Off Label Use: Recombinant human epidermal growth factor is a novel drug, which is officially approved for treatment of diabetic foot in Korea. This drug is currently not approved for treatment of oral mucositis by both the US FDA and the Korean FDA yet. In the present study, we used this drug to evaluate efficacy and safety of this drug for prevention and treatment of oral mucositis induced by intensive chemotherapy with stem cell transplantation.

Reliability and construct validity of the oral mucositis daily questionnaire in children with cancer

BackgroundThe objective of this study was to examine the test–retest reliability and construct validity of parent-reported Oral Mucositis Daily Questionnaire (OMDQ) in children receiving intensive chemotherapy. MethodsParents of children with cancer receiving intensive chemotherapy for leukaemia/lymphoma or undergoing stem cell transplantation (SCT) were asked to complete OMDQ daily for 21d after chemotherapy. Other measures of mucositis obtained concurrently with OMDQ included the World Health Organization (WHO) Mucositis Scale, pain Visual Analogue Scale (VAS) and the Functional Assessment of Cancer Therapy Esophageal Cancer Sub-scale (FACT-ECS). ResultsParents of 59 children (median age=5.62) provided complete OMDQ data for inclusion in analysis. The majority of children (73%) received SCT. Test–retest reliability of OMDQ exceeded the expected moderate reliability threshold established a priori and in particular, was good to excellent when mucositis was expected. In general, items of OMDQ that relate to pain, swallowing, drinking, eating and talking demonstrated moderate correlations with WHO, VAS and FACT-ECS indices with correlation coefficients⩾0.5. ConclusionsParent-report of a modified version of OMDQ is reliable and the questions relating to mouth and throat pain, as well as effect on function display construct validity for this population of children receiving intensive chemotherapy.

Determining the Understandability and Acceptability of an Oral Mucositis Daily Questionnaire

Oral mucositis research in children receiving anticancer therapy has been impeded by the lack of an acceptable, appropriate assessment scale. Some scales attempt to measure subjective symptoms associated with mucositis such as pain and difficulty swallowing. These types of patient-reported outcomes are gaining prominence in clinical trials because they capture the perspective of the patients in whom the intervention is designed to benefit. In mucositis research, very few patient-reported outcome measures have been developed. The aim of this study was to determine whether an adaptation of the adult-validated Oral Mucositis Daily Questionnaire is understandable and acceptable for use in the pediatric oncology/hematology population. Twelve subjects were asked to rate their opinion of understandability and acceptability of the adapted Oral Mucositis Daily Questionnaire. As a result of their comments, minor changes were made. Evaluation of the psychometric properties of this instrument can now be performed.

Oral mucositis is associated with increased resource use among patients receiving treatment for cancers of the head and neck

6070 Background: Oral mucositis (OM) is the oral manifestation of mucosal injury (MUI), and is a common, bothersome, and treatment-interrupting toxicity of chemoradiation therapy for squamous cell cancers (SCC) of the head and neck. Retrospective studies have reported that OM increases healthcare resource use. We present interim results of an international, multicenter, prospective study undertaken to characterize the clinical and economic burden of OM in patients with cancers of the oral cavity (OC), oropharynx (OP), larynx (L) and hypopharynx (HP). Methods: Patients (pts) with histologically proven SCC of the designated anatomical sites, whose planned treatment included full-cycle conventional or intensity modulated (IM) radiation therapy (RT) with or without chemotherapy, were enrolled at least one week prior to the start of treatment. Pts completed the Oral Mucositis Daily Questionnaire (OMDQ), a validated questionnaire developed to document patient-reported symptoms of OM and MUI including mouth and throat soreness (MTS), at baseline and daily throughout RT. MTS was assessed using a 5-point numeric rating scale, ranging from 0 (“no soreness”) to 4 (“extreme soreness”). Results: Of the first 61 pts to complete RT, 72% had cancers of the OC or OP, 49% received IMRT with concomitant chemotherapy, and 68% were male. 95% of pts reported OM symptoms (MTS&gt;0); 80% had one or more scores =2. Pts with OC or OP cancers reported more symptoms than those with L or HP tumors (mean maximum score: 3.3 vs 2.8; p= 0.12). MTS scores were positively related to levels of resource use. Conclusions: Symptoms of radiation-induced OM are positively correlated with levels of resource utilization in patients with head and neck cancers. No significant financial relationships to disclose. [Table: see text]

Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT)

Oral mucositis (OM) is a frequent complication of myeloablative therapy and HSCT. We evaluated the feasibility, reliability, and validity of a new patient self-reported daily questionnaire on OM and its impact on daily functions. This OM Daily Questionnaire (OMDQ), containing 10 items, was developed for use in palifermin clinical trials. In a phase 3 study, 212 patients received palifermin or placebo for three consecutive days before conditioning and three consecutive days after HSCT. Compliance rates were consistently >80% for most patients. Mouth and throat soreness (MTS) and MTS-Activity Limitations (MTS-AL) (swallowing, drinking, eating, talking, and sleeping) scores on consecutive days were highly correlated (days 7,8 = 0.70-0.86; test-retest reliability). Correlations among items measuring the same construct ranged between 0.5 and 0.8 (internal consistency reliability). The WHO Oral Toxicity scale was the clinical comparator to assess the criterion, discriminative, and evaluative validities of MTS-related questions. Most correlation coefficients between the WHO and MTS ranged between 0.45 and 0.55. Patients with more severe WHO OM grades had higher MTS mean scores. Changes in MTS scores were similar, but patients detected changes 1-3 days earlier than clinicians. In conclusion, the OMDQ is a feasible, reliable, valid, and responsive patient-reported measure of OM severity.

Palifermin Reduces Patient-Reported Mouth and Throat Soreness and Improves Patient Functioning in the Hematopoietic Stem-Cell Transplantation Setting

To describe patient-reported outcomes of mouth and throat soreness (MTS) and related sequelae on daily activities from a phase III study of palifermin in the autologous hematopoietic stem-cell transplantation (HSCT) setting and to compare patient self-evaluations with clinicians' assessments of oral mucositis using objective scales. Patients (n = 212) received palifermin (60 microg/kg/d) or placebo for 3 days before total-body irradiation (12 Gy), etoposide 60 mg/kg, and cyclophosphamide 100 mg/kg, and 3 days after HSCT. Patients completed a daily questionnaire (Oral Mucositis Daily Questionnaire [OMDQ]) evaluating MTS severity and its effects on daily functional activities. Patients' self-assessment data were compared with clinicians' assessments of oral mucositis using the objective scales. Palifermin reduced the incidence and duration of severe oral mucositis, as assessed by both clinicians and patients. Comparisons between patient and clinician assessments demonstrated that the average daily scores between mucositis grade and subjective (MTS) instruments were similar, although patients reported MTS onset, peak, and resolution earlier (1 to 3 days) than clinicians' assessments. Patients receiving palifermin reported statistically significant improvements (P < .001) in daily functioning activities (swallowing, drinking, eating, talking, sleeping) and required significantly less narcotic opioids (P < .001); improvement in the patient's overall physical and functional well-being was also reported. This was confirmed by the results of the Functional Assessment of Cancer Treatment questionnaire. These results support the clinical benefit of palifermin in the HSCT setting, providing evidence that a patient's self-assessment instrument (OMDQ) may serve as an alternative tool to assess oral mucositis severity in clinical trials.