Oral Mucositis Daily Questionnaire Research Articles

Psychometric Properties of the Oral Mucositis Daily Questionnaire in Turkish Children with Cancer

Purpose: The Oral Mucositis Daily Questionnaire (OMDQ) can be used in pediatric cancer patients. This study aimed to investigate the Turkish validity and reliability of the OMDQ in children aged 8 - 18 years diagnosed with cancer at two university hospital pediatric hematology/oncology clinics. 
 Methods: Children’s International Mucositis Evaluation Scale (ChIMES) and the World Health Organization (WHO) Oral Mucositis Grading Scale were used in parallel form reliability. Thirty children with oral mucositis were included in the study at the inter-rater and test-retest reliability on the 14th and 15th days of chemotherapy treatment. Ninety-two children were included for the construct validity. Kappa Compliance Analysis, Spearman’s correlation coefficient, and Cronbach’s alpha were evaluated.
 Results: The content validity index was calculated for the scores given by the experts and the items were changed between .90 and 1.00. On the 14th and 15th days of chemotherapy treatment, the correlation values for each item of OMDQ were found to be over .64. In the construct validity, the patients’ mean age was 11.7±3.3, and 46.7% diagnosed with Acute Lymphoblastic Leukemia. Cronbach Alpha value of OMDQ was .92. The OMDQ items showed a positive correlation with each other except for diarrhea questions. According to the WHO Oral Mucositis Grading Scale, 55.4% of the patients had grade 1 mucositis. The similar items of OMDQ and ChIMES had a positive significant relationship (p < .001). 
 Conclusion: The Turkish version of the OMDQ was a valid and reliable instrument in children aged 8 - 18 years diagnosed with cancer.

Evaluation of the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

Background: Oral mucositis (OM) is one of the most prevalent complications leading to severe pain, difficulty eating, prolonged hospitalization, and life-threatening septic condition in patients receiving chemotherapy containing conditioning regimen prior to autologous hematopoietic stem cell transplantation (auto-HSCT). MIT-001 is a novel small molecule functioning as a mitochondria-targeted radical trapping agent (RTA) that effectively inhibits cellular ferroptosis/necrosis and cytokine production via blockade of reactive oxygen species (ROS) generation and calcium accumulation in the mitochondria. The current clinical study was designed to evaluate the safety, efficacy by prevention of OM and pharmacokinetics of MIT-001 in patients with lymphoma or multiple myeloma (MM) undergoing chemotherapy prior to auto-HSCT. Methods: This phase IIa study consists of two parts: part 1 is an open label dose-escalating study dosing from 5 mg, 10 mg and up to 20 mg of MIT-001 to determine the recommended Part 2 Dose (RP2D) via evaluating the efficacy of OM, safety and pharmacokinetic characteristics of MIT-001, whereas Part 2 is a placebo-controlled, double-blinded, and randomized study to find the optimal dose of MIT-001 regarding the efficacy of OM and safety for the next IIb/III clinical trials. In Part 1, the total screening period was 28 days: conditioning chemotherapy/MIT-001 treatment for four to nine days followed by auto-HSCT and recovery for 14 days and discharge at 28 days following HSCT. MIT-001 was administered intravenously for 30 minutes once daily before conditioning chemotherapy for four to nine days, depending on the conditioning regimens including high-dose melphalan and BMT (intravenous busulfan, melphalan, thiotepa) for auto-HSCT. Pharmacokinetic blood samples of MIT-001 was collected at 5 time points including before administration to 24 hours after the start of the first and last administration of MIT-001. WHO criteria and NCI-CTCAE (v5.0) for OM grading were used for the severity of OM, which was evaluated daily during hospitalization and twice a week or once a week after discharge by investigator's choice. Pain related to OM was collected from patients using the Oral Mucositis Daily Questionnaire. Results: In part 1, total of sixteen patients were enrolled in which 5 patients were assigned in 5 mg and 20 mg group each, and six patients were assigned in the 10 mg group. Twelve lymphoma patients and four MM patients were pre-conditioned by BMT and Melphalan regimen, respectively. Severe OM (grade 3) were observed in two lymphoma patients treated with 10 mg and 20 mg MIT-001 (FAS: 13.3%, 2/16). Two patients with grade 3 OM had experienced radiation therapy of head and neck area within 1 year. Severe OM (> grade 3) did not occur in the four MM patients, while grade 2 was observed in two patients. None of the patients received total parental nutrition feeding due to OM. The median duration of grade 3 OM was 6 days (range, 3 to 9) and mean onset was 6 days (SD±1) after conditioning initiation. The duration and incidence of OM were not significantly different among the 3 groups. Mean area-under-the-curve (AUC) score for patient-reported soreness of the mouth and throat was not proportional to the dose of MIT-001. Time to engraftment was observed at a median time of 13 days (range, 11~ 26 days) determined by the neutrophil and platelet recovery time following auto-HSCT, which was within the normal range of period of auto-HSCT when compared to historical control. With the statistical analysis using the Kruskal-Wallis test, MIT-001 showed good PK profile with dose-proportionality in the range of 5 mg up to 20 mg. Two doses of 5 mg and 20 mg were determined as RP2D under steering committee. Serious adverse drug reactions were not reported. Part 2 is currently ongoing to evaluate efficacy of OM and safety of MIT-001 in forty-five patients with lymphoma and MM, where fifteen patients were allocated in 5 mg, 20 mg, and placebo group. Conclusions: The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT.

Psychometric evaluation of Oral Mucositis Daily Questionnaire: A cross-cultural adaptation of the Malay version in multiethnic adult autologous stem cell transplant

ObjectiveMucositis is one of the most feared side effects of cancer treatment. Psychometric analysis of a patient self-assessment score, the oral mucositis daily questionnaire in Malay (OMDQ-Mal) and its construct validity by means of confirmatory factor analysis (CFA) is lacking. This research aimed to test the validity and reliability of OMDQ-Mal. MethodsA total of 114 autologous stem-cell transplantation patients aged ≥ 18 years old at a national hematology center in Malaysia from April 2019 to December 2020 completed OMDQ-Mal concurrently with physician scores. Internal consistency and reproducibility were determined by Cronbach alpha and intraclass correlation coefficient, respectively. Correlations with physician scores were determined by Spearman correlation. Discriminative validity and construct validity were determined by Mann–Whitney U and CFA, respectively. ResultsOMDQ-Mal demonstrated high internal consistency (α ​= ​0.874). Test–retest reliability between paired days were moderate to excellent (95% CI ​= ​0.676–0.953). Items in OMDQ-Mal had moderate to strong correlations with physician scores (ρ ​= ​0.503–0.721). Discriminative validity indicated that the scores of scales were significantly different between participants with severe and mild conditions. Construct validity results of loading factors 0.708–0.952; composite reliability 0.879–0.974; average variant extracted 0.710–0.841; and heterotrait–monotrait ratio 0.528 established the convergent and divergent validity. ConclusionsIn conclusion, the OMDQ-Mal, which captured important quality of life responses, demonstrated adequate validity and reliability. This was supported by a two-component model CFA. The strong correlation of OMDQ-Mal with both physician scores indicated its potential as a comprehensive patient-reported outcome measure of mucositis of the entire alimentary tract.

Stem cell transplantation patients receiving a novel oral care protocol for oral mucositis prevention and treatment: patient-reported outcomes and quality of life

BackgroundOral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs).MethodData on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions.ResultsFifty-nine autologous/allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD ± 3.5) days after conditioning initiation, mean duration was 10.4 (SD ± 4.3) days, and the average maximum pain score was 3.7 (SD ± 2.7). Self-administration of the OMDQ detected oral symptoms at least 1 day sooner compared to objective assessments (p = 0.025). Significant differences were observed between the patient-reported and the HCP-assessment data on oral mucositis severity grading distribution (p < 0.0001) and highest pain score (p < 0.0001). Quality of life score variations were correlated with changes in oral mucositis severity during patients’ hospital stay.ConclusionsFurther studies are necessary to improve the understanding of these findings; a randomised controlled trial is being set up at our institution.

Validation of healthcare professional proxy-reported children's International Mucositis Evaluation Scale.

The objective was to describe the reliability and validity of the healthcare professional proxy-report version of the Children's International Mucositis Evaluation Scale (ChIMES). We included pediatric patients who were between 4 and 21years of age and scheduled to undergo hematopoietic cell transplantation. Mucositis was evaluated by trained healthcare professionals who scored ChIMES, the World Health Organization oral toxicity scale, mouth, and throat pain visual analogue scale, National Cancer Institute-Common Terminology Criteria and the Oral Mucositis Daily Questionnaire. Measures were completed daily and evaluated on days 7-17 post-stem cell infusion for this analysis. Psychometric properties examined were internal consistency, test-retest reliability (days 13 and 14), and convergent construct validity. There were 192 participants included. Cronbach's alpha was 0.90 for ChIMES Total Score and 0.93 for ChIMES Percentage Score. Test-retest reliability were as follows: intraclass correlation coefficient (ICC) 0.82 (95% confidence interval (CI) 0.77-0.85) for ChIMES Total Score and ICC 0.82 (95% CI 0.77-0.86) for ChIMES Percentage Score. In terms of construct validation, all correlations between measures met or exceeded those hypothesized (all p<0.05). The healthcare professional proxy-report version of ChIMES is reliable and valid for children and adolescents undergoing hematopoietic cell transplantation.

Efficacy and safety of Dentoxol\xae in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial

PurposeThe aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer.MethodsA randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed.ResultsThe incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events.ConclusionThe use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

Bilateral Elective Nodal Radiation Increases Narcotic Requirement But Not Patient-Reported Pain During Head and Neck Cancer Radioation Therapy

Oral mucositis occurs in the majority of patients (pts) undergoing radiation therapy (RT) for head and neck cancer (HNC). The Oral Mucositis Daily Questionnaire (OMDQ) is a validated survey for HNC patient pain. This analysis was undertaken to report the course of patient-reported pain and associated narcotic use throughout the duration of RT for pts with HNC. Hypothesis: We hypothesized pts with bilateral elective nodal RT (BL-RT) treatment vs. unilateral elective nodal RT (UL-RT), with or without concurrent chemotherapy (CRT), would have significantly worse pain that coincided with increasing narcotic requirement. Pts with Stage I-IV HNC who were treated with either adjuvant or definitive RT at our institution from 2015 to 2017 were included for analysis. At baseline and weekly on-treatment visits, clinical data including narcotic use was recorded and OMDQ was administered. Pain was treated with either our institution’s standard of care (SOC) analgesic regimen using hydrocodone-acetaminophen +/- transdermal fentanyl as needed, or according to an outside provider (OP). Average daily narcotic use was converted to oral morphine milligram equivalents and reported as a cumulative requirement (dMME). Pts were dichotomized by either unilateral or BL-RT and +/- concurrent chemotherapy (RT vs CRT). To evaluate Mouth/Throat Soreness (MTS) OMDQ score response, the difference between baseline and week 3 (W3D) and at end-of-treatment (EoTD) was calculated for each pt. All other elements of the OMDQ were also analyzed. Two way ANOVA was performed and associations over time were quantified with a random coefficient mixed model. A total of 98 patients were eligible for analysis (42% SOC and 59% OP). The median age was 61.2y (IQR: 55.4-70.1y). Median dose to the primary was 70Gy (Range:50-70Gy). Overall, pts were treated: 44% adjuvantly, 56% definitively, 56% BL-RT, 39% UL-RT, 82% CRT, 18% RT alone. SOC vs. OP had no change in weekly MTS and no significant difference in dMME. There was no difference in overall pain scores, W3D or EoTD when comparing elective nodal RT; however, there was increased narcotic requirement for BL-RT (p<0.001). CRT vs. RT-alone had greater weekly MTS (p=0.03) and an increased dMME (p=0.047). There were no significant differences in all other OMDQ questions. We report on the use of narcotics and mucositis-related pain throughout the course of RT. Surprisingly, BL-RT did not increase MTS scores compared to UL-RT. Not surprisingly, CRT did increase weekly MTS scores. Both BL-RT and CRT increased narcotic requirements. Implications for research: This study suggests that narcotic use as measured by dMME, rather than OMDQ, may be a better metric for quantifying mucositis during radiation.

Prophylactic Gabapentin Combined with Methadone Improves Overall Health in Patients Undergoing Chemoradiation for Head and Neck Cancer While Reducing Use of Opioids with High Abuse Potential: Early Results of a Prospective Randomized Trial

Oral mucositis occurs in the majority of patients (pts) undergoing chemoradiation therapy (CRT) for head and neck cancer (HNC). The Oral Mucositis Daily Questionnaire (OMDQ) is a validated survey for HNC patient pain. Gabapentin (GABA) has been used concurrently with opioids to improve pain control in pts with HNC. Methadone (MTD) is a low abuse potential opioid that is used for neuropathic pain. This single center prospective randomized study was undertaken to compare analgesia regimens for pts undergoing CRT. Hypothesis: We hypothesized pts treated with GABA would have improved pain control and delay the onset of narcotic requirement, and the addition of MTD would provide improved pain control. Pts with Stage II-IV HNC who were treated with definitive CRT were randomized to one of two pain regimens: 1) High-dose GABA (900mg TID) with hydrocodone-acetaminophen followed by transdermal fentanyl as needed (HD-HAF) or 2) Low-dose GABA (300mg TID) with methadone (5-15mg BID) and oxycodone as needed (LD-MTD). Pts were stratified by bilateral or unilateral radiation. At baseline and weekly on-treatment visits, clinical data including narcotic use was recorded and OMDQ was administered. Average daily narcotic use was converted to oral morphine milligram equivalents. Two sided T and Fischer exact tests were performed. A total of 60 pts were randomized; at the time of analysis not all patients had completed their scheduled evaluations. Median dose to the primary was 70 Gy. There were no attributable grade 3 adverse events. Approximately half of HD-HAF and three quarters of LD-MTD required a narcotic during CRT. The time to first narcotic was approximately 4.5 weeks for both groups. LD-MTD had better Overall Health at week 7 vs. HD-HAF (p<0.05). This study demonstrates that both pain regimens are safe and well tolerated. Methadone is associated with better overall health at the end of treatment for pts undergoing CRT. Our next study will utilize high dose GABA and methadone. Implications for practice or research: Methadone, as a low abuse potential narcotic, combined with prophylactic GABA can improve overall health at the end of CRT for HNC. Further escalating GABA dose may optimize the therapeutic benefit of MTD and will be tested in a future study.

The Children's International Mucositis Evaluation Scale Is Valid and Reliable for the Assessment of Mucositis Among Brazilian Children With Cancer

BackgroundThe Children's International Mucositis Evaluation Scale (ChIMES) is considered a valid and reliable instrument for the assessment of mucositis in pediatric patients aged 0–18 years. ObjectiveTo perform the translation and cultural adaptation of ChIMES to Brazilian Portuguese and assess its psychometric properties. MethodsMethods for translation and cultural adaptation were used. Other measurements obtained concomitantly for the assessment of psychometric properties included the Oral Mucositis Daily Questionnaire, a visual analog scale, the World Health Organization grading scale for mucositis, and the National Cancer Institute Common Terminology Criteria for Adverse Events toxicity scale. For test-retest analysis, patients and guardians responded to the self-report and proxy versions of ChIMES within intervals of one to seven days. ResultsRegarding internal consistency, Cronbach's alpha (α) values were 0.769 (95% CI = 0.631–0.868) and 0.879 (95% CI = 0.872–0.920) for the self-reported and proxy versions, respectively. The convergent validity criteria were met for the self-reported and proxy versions (Spearman's rho = 0.466–0.751; P < 0.001 and Spearman's rho = 0.410–0.551; P < 0.001, respectively). Test-retest reliability assessment for the total score and Items 1, 2, 3, and 4 in both versions showed an intraclass correlation coefficient of ≥0.7. ConclusionsThe Portuguese self-reported and proxy versions of ChIMES were considered to be culturally adapted, valid, and reliable for Brazilian pediatric patients ranging from an age of one month to 18 years and were named ChIMES-BR.

Measuring oral mucositis of pediatric patients with cancer: A psychometric evaluation of chinese version of the oral mucositis daily questionnaire

Objective:Oral mucositis is a frequent clinical condition that has been shown to affect pediatric cancer patients. Oral Mucositis Daily Questionnaire (OMDQ) is one of the few available patient-reported outcome measures to assess the extent and impact of oral mucositis. The objectives of the study were to translate the Mouth and Throat Soreness-Related Questions of the OMDQ into Chinese (OMDQ MTS-Ch) for children and adolescents aged 6–18 years receiving chemotherapy and to evaluate its psychometric properties.Methods:This was part of a multicenter, prospective cohort study involving two phases. Phase I involved forward-backward translation to fit the cognitive and linguistic age level of the children and adolescents, followed by face and content validation, together with pretesting. In Phase II, which evaluated the internal consistency, test-retest reliability, and discriminant validity, a total of 140 patients completed the OMDQ MTS-Ch for 14 days.Results:The OMDQ MTS-Ch had satisfactory face and content validities. The Cronbach's alpha coefficient of the OMDQ MTS-Ch was 0.984. All of the corrected item-total correlations were higher than 0.90. The test-retest intraclass correlation coefficient between consecutive days for the OMDQ MTS-Ch items ranged from 0.576 to 0.983; the only value that was not over 0.70 was that for the paired study days 7 and 8 for the item of talking. The mean area-under-the-curve OMDQ MTS-Ch item scores were significantly different among patients with different degrees of mucositis severity (P < 0.001), supporting the discriminant validity.Conclusions:It has been shown that the OMDQ MTS-Ch has a good level of reliability and discriminant validity and can be completed by children aged ≥6 years and adolescents on a daily basis to measure mucositis and its related functional limitations.

Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated. A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques. Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life. A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials.

Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation

Background:The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning, reduces the duration of severe oral mucositis (OM) compared with placebo among children and adolescents undergoing haematopoietic cell transplantation (HCT).Methods:This was a Children’s Oncology Group multicentre randomised double-blinded placebo-controlled clinical trial. Patients between the ages of 4 and 21 years who were scheduled to undergo myeloablative HCT for any indication were randomised to Caphosol or placebo saline rinses four times daily from initiation of conditioning through day +20. Subjects were assessed daily for OM using the World Health Organisation (WHO) Oral Toxicity Scale, Mouth Pain Categorical Scale (0–10) and the Oral Mucositis Daily Questionnaire (OMDQ). The primary end point was duration of severe OM (WHO ⩾3).Results:The study enrolled 220 participants with a median age of 13.7 years (range 4.0–21.9); 163 (74%) received allogeneic HCT. The mean (±s.d.) duration of severe OM was not reduced among Caphosol (4.5±5.0 days) vs placebo (4.5±4.8; P=0.99) recipients. The incidence of severe OM in the Caphosol and placebo arms was 63% (57 out of 91) and 68% (62 out of 91), respectively (P=0.44). There were no significant differences in any of the secondary end points between the groups.Conclusions:Caphosol did not reduce severe OM when compared with placebo among children and adolescents undergoing myeloablative HCT. Studies to identify effective interventions for OM are needed in this population.

Abstract CT122: RCT of an herbal mouthrinse for radiotherapy induced oral mucositis in cancer patients

Abstract Objectives: Primary aim of the ongoing study (NCT01898091) is to determine whether a mouthrinse containing extract of neem leaf (Azadirachta indica A. Juss.), a tropical evergreen tree with anti-inflammatory and anti-microbial medicinal properties, will lessen the severity of oral mucositis (OM) in patients undergoing radiation therapy (RT) to the head and neck. Secondary aims are to assess the effects of the neem mouthrinse on the microbial environment of the oral cavity and on quality of life. Methods: Design is a double-blind, controlled, randomized, parallel-group Phase II clinical trial at a single NCI designated center. Block-randomization was used for patient assignment, stratified by tobacco use. Eligibles were adults with histologically confirmed head and neck cancer (HNC) whose treatment includes RT for 7 weeks. HNC includes malignancy of the oral cavity, oro-pharynx and larynx (ICD-9 codes 140 - 149, 161; ICD-O morphology code of 2 or 3). Exclusion criteria include prior HNC radiotherapy, baseline mouth and throat soreness (MTS) score of &amp;gt;3, ECOG performance status &amp;gt;2, allergy or inability to use mouthrinse, and language barrier. Evaluable participants receive &amp;gt; 40 Gy RT and participate to week 6 RT. Study duration is 12 weeks with visits at baseline, weekly during RT, 3 telephone visits post RT, and one-month follow-up visit. Data were collected using the Oral Mucositis Daily Questionnaire, Functional Assessment of Cancer Therapy-Head and Neck, and Symptom Distress Scale questionnaires; CariScreen for oral microbial load, and ELISA and flow cytometry for salivary analyte measures. Results: Of 53 patients enrolled, 3 screen failed and 8 withdrew leaving 42 with evaluable data. Neem (n = 23) and placebo (n = 19) groups were not statistically different for demographic and clinical variables. Major hypothesis assessed as the maximum change in MTS score from baseline during 6 weeks of RT resulted in a larger change, 1.91 with SD 1.34 for neem group vs. 1.71 with SD 1.29 for placebo group based on a Wilcoxon rank sum test with one-sided alpha = 0.05. Preliminary results suggest no difference in the maximum change in severity from baseline (p = 0.85). Neem group had higher adherence to mouthrinse protocol measured as ≥4 days mouthrinse use per week for six weeks (OR 2.56, p = 0.19). Additional outcomes of ongoing comparisons across groups include time to maximum OM severity, time to onset of OM, percent of patients with MTS scores &amp;lt;3, and percent of patients by levels of change in MTS score. Regression analyses will be used to assess relationships between maximum and temporal changes in MTS score and mouthrinse group, adjusted for baseline characteristics and pertinent events. Relationships between changes in MTS score and mouthrinse usage over the time-course of the study will also be explored by graphical comparisons and regression approaches. Time to event outcomes will be assessed using Kaplan-Meier curves and comparisons will be made by log rank tests. Due to sample size, these latter analyses will be exploratory. Citation Format: Susan G. Reed, Joan E. Cunningham, Elizabeth Garrett-Mayer, Jennifer L. Mulligan, Laura D. Fields, Lynsey R. Boyle, Sarah P. Daanen, John H. Keller, Casey L. Roach, Whitney C. Pasquini, Lauren Lawrence, Howell Harmon, Ahmad R. Garrett, Michael J. Wargovich, Anand K. Sharma. RCT of an herbal mouthrinse for radiotherapy induced oral mucositis in cancer patients. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr CT122. doi:10.1158/1538-7445.AM2015-CT122

Risk and outcomes of chemotherapy-induced diarrhea (CID) among patients with colorectal cancer receiving multi-cycle chemotherapy.

Diarrhea is a common toxicity of chemotherapy, but the practice of reporting only severe grades (≥ 3) in clinical trials results in misleading conclusions of significance. Epidemiology remains poorly described, and effects of multi-cycle regimens have not been investigated. To better understand the risks, symptom burden and consequences of CID, we studied patients receiving chemotherapy for colorectal cancer (CRC). One hundred and fourteen patients receiving FOLFOX (95 patients, 530 cycles), FOLFOX + monoclonal antibodies (10 patients, 49 cycles) or FOLFIRI (9 patients, 50 cycles) were enrolled. CID was identified from diaries at baseline and daily during up to 8 chemotherapy cycles using supplemental questions on the Oral Mucositis Daily Questionnaire, a valid tool for collecting patient-reported outcomes of regimen-related mucosal injury. Patients scored CID severity from 0 "none" to 10 "worst possible," and quantity from "little" to "severe" on a 5-point scale. Quality of life was measured using the FACT-G, and fatigue using the FACIT fatigue scale. CID occurred in 89% of patients on FOLFIRI, 50% on FOLFOX + monoclonal antibodies and 56% on FOLFOX alone. The risk of a first episode was highest during Cycle 1 (35 %) and dropped to <10% during Cycles 3-5. Patients with CID reported poorer quality of life scores than those without CID (77.1 vs 80.7). Diarrhea occurs more commonly than typically appreciated during chemotherapy for CRC. Risk is highest during first exposure, suggesting variable susceptibility. Identification of this high-risk subgroup for prophylaxis could improve the quality of life.

Mucositis care in acute leukemia and non-Hodgkin lymphoma patients undergoing high-dose chemotherapy.

This study intends to provide new insights into the incidence and care of mucositis by the epidemiological characterization of patients with hematological malignancy treated at our institution. It also aims to understand the effectiveness of several treatments used. This is a longitudinal observational single-center study-convenience sample-which includes malignant hematologic inpatients submitted to high-dose CT from February to August 2012. We registered epidemiological data, diagnosis, oral mucositis daily questionnaire (OMDQ), World Health Organization (WHO) oral toxicity scale, and supportive medications used for mucositis. We evaluated 30 patients who had 73 episodes of hospitalization, having recorded the development of mucositis in 21.9% (n = 16) episodes (22 patients with acute leukemia (AL) and 8 patients with non-Hodgkin lymphoma (NHL)). Grades 3-4 mucositis was reported in 4.1% of the total episodes. The results of OMDQ showed some limitations in the quality of life, of patients with mucositis, related with the ability to eat and drink due to mouth pain (p < 0.001). In patients with NHL and AL, neutropenia entails an increased risk of mucositis (p < 0.001). Patients who did not initiate early prophylaxis with conservative measures developed mucositis earlier (p < 0.05). The incidence of mucositis is high, being reported mainly in AL patients, with limitations in quality of life. Grade 4 neutropenia increases mucositis risk. Early prophylaxis with basic oral care may delay mucositis. Further studies are crucial to characterize mucositis epidemiology, physiopathology, and its management.

Multi‐institutional, randomized, double‐blind, placebo‐controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck

In a randomized, double‐blind, placebo‐controlled trial, the mucoadhesive hydrogel MuGard proved to be superior to saline‐bicarbonate rinse in mitigating oral mucositis (OM) symptoms and delaying OM progression. MuGard was safe and well‐tolerated, and favorably affected the rate and incidence of ulcerative lesions, consistent with the patient‐reported outcomes.

Impact of oral mucositis on short-term clinical outcomes in paediatric and adolescent patients undergoing chemotherapy

The purpose of this study is to determine the burden of the peak severity of oral mucositis and severity over time on selected clinical outcomes in paediatric and adolescent patients receiving chemotherapy. A multicentre study enrolled 140 patients between the ages of 6 and 18 years, who had been treated with chemotherapy and completed the self-report Mouth and Throat Soreness-related questions of the Oral Mucositis Daily Questionnaire for 14 days. Clinical data were collected from patients' medical records during the first 14 days after starting chemotherapy. Forty-one percent developed oral mucositis. Multiple linear regression analysis revealed that oral mucositis was significantly associated with an increased loss of baseline body weight, after controlling for nausea/vomiting (β = 0.34, p = 0.002). Multiple logistic regression analysis showed that severe mucositis was significantly associated with a higher probability of fluid replacement, after controlling for nausea/vomiting (adjusted OR = 12.8; 95 % CI = 2.7-61.0; p = 0.001). In addition, severe mucositis was significantly associated with a higher probability of fever, after controlling for neutropoenia (adjusted OR = 5.4; 95 % CI = 1.8-15.4; p = 0.002). No difference was observed for oral or systemic infections among the subgroups. About 5 % of the patients with oral mucositis had delays in chemotherapy (≤ 7 days). None of the patients had dose modification or unplanned hospitalization due to oral mucositis. The associations of peak severity and overall oral mucositis with adverse clinical outcomes in paediatric and adolescent patients were equivalent. Oral mucositis is associated with negative effects on clinical outcomes.

Difference of Oral Mucositis in Hospitalized Cancer Patients Receiving Chemotherapy

Purpose: This study was designed to investigate the difference of oral mucositis in hospitalized cancer patients receiving chemotherapy according to characteristics. Methods: Data were collected from March 1 to April 25 2012 using questionnaires, and the participants were 177. The Oral Assessment Guide (OAG) by observation and The Oral Mucositis Daily Questionnaire (OMDQ) by selfreport were used to measure oral mucositis. The data were analyzed using SPSS 18.0. Results: Moderate to severe oral mucositis measured by OAG observation were 94.9% in hospitalized cancer patients receiving chemotherapy, frequently complaints of mouth and throat soreness measured by OMDQ was 42.4%, and intensity of mouth and throat soreness measured by OMDQ was 0.65 out of 10. There were statistically significant differences in the prevalence of oral mucositis according to nutrition state, frequency of chemotherapy, experience of oral examination, combination treatment, and number of chemotherapeutic agents. Conclusion: Many hospitalized cancer patients receiving chemotherapy experienced oral mucositis. Cancer patients receiving chemotherapy with poor nutritional status, more frequent chemotherapy and combination treatments should have a more meticulous oral care. So there needs to be an appropriate assessment tool and prevention protocol for oral mucositis that considers related factors.

In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient’s burden

This randomized-controlled trial studied the efficacy of palifermin in a chemotherapy-only, high-dose Melphalan (HDM) transplant setting, to reduce oral mucositis (OM) and its sequelae measured by patient-reported outcomes (PRO) and medical resource use. Palifermin, relative to placebo was given either pre-/post-HDM or pre-HDM in patients with multiple myeloma (MM) undergoing auto-SCT at 39 European centers. Oral cavity assessment (WHO) and PRO questionnaires (oral mucositis daily questionnaire (OMDQ) and EQ 5D) were used in 281 patients (mean age 56, ± s.d.=8 years). 57 patients received placebo. One hundred and fifteen subjects were randomized to pre-/post-HDM receiving palifermin on 3 consecutive days before HDM and after auto-SCT and 109 patients were randomized to pre-HDM, receiving palifermin (60 μg/kg/day) i.v. for 3 consecutive days before HDM. There was no statistically significant difference in maximum OM severity. Severe OM occurred in 37% (placebo), 38% (pre-/post-HDM) and 24% (pre-HDM) of patients. No significant difference was observed with respect to PRO assessments or medical resource use, but more infections and fever during neutropenia were reported in pre-/post-HDM vs placebo (for example, 51 and 26%). To conclude, palifermin was unable to reduce OM or OM-related patient's burden in MM transplant patients.

Sodium Bicarbonate Solution versus Chlorhexidine Mouthwash in Oral Care of Acute Leukemia Patients Undergoing Induction Chemotherapy: A Randomized Controlled Trial

The objective of this study was to compare the effectiveness of sodium bicarbonate (SB) solution with chlorhexidine (CHX) mouthwash in oral care of acute leukemia patients under induction chemotherapy. Forty-eight patients were randomly selected and assigned to an SB solution group or CHX-based product group according to acute myelogenous leukemia or acute lymphoblastic leukemia. Patients were asked to rinse their mouth four times a day from the day before chemotherapy started until discharge. The World Health Organization mucositis grade, patient-reported Oral Mucositis Daily Questionnaire, and clinical signs associated with infection were assessed on a daily basis. The oral microbial count was assessed on a weekly basis from the 1st day of chemotherapy started to the 28th day or to the day of discharge from the hospital. Of all the patients in the SB group, 25.0% developed ulcerative oral mucositis, whereas 62.5% in the CHX group did. The onset of oral mucositis was later in the SB group than the CHX group. The oral bacterial colonization in the SB group was significantly higher than that in the CHX group, but clinical signs associated with infection did not differ in both groups. As a result of this study, it was found that oral care by SB solution for acute leukemia patients undergoing chemotherapy was an effective intervention to improve oral health.