Evaluation Of Mucositis Research Articles

Oral mucositis assessment in pediatric and adolescent oncological patients: A systematic review.

Oral mucositis (OM) is a prevalent acute adverse effect of various cancer treatments. Accurate assessment of OM is vital for effective prevention and treatment strategies. However, a lack of validated pediatric instruments for evaluating OM can lead to unreliable data, and hinder interventional and epidemiological research. This study aims to evaluate the methods used for assessing OM in pediatric oncology patients. A systematic review of four databases and a manual search yielded 113 articles. Nine different scales were identified, with the World Health Organization (WHO) scale being the most commonly used (61.9%). The Children's International Mucositis Evaluation Scale (ChIMES) was used in 7.9% of the studies. Of the 8155 pediatric patients evaluated, 47.7% had both hematological malignancies and malignant solid tumors, while 46% had solely hematological malignancies. Despite the prevalence of the WHO scale, it lacks pediatric-specific criteria. Future OM research should incorporate validated tools like ChIMES for improved pediatric assessment.

Abstract 4192: In-depth evaluation of chemotherapy-induced mucositis in intestinal organoids using holotomography

Abstract Intestinal mucositis is a prevalent adverse event associated with antineoplastic therapies, such as chemotherapy, which still lacks a targeted and effective treatment regimen. The difficulty in preclinical prediction and prevention of drug-induced intestinal mucositis is attributed to the intricate underlying mechanisms of its onset and the broad spectrum of patient-specific responses to chemotherapeutic agents. Advancements in regenerative medicine have enabled the generation of intestinal organoids from adult stem cells, serving as a personalized model to emulate disease pathology and simulate individual drug responses. Various imaging techniques are employed to evaluate the responses of the organoids to pharmacological agents, but the inherent complexity of their three-dimensional (3D) architecture poses significant challenges in organoid imaging. These challenges are exacerbated by the standard preparation processes for imaging, including fixation and staining, which do not allow for the observation of dynamic, real-time effects of drugs on living organoids. In this study, we focused on meticulously examining the histopathological alterations in small intestinal organoids subjected to chemotherapeutic agents that induce mucositis, specifically 5-fluorouracil and irinotecan. Employing holotomography, a label-free real-time 3D imaging technology, we were able to visualize the destructive processes affecting the intestinal organoids, including the breakdown of the epithelial lining, the exfoliation of dead cells, and the alteration of the villus/crypt structure. Furthermore, we propose a novel methodology for quantifying the viability of intestinal organoids. This quantification is essential for assessing the extent of damage caused by the chemotherapeutic agents and for determining the maximum drug concentrations that can be deemed safe for use, thereby minimizing the risk of inducing mucositis while maintaining therapeutic efficacy. These results provide new insights into the toxic mechanisms of chemotherapeutic drugs and highlight the importance of using organoid models in drug safety evaluation throughout the development phase. Citation Format: Mahn Jae Lee, Jaehyeok Lee, Weisun Park, Geon Kim, Hye-Jin Kim, YongKeun Park. In-depth evaluation of chemotherapy-induced mucositis in intestinal organoids using holotomography [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4192.

Depressive symptoms and oral mucositis in children with oncological diseases: a cross-sectional study.

The aim of this study was to investigate the correlation between depressive symptoms and the occurrence of oral mucositis in children with oncological diseases treated at a reference hospital. This was a cross-sectional study conducted with individuals aged 4 to 18 years, diagnosed with primary neoplasms. Data was collected by using a questionnaire that assessed the degree of oral mucositis according to the World Health Organization index, the risk of oral mucositis according to the Child's International Mucositis Evaluation Scale, and depressive symptoms using the Children's Depression Inventory. The data were analyzed and subjected to Spearman's correlation, chi-square test, and Fisher's exact test, considering p<0.05. A statistically significant correlation was observed between depressive symptoms and the degree of oral mucositis (p = 0.044), and also between the "pain" variable within the risk of oral mucositis and depressive symptoms (p = 0.021). Based on the findings, it can be inferred that oral mucositis may be associated with the development of depressive symptoms and may be influenced by the individual's hospitalization, thereby affecting the quality of life of pediatric patients.

Comparative evaluation of oral mucositis in oral cancer patients undergoing 3-dimensional conformal radiation therapy and intensity modulated radiation therapy with or without chemotherapy.

Oral cancer is a significant cause of death across the world. A combined multimodal approach integrating surgery and radiation therapy (RT) with or without chemotherapy (CT) is commonly employed in advanced oral cancer to prevent recurrences and locoregional spread. Oral mucositis is a common acute toxicity reported in patients undergoing RT and CT. The delivery of optimal cancer therapy protocols is compromised due to morbidity caused by oral mucositis. To compare the severity of oral mucositis in oral cancer patients undergoing 3-Dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT) with or without concomitant CT. This was a prospective, unicentric and longitudinal study conducted in a cancer centre. One hundred four patients with locally advanced oral cancer were enrolled in this study. Fifty-two patients were treated with IMRT and 52 patients with 3DCRT to a dose of >60 Gy, along with concurrent cisplatin weekly CT. Mucositis was recorded before the start, in the end, 1 month, and 3 months post-chemoradiotherapy treatment. Statistical analysis was performed using Statistical Package for Social Sciences (SPSS) software (v. 21.0, Chicago. 2012). Descriptive and frequency statistics were performed for different parameters assessed in 3DCRT and IMRT group. Grade 3 mucositis was the most predominant grade observed in both groups at the end of treatment. Thirty-six patients (69.3%) versus 24 patients (46.1%) developed grade 3 mucositis in 3DCRT and IMRT group, respectively (P = 0.013). Healing was better with IMRT group when compared to 3DCRT group 1 month and 3 months post-RT. Mucositis was severe in patients undergoing concomitant CT. IMRT reduced the incidence of severe mucositis and also improved the treatment-compliance compared to 3DCRT in locally advanced head neck cancer patients treated by chemoradiotherapy.

Patient-reported oral mucositis in solid tumour patients undergoing chemotherapy: a Ugandan experience.

The mitotic rate of the gastrointestinal tract (GIT) mucosa predisposes the entire system to chemotherapeutic-induced mucositis but the oral cavity due to its accessibility provides an opening to evaluate the extent of the problem much more easily. In addition, the oral cavity being the gateway to the GIT affects the feeding ability of the patient when the ulcers set in.It is therefore from this perspective that we embarked on a study to evaluate the extent of mucositis among patients being treated for solid tumours at our centre. Using the mouth and throat soreness (OMDQ MTS) questionnaire, we prospectively evaluated mucositis among 100 patients undergoing chemotherapy for solid tumours at the Uganda Cancer Institute. In addition to patient reported outcomes, we also had clinician assessed mucositis measurements. Approximately, 50% of the participants were breast cancer patients. The results demonstrated that patient assessment of mucositis is possible in our setting at a 76% full compliance rate. Up to 30% of our patients reported moderate-to-severe mucositis, though the figure was lower as assessed by the clinicians. The self-reported OMDQ MTS can be useful in our setting for daily mucositis evaluation, hence leading to timely hospital visits before the manifestation of severe complications.

Evaluation of oral mucositis, candidiasis, and quality of life in patients with head and neck cancer treated with a hypofractionated or conventional radiotherapy protocol: a longitudinal, prospective, observational study

BackgroundDue to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, recently, Radiotherapy (RT) protocols requiring fewer sessions (hypofractionated) have been used to shorten RT treatment and minimize patient exposure to medical centers, and decrease the risk of SARS-CoV-2 infection.MethodsThis longitudinal, prospective, observational study aimed to compare the quality of life (QoL) and the incidence of oral mucositis and candidiasis in 66 patients with head and neck cancer (HNC) who undergo a hypofractionated RT protocol (GHipo), total of 55 Gy for 4 weeks, or a conventional RT protocol (GConv), total of 66 − 70 Gy for 6 − 7 weeks.PurposeTo assess the incidence and severity of oral mucositis, the incidence of candidiasis, and QoL were evaluated using the World Health Organization scale, clinical evaluation, and the QLC-30 and H&N-35 questionnaires, respectively, at the beginning and the end of RT.ResultsThe incidence of candidiasis did not show differences between the two groups. However, at the end of RT, mucositis had a higher incidence (p < 0.01) and severity (p < 0.05) in GHipo. QoL was not markedly different between the two groups. Although mucositis worsened in patients treated with hypofractionated RT, QoL did not worsen for patients on this regimen.ConclusionsOur results open perspectives for the potential use of RT protocols for HNC with fewer sessions in conditions that require faster, cheaper, and more practical treatments.

Evaluation of GVHD And oral mucositis in patients submitted to HSCT at the STMO-CHC of UFPR

Evaluation of GVHD And oral mucositis in patients submitted to HSCT at the STMO-CHC of UFPR

ORAL MUCOSITIS IN CHILDREN WITH CANCER: DIFFICULTIES OF EVALUATION AND EFFECTIVE THERAPY

<h3>Objectives</h3> Cancer is a world public health problem, and the incidence in children increase is 1% per year. Despite its high efficacy, antineoplastic therapy induces effects of significant toxicity, often causing patient hospitalization, difficulties in continuing oncotherapy or noncontinuation of adequate treatment for nonprogression of the disease. Oral mucositis is one of the most common deleterious effects; it causes pain, affects speech and nutrition, and makes the patient susceptible to septicemia. In children, the frequency of oral mucositis is around 65%, and its manifestations are evaluated with different scales and treated with different protocols. The objective of this work is to verify the state of the art of the assessment of oral mucositis in children undergoing cancer treatment, with regard to the criteria. <h3>Study Design</h3> A systematic review was performed. <h3>Results</h3> Studies have shown that evaluation is essential to establish treatment strategies, whereas the protocols and scales used are inconsistent, and there is no viable and valid system for punctuating childhood mucositis caused by cancer, preventing a more effective therapeutic intervention. <h3>Conclusions</h3> The Children's International Mucositis Evaluation Scale, created in 2009, has been the scale of greatest acceptability and validity.

The Flavonoid Troxerutin Prevents Tissue Damage and the Alteration of Cellularity Residing in Intestinal Mucositis by 5‐Fluorouracil

Intestinal mucositis, characterized by inflammatory and/or ulcerative processes, occurs due to cellular and tissue damage following treatment with 5‐fluorouracil (5‐FU). Troxerutin (TRX), a semi‐synthetic flavonoid extracted from Dimorphandra gardneriana, has been reported as a potent anti‐inflammatory agent. The present study aimed to evaluate the effect of TRX on 5‐fluorouracil‐induced intestinal mucositis in Swiss mice. The mice (25‐30g) were separated into 3 groups (n = 6): Saline group (NaCl 0.9%), 5‐FU group, TRX group (100mg/kg TRX, orally). All animals, except the Saline group, received 5‐FU at the concentration of 450 mg/kg in the first experimental protocol. Duodenal portions were removed for evaluation of mucositis by analysis of histopathological damage and cellularity of resident cells of the intestinal mucosa (mast cells and goblet cells). The results of the histopathological analysis demonstrated that 5‐FU promoted structural alterations of the intestinal mucosa (p &lt;0.05), evidenced by the reduction of villi height, deepening of the crypts, and TRX treatment (100 mg/kg) prevented the 5‐FU‐induced histopathological changes (p &lt;0.05). Regarding cellularity, TRX decreases 5‐FU‐induced mast cell infiltration (p &lt;0.05), as well as decreases cell lineage degranulation and, regarding goblet cell count, mucus‐producing cells, TRX prevented the decrease of these cells (p &lt;0.05), which is a problem promoted by the 5‐FU. Our findings suggest that TRX at a concentration of 100 mg/kg had chemopreventive effects on 5‐FU‐induced intestinal mucositis due to the prevention of histological damage and maintenance of resident cellularity in the intestinal mucosa.

Factors Associated With Oral Mucositis Severity in Children Who Have Received Chemotherapy.

Oral mucositis (OM) is a major complication for pediatric oncology patients undergoing cancer therapy. This paper aimed to report on the relationship between OM severity and various patient factors as well as to compare 2 scales used to assess OM severity. The severity of 68 separate episodes of OM in 47 pediatric oncology patients who had received chemotherapy was regularly assessed using the Children's International Mucositis Evaluation Scale (ChIMES) and World Health Organization (WHO) scale. The mean time from the start of the patients' chemotherapy block to the onset of OM was 8.4 days (±4.0), the median duration of OM was 7.0 days (4.0, 10.5) and median admission duration was 7.0 days (4.5, 13.5). There was a significant relationship between the severity of OM and the duration of symptoms ( P <0.001), patient's admission length ( P <0.001) and low neutrophil count. With decreasing neutrophil count, the severity of OM and number of pain medications used increased. Neutrophil count recovery coincided with resolution of OM. No significant relationship was found between OM severity and the child's cancer diagnosis. The 2 scales used to measure OM severity showed substantial agreement.

Evaluation of oral mucositis in pediatric cancer patients in Hiwa Hospital in Sulaymaniyah city, Kurdistan Region, Iraq

Background and objective: Oral mucositis is caused by the destruction of the oral mucosal epithelium and suppression of its growth secondary to antineoplastic treatment in the form of chemotherapeutic drugs, substances, or radiotherapy. This study aimed to evaluate oral mucositis in pediatric cancer patients because it is one of the common side effects of cancer therapy that influences the outcome. Methods: This is a cross-sectional study that enrolled 100 pediatric patients with both hematological and non-hematological cancer. The age of the patients ranged from 1-18 years, involving both genders. Cases admitted to Hiwa hospital were clinically evaluated for oral mucositis, and ethical permission was taken from parents. Risk factors were assessed, including age, sex, cancer type, type of chemotherapy, radiotherapy, number of cycles, complete blood count, interleukin-1 beta, interleukin-6, tumor necrosis factor-alpha, and tumor necrosis factor-beta. Results: Baseline serum cytokines levels showed significant correlation between Interleukin-6 and intensity of the oral mucositis (P = 0.003, rho = 0.314) and no correlation between severity of oral mucositis with tumor necrosis factor-alpha, tumor necrosis factor-beta nor interleukin-1 beta (P = 0.140 and rho = 0.258, P = 0.463 and rho = -0.079, and P = 0.706 and rho = -0.041, respectively). There was significant relationship between Hemoglobin level, neutropenia and type of non-hematological cancer with the intensity of oral mucositis respectively (P ≤0.001 and rho = -0.352, P = 0.027 and rho = -0.221, and P = 0.035 and rho = 0.095, respectively). Correlation between age, gender, white blood cell count, platelet count, type of hematological malignancy and past history with the intensity of the oral mucositis did not show significant result. Conclusion: Intensity of oral mucositis increased with anemia, neutropenia, high interleukin-6 level, and the type of non-hematological cancer. It is recommended to treat anemic, neutropenic patients as soon as possible before exacerbating the mucositis. Methotrexate is the most aggressive drug alone and in combined chemotherapy agents, which may cause mucositis and needs prophylaxis like topical nystatin suspension or other methods. Keywords: Oral mucositis; Pediatric cancer; Non-hematological; Hematological; Sulaymaniyah.

A real-world accuracy of oral mucositis grading in patients undergoing hematopoietic stem cell transplantation.

Oral mucositis is a common complication in patients undergoing hematopoietic stem cell transplantation. Accurate oral mucositis grading is essential for both clinical practice and oral mucositis research. This study aimed to evaluate the accuracy of daily oral mucositis grading by nurses in a tertiary hospital in Australia. A retrospective study was undertaken to review the daily patient oral assessment record, including diet, pain, erythema, ulceration and the oral mucositis grade based on World Health Organization (WHO) oral mucositis grading scale. The accuracy of the grade was determined by the observations recorded, and reasons for inaccuracy were documented. Any repetition of the same error in the same patient was noted. In total, 6841 oral assessments in 373 patients, conducted between 2017 and 2020, were reviewed. A total of 70% (N = 4781) were graded correctly. Of these, 64% (N = 3043) were grade 0. When the grade 0 scores were excluded, the accuracy of grading was reduced to 46% (N = 1738). Common reasons for incorrect grading included: unable to grade due to diet not specified, no ulceration and no pain was scored grade 1, no ulceration was scored as grade 2-4, oral intake was not taken into account, and pain without ulcer was scored 0. A total of 77% of the errors were repeated in the same patient on consecutive days. Our results suggest there is frequent inaccurate evaluation of oral mucositis and a need for nurse training to accurately assess oral mucositis.

Development and Validation of the Oral Mucositis Risk Assessment Scale in Hematology Patients.

This study was conducted as a methodological study to develop a valid and reliable scale to evaluate the risk of developing oral mucositis in hematology patients. The universe and sample were comprised of one hundred eighty-seven in-patients who were taken to receive chemotherapy in the hematology clinics over a six-month period. The data were collected through the Patient Diagnosis Form, the World Health Organization's Mucositis Evaluation Form and Oral Mucositis Risk Assessment Scale in Hematology Patients developed. Risk of "taking high-dose chemotherapy regimen", "neutropenia", "dry mouth", "pain", "leukopenia", "parenteral feeding", "previous history of oral mucositis" and "chemotherapy or radiotherapy in the past" were found as an oral mucositis risk factor. We have added "using high-risk chemotherapeutic agents", "bone marrow transplant", " head-neck or mouth cancer" which we consider clinically important. The scale consists of 11 items. The sensitivity value is 0.941 and the selectivity value is 0.724. We recommend that use the Oral Mucositis Risk Assessment Scale in Hematology Patients. Similar studies should be performed in oncology clinics and especially in patients receiving head and neck, oral radiotherapy. Oral mucositis is an important problem for hematology patients. nurses' risk assessment and early intervention to oral mucositis prevent the formation and complications of oral mucositis.

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.

Concordance of the WHO, RTOG, and CTCAE v4.0 grading scales for the evaluation of oral mucositis associated with chemoradiation therapy for the treatment of oral and oropharyngeal cancers.

The ability to consistently and accurately assess oral mucositis (OM) is critical to descriptions of its incidence and severity and in evaluating the effectiveness of potential interventions. The lack of a single grading scale compounds outcome interpretation. Consequently, we assessed the concordance of three of the most commonly used OM grading criteria (World Health Organization (WHO), Radiation Therapy Oncology Group (RTOG), and the common terminology criteria for adverse events (CTCAE). Data was evaluated from two hundred patients with oropharyngeal or oral cavity cancers who underwent chemoradiation therapy and were enrolled in a double-blind, randomized, placebo-controlled trial in which trained assessors evaluated patients twice weekly. WHO, RTOG, and CTCAE scores were assigned centrally by independent evaluators blinded to the study group. Concordance among the three scales for all OM scores and severe OM scores (score ≥ 3) was defined as the percentage agreement and measured using Cohen's weighted Kappa. Of 3,578 OM assessments, 57% had identical scores for all three scales. When any score was considered, the concordance between WHO and RTOG scales was 71% (kappa 0.58; 95%CI: 0.56-0.60), 62% for the WHO and CTCAE scales (kappa 0.46; 95%CI: 0.44-0.48) and 78% for the CTCAE and RTOG scales (kappa 0.69; 95%CI: 0.68-0.71). When patients had severe OM (WHO score ≥ 3), 99.6% (521/523) of the CTCAE OM assessments had scores of 3 or 4 (kappa 0.98; 95%CI: 0.98-0.999) and 97.7% of the RTOG ones (511/523) had scores of 3 or 4 (kappa 0.69; 95%CI: 0.62-0.75). Among patients who had a WHO score of 4, 31.7% (63/199) and 96.0% (196/199) of patients had RTOG or CTCAE scores of 2 or 3, respectively. Discordance was seen with patients who exhibited mild to moderate OM or most severe OM (grade 4) as described by WHO criteria. Whereas scale selection seems less critical in studies in which general "severe mucositis" is the primary outcome, it is particularly important in accurately describing OM's clinical trajectory and the frequency and impact in its most severe forms.

PHOTODYNAMIC THERAPY IN THE TREATMENT OF CHEMOTHERAPY-INDUCED ORAL MUCOSITIS: CLINICAL TRIAL WITH PEDIATRIC PATIENTS

Objective: To evaluate and compare the efficacy of photodynamic therapy and photobiomodulation in the control of chemotherapy-induced oral mucositis in pediatric patients. Study Design: A superiority, randomized, open, controlled, and triple-blind clinical trial consisting of 54 patients aged 10 months to 18 years and totaling 91 cases of oral mucositis were drawn for allocation into 2 groups. Group A (experimental) was subjected to photodynamic therapy (0.01% methylene blue, laser of 660 nm, 100 mW, 0.028 cm2, 3 J) and group B (control) to photobiomodulation (660 nm, 100 mW, 0.028 cm2, 1 J). For evaluating oral mucositis, the World Health Organization and Children's International Mucositis Evaluation Scale (ChIMES) scales were used, and the patients were followed up daily until clinical cure of the lesions. The χ2test, Fisher exact test, Student t test and Mann-Whitney U test, in addition to the mixed linear regression and Poisson models, were used for comparison, with the maximum error admitted of 5%. Results: There was no difference between the groups in regard to the number of sessions necessary for clinical cure of the oral lesions (P = .058), reduction in pain, and difficulty with swallowing or chewing (P> .05). Within each group, however, the reductions were significant (P

Randomized controlled and double‐blinded study of Caphosol versus saline oral rinses in pediatric patients with cancer

Oral mucositis (OM) is a significant side effect of cancer treatment. The purpose of this study was to compare topically administered Caphosol to saline rinses in the prevention of mucositis in pediatric cancer patients. A controlled, double-blinded, and randomized clinical crossover study recruited patients between 2 to 17.99years of age who were diagnosed with a malignancy and were receiving either high-dose methotrexate (≥1g/m2 ), anthracycline, or cisplatin chemotherapy (NCT0280733). All patients received two 7-day cycles of the mouth rinses; that is, one cycle of Caphosol and one cycle of saline in a randomized order. Oral changes and symptoms were evaluated using the World Health Organisation (WHO) toxicity scale and the Children's International Mucositis Evaluation Scale (ChIMES). The primary endpoint was the frequency and severity of OM and oral symptoms. A total of 56 patients were recruited to the study, of whom 45 were randomized with a median age of 6.5years (range 2.1-17.1years). No cases of severe OM were observed. Grade≥3 oral symptoms were present at least once in six (13%) patients during the Caphosol cycle and 13 (29%) patients during the saline cycle (P=.12). The peak of symptom scores was evident at around day 4-7 after administration of the chemotherapy with no marked differences between the rinse solutions. Multivariable regression analysis did not indicate a benefit of using Caphosol over the saline solution. No difference in prevention of oral mucositis was observed between the use of Caphosol or saline rinses.

Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations\u2014a feasibility study and randomized controlled trial

PurposeTo evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC reduces the incidence of severe oral mucositis (OM), oral pain, and opioid use in children undergoing hematopoietic stem cell transplantation (HSCT).MethodsFifty-three children, 4–17 years old, scheduled for HSCT in Sweden were included and randomized to OC or control using a computer-generated list. OC instructions were to cool the mouth with ice for as long as possible during chemotherapy infusions with an intended time of ≥ 30 min. Feasibility criteria in the OC group were as follows: (1) compliance ≥ 70%; (2) considerable discomfort during OC < 20%; (3) no serious adverse events; and (4) ice administered to all children. Grade of OM and oral pain was recorded daily using the WHO-Oral Toxicity Scale (WHO-OTS), Children’s International Oral Mucositis Evaluation Scale, and Numerical Rating Scale. Use of opioids was collected from the medical records.ResultsForty-nine children (mean age 10.5 years) were included in analysis (OC = 26, control = 23). The feasibility criteria were not met. Compliance was poor, especially for the younger children, and only 15 children (58%) used OC as instructed. Severe OM (WHO-OTS ≥ 3) was recorded in 26 children (OC = 15, control = 11). OC did not reduce the incidence of severe OM, oral pain, or opioid use.ConclusionThe feasibility criteria were not met, and the RCT could not show that OC reduces the incidence of severe OM, oral pain, or opioid use in pediatric patients treated with a variety of conditioning regimens for HSCT.Trial registrationClinicalTrials.gov id: NCT01789658

Evaluation of Mucositis in Pediatric Hematopoietic Cell Transplant Patients Receiving Palifermin

Background Oral mucositis (OM) occurs in up to 70-80% of children undergoing myeloablative conditioning during hematopoietic cell transplant (HCT). OM has various negative clinical sequelae; therefore, efforts to prevent this common transplant complication have important potential clinical benefits. The keratinocyte growth factor, palifermin, stimulates the proliferation of mucosal cells and may be protective against the development of OM when administered to patients receiving regimens containing total body irradiation (TBI) or alkylating agents. Methods We performed a retrospective review of children (up to age 21 years) undergoing autologous or allogeneic HCT who received palifermin in the peri-transplant period over a 5-year period (2014-2018) at our institution. Subjects were included if they received TBI (≥12 Gy) or multiple alkylating agents (including melphalan) as part of their conditioning regimen. The recommended dosing is 60 mcg/kg/day intravenously 3 days before conditioning and 3 doses post-HCT on days 0, +1, +2. We excluded children who completed the pre-transplant palifermin doses greater than 48 hours prior to initiation of the conditioning regimen and those who did not receive all 6 planned doses. The primary outcome was the incidence, severity, and duration of mucositis. Secondary outcomes included the need for supportive care measures such as parenteral nutrition (PN) and patient controlled analgesia (PCA) use. We also examined the cost associated with palifermin use. Results A total of 44 children were evaluated. Ten children were excluded due to inappropriate palifermin dosing, two were excluded for infectious complications that resulted in aborting the preparative regimen, and two had incomplete data during chart review. Thirty remaining evaluable subjects were included in the full analysis. The most common chemotherapy-only conditioning regimens were carboplatin/etoposide/melphalan (n=8) and fludarabine/melphalan/thiotepa (n=7); 12 patients received TBI. Twenty-two patients (73.3%) developed Grade 3 or 4 mucositis (Grade 3, n=17; Grade 4, n=5). The median duration of mucositis, PN use, and PCA were 15 days (IQR 10-20), 18 days (IQR 13-25), and 10.5 days (IQR 7-16), respectively. The median hospital length of stay was 33 days (IQR 27-45). When subjects who were excluded due to inappropriate dosing were included in the analysis, there were no significant changes in the primary and secondary outcome measures. The average cost of palifermin per patient is approximately $15,350, translating to $135,080 of additional overall charges annually. Conclusion Despite the use of palifermin, the incidence of severe OM was high in our pediatric population. Given concerns regarding cost and questionable efficacy, the role of palifermin in HCT supportive care remains uncertain.

Taste Alteration Analysis during Hematopoietic Steam Cells Transplantation

Taste changes during hematopoietic steam cells transplantation (HSC) are often acknowledged after the transplantation, however little is known about which flavors and what types of perception changes are experienced by patients during this treatment. The aim of this study was to characterize taste and taste buds atrophy alterations present during the HSC, as well as to verify if there is association among these alterations and clinical variables related to the transplant and oral mucosal toxicity. The impact of taste and oral mucosa alterations on patients' quality of life was also evaluated. We selected 54 patients holding autologous and allogenic HSC, who underwent taste acuity tests prior to conditioning (T0), during neutropenia (T1) and engraftment (T2). It was carried out an acuity test in the perception of sweet, bitter, sour and salty flavors, offered in solutions containing low and high concentrations of watery substances stimulating these flavors. Patients were also submitted to oroscopy for evaluation of oral mucositis and taste buds atrophy. It was found that 69% of patients suffered taste alteration in T1 and 70% in T2. Also flavor intensity was wrongly reported more times by patients in T1 (79%) and T2 (78%) than prior to conditioning. Taste buds atrophy was observed in 74% of patients at T1 and 78% at T2, being correlated to change in the flavor (p = 0.037) at T2. Taste buds atrophy was inversely correlated to TBI treatment in their conditioning, with 42% of patients affected (p = 0.036). Finally, patients suffering mucositis for 7 days or longer presented more taste buds atrophy (p = 0.048).Conclusion: The oral mucositis duration, the conditioning regime and taste buds atrophy are factors that may be associated with greater taste alteration in patients submitted to HSC.