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Prevention of oral mucositis in pediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash

ABSTRACT: Interventions: Two period cross-over trial. Intervention with mouth-rinsing will commence at the start of either induction, consolidation, or re-induction chemotherapy phase. Group 1 will be rinse with 10 mL of 0.12% chlorhexidine gluconate mouthwash twice daily, and Group 2 will rinse with 15 mL of 1% povidone iodine mouthwash twice daily, for 14 days during the first period of study. Alkaline saline mouthrinse will be used by the subjects during the 2 week ‘washout’ time between the two periods of study. The two groups will then switch mouthrinses during the second study period. The occurrence of ulcerative lesions and severity of mucositis will be measured at baseline and twice weekly of each study period, using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale. If oral mucositis/ulceration develops during either period and persists beyond 14 days, the subjects will continue to use the mouthwash assigned to their group until lesions heal. A participant diary on the use of mouthwash and other oral care hygiene measures such as toothbrushing and flossing will be used to monitor adherence to treatment. Primary outcome(s): determining whether there is a difference in effect of 0.12% chlorhexidine and 1% povidone iodine mouthrinses that are both accepted as standard of care for oral mucositis in pediatric cancer patients using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale[2 weeks] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Efficacy

DISEASE(S): Leukemia,Oral And Gastrointestinal-inflammatory Bowel Disease,Oral Mucositis,Cancer-children's-leukaemia & Lymphoma

PROVIDER: 2460527 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background Toxicity of the oral and gastrointestinal mucosa induced by high-dose melphalan is a clinical challenge with no documented prophylactic interventions or predictive tests. The aim of this study was to describe molecular changes in human oral mucosa and to identify biomarkers correlated with the grade of clinical mucositis. Methods and Findings Ten patients with multiple myeloma (MM) were included. For each patient, we acquired three buccal biopsies, one before, one at 2 days, and one at 20 days after high-dose melphalan administration. We also acquired buccal biopsies from 10 healthy individuals that served as controls. We analyzed the biopsies for global gene expression and performed an immunohistochemical analysis to determine HLA-DRB5 expression. We evaluated associations between clinical mucositis and gene expression profiles. Compared to gene expression levels before and 20 days after therapy, at two days after melphalan treatment, we found gene regulation in the p53 and TNF pathways (MDM2, INPPD5, TIGAR), which favored anti-apoptotic defense, and upregulation of immunoregulatory genes (TREM2, LAMP3) in mucosal dendritic cells. This upregulation was independent of clinical mucositis. HLA-DRB1 and HLA-DRB5 (surface receptors on dendritic cells) were expressed at low levels in all patients with MM, in the subgroup of patients with ulcerative mucositis (UM), and in controls; in contrast, the subgroup with low-grade mucositis (NM) displayed 5–6 fold increases in HLA-DRB1 and HLA-DRB5 expression in the first two biopsies, independent of melphalan treatment. Moreover, different splice variants of HLA-DRB1 were expressed in the UM and NM subgroups. Conclusions Our results revealed that, among patients with MM, immunoregulatory genes and genes involved in defense against apoptosis were affected immediately after melphalan administration, independent of the presence of clinical mucositis. Furthermore, our results suggested that the expression levels of HLA-DRB1 and HLA-DRB5 may serve as potential predictive biomarkers for mucositis severity

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Prevention of oral mucositis in pediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash

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