Oral Cryotherapy for the Prevention of Oral Mucositis in Children With Hematolymphoid Malignancies Receiving IV Methotrexate-Based Chemotherapy: A Randomized Controlled Trial.
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BACKGROUND AND AIMS: Oral mucositis (OM) is a debilitating adverse effect of many chemotherapeutic drugs. Oral cryotherapy using ice cubes/chips is used to prevent oral mucositis in adults post 5-fluorouracil (5-FU)/melphalan administration. However, its efficacy in the prevention of OM post-methotrexate-based chemotherapy has not been investigated. The current trial aimed to evaluate the effectiveness of oral cryotherapy in the prevention of oral mucositis in children with hematolymphoid malignancies receiving intravenous (IV) methotrexate-based chemotherapy. METHODS: Children aged 5-18 years scheduled to receive a course of IV methotrexate-based chemotherapy were randomized to either intervention or control arm. Children in the intervention arm were asked to suck on ice cubes/lollies for the entire duration of a 1-h infusion for Capizzi methotrexate or suck during the initial bolus infusion and then every 6-8 h till the beginning of leucovorin rescue if receiving high-dose methotrexate. RESULTS: Between February 2022 and January 2024, 86 courses of IV methotrexate were randomized, with 45 courses in the intervention arm and 41 courses in the control arm. Ten patients (22.2%) in the intervention arm and 26 (63.4%) in the control arm developed oral mucositis. The difference in the incidence of oral mucositis was statistically significant, with the intervention arm having a lower incidence of oral mucositis (RR 0.35, 95% confidence interval: 0.19-0.63, p ≤ 0.001). CONCLUSIONS: A significant reduction was observed in the incidence of OM with oral cryotherapy among children with hematolymphoid malignancies receiving IV methotrexate.