Oral Cryotherapy for Prevention of Oral Mucositis Following High-Dose Methotrexate in Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Study

Oral cryotherapy is a simple, low-cost intervention that may reduce high-dose methotrexate (HD-MTX)-induced oral mucositis in children with acute lymphoblastic leukemia. In this open-label, randomized, crossover study conducted at a tertiary care hospital in northern India, 40 HD-MTX courses in 10 children aged 2 to 18 years were evaluated. Participants received oral cryotherapy during methotrexate infusion in 1 cycle and routine oral care alone in the alternate cycle. Oral mucositis occurred in 40% of cryotherapy courses and 45% of control courses. Although the difference in incidence was not significant, cryotherapy significantly reduced mucositis severity: 87.5% of participants in the cryotherapy group had mild mucositis, compared with 77.8% in the control group. Among children who developed mucositis, pain-function scores were lower with cryotherapy, and mucositis duration was shorter. Analgesic use and hospitalization were also reduced. Oral cryotherapy was feasible and well tolerated, with participants maintaining cryotherapy for a mean duration of more than 40 minutes per session.