Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026
Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients with acute lymphoblastic leukemia: a randomized controlled trial.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo evaluate whether oral cryotherapy (OC) using ice-cold saline reduces the incidence and severity of high-dose methotrexate (HD-MTX)-induced oral mucositis (OM) in children with acute lymphoblastic leukemia (ALL).
methodsThis single-center, open-label, parallel-group randomized controlled trial (RCT) enrolled children aged 3-18 years with ALL undergoing consolidation therapy with HD-MTX. Participants were randomly assigned (1:1) to either OC (ice-cold saline oral rinses) or standard oral care alone. HD-MTX was administered at doses of 3 g/m
resultsA total of 127 patients were randomized. The primary day 14 analysis included 118 participants with available outcome assessments, with 59 participants in each group. The incidence of any-grade OM was significantly lower in the OC group (22.0% vs. 44.1%; P = 0.019). The incidence of OM of WHO grade ≥ II was also significantly lower in the OC group (6.8% vs. 23.7%; P = 0.021), corresponding to a substantial relative risk reduction. After multivariable adjustment, OC remained associated with a lower OM risk (adjusted odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.85; adjusted Cox hazard ratio [HR], 0.42; 95% CI, 0.21-0.84). The results of the reference-based imputation analysis were consistent with those of the primary analysis. However, OM duration did not differ significantly between groups (4.00 vs. 5.00 days; P = 0.318). Subgroup analyses revealed that the protective effect of OC was most pronounced in children older than 6 years (HR 0.25; P for interaction = 0.046) and those receiving MTX at 5 g/m
conclusionsOC using ice-cold saline effectively reduces the day 14 incidence and severity of HD-MTX-induced OM and improves mucositis-free survival in pediatric ALL. These findings were supported by the reference-based imputation analysis. This intervention appears to be safe and feasible; however, confirmation through ITT analyses and multicenter trials using age-stratified randomization is required before its routine clinical implementation.
trial registrationChiCTR2300078327.
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