Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients…

Randomized trialSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer· Aug 2026

Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients with acute lymphoblastic leukemia: a randomized controlled trial.

Luyang Zhang, Chunyan Wang, Sandip Patil … Yan Yin

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Pediatric Hematology & OncologyRandomized trialQ1IF 3.3

Oral cryotherapy nearly halved oral mucositis incidence in children on high-dose methotrexate

Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients with acute lymphoblastic leukemia: a randomized controlled trial.

Luyang Zhang … Yan Yin

Supportive care in cancer · Aug 2026

Purpose

To evaluate whether oral cryotherapy (oral cryotherapy) using ice-cold saline reduces the incidence and severity of high-dose methotrexate (high-dose methotrexate)-induced oral mucositis (oral mucositis) in children with acute lymphoblastic leukemia (acute lymphoblastic leukemia).

Methods

Were randomly assigned (1:1) to either oral cryotherapy (ice-cold saline oral rinses) or standard oral care alone.

n = 127 patients

Results

oral mucositis was less than half as common with cryotherapy

adjusted OR 0.37 (95% CI 0.16 to 0.85)

null 1

0.16

0.85

CI excludes the null - significant

More results

The primary day 14 analysis included 118 participants with available outcome assessments, with 59 participants in each group.

More results

After multivariable adjustment, oral cryotherapy remained associated with a lower oral mucositis 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.

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Conclusion · 1 of 3

Oral cryotherapy using ice-cold saline effectively reduces the day 14 incidence and severity of high-dose methotrexate-induced oral mucositis and improves mucositis-free survival in pediatric acute lymphoblastic leukemia.

Conclusion · 2 of 3

These findings were supported by the reference-based imputation analysis.

Conclusion · 3 of 3

This intervention appears to be safe and feasible; however, confirmation through intention-to-treat analyses and multicenter trials using age-stratified randomization is required before its routine clinical implementation.

Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients with acute lymphoblastic leukemia: a randomized controlled trial.

Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients with acute lymphoblastic leukemia: a randomized controlled trial.

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