Efficacy of Melatonin for the Treatment of Moderate to Severe Vincristine-Induced Neuropathy in in Children with Acute Lymphoblastic Leukemia: A Randomized Controlled Trial
Abstract
Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children, accounting for 26% of pediatric blood malignancies. Vincristine is a widely used chemotherapy agent for ALL, but vincristine-induced peripheral neuropathy (VIPN) is the most prevalent and significant side effect associated with its administration. Objectives: This study aims to evaluate the efficacy of melatonin in treating VIPN in children with ALL. Methods: This randomized controlled trial included children aged 5 to 12 years with ALL who were clinically diagnosed with VIPN using the pediatric-modified total neuropathy score. Patients were randomly assigned to either a control or treatment group. The vincristine dose for each of the four treatment phases (induction, consolidation, maintenance, and intensification) was 1.5 mg/m², administered intravenously. Baseline and one-month post-treatment measurements included the CTCAE score (to assess VIPN), PedsQL child and parent scores (to evaluate quality of life), and pediatrics-modified total neuropathy (PEDs MTNs) scores. Patients received either 3 - 5 mg of melatonin or a placebo daily for one month. Results: A total of 20 patients (mean age: 7.45 ± 2.31; 55% female) were included, with 60% allocated to the treatment group. Baseline clinical and demographic data showed no significant differences between groups. The study found that melatonin administration at a dose of 3 mg daily for one month did not significantly improve VIPN in children…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.
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