efficacy of melatonin for the treatment of moderate to severe vincristine-induced neuropathy in in children with acute lymphoblastic leukemia: a randomized controlled trial

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 with all. however, a significant difference was observed in pain scores after the intervention, with children in the placebo group reporting a significantly higher mean pain score compared to the treatment group (4 ± 2.39 vs. 2 ± 2.26, p = 0.041). melatonin had a substantial and statistically significant impact on the quality of life of the children and their parents, as well as on the children’s pain scores. conclusions: although the ctcae score was reduced, no significant difference was observed between the melatonin and placebo groups. however, melatonin demonstrated a positive effect on health-related quality of life and pain reduction in children with all diagnosed with vipn.