drugset / Trial / NCT07287592

Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.

NCT07287592

Phase 3 Not yet recruiting 70 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and those who did not. Participants will: receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for 14 consecutive days from d 1 of induction and 14 days from d1 of continuation . • Subjects will be asked to return for a complete study assessments visit every 14-days during supplementation period for a total of 4 visits Keep a diary of their symptoms of neuropathy and compliance to treatment and any adverse event

Timeline

Start
2025-12-30
Primary completion
2026-12-30
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glutamine Other / unclassified 6 g