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Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy
Sponsor: Shanghai Children's Medical Center
Summary
Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
Official title: Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial
Key Details
Gender
All
Age Range
5 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-07-01
Completion Date
2026-07-30
Last Updated
2025-06-25
Healthy Volunteers
No
Interventions
Olanzapine Tablets
Oral olanzapine tablets
Placebo
Oral placebo
Locations (1)
Shanghai Children's Medical Center
Shanghai, China