NCT07035821

Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy

Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy were randomly assigned to the control(placebo) or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or placebo for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.

Conditions

• Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients
• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	Olanzapine Tablets	Oral olanzapine tablets
DRUG	Placebo	Oral placebo

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: China