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

Phase 3

Not yet recruiting

• Conditions: Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients; Pediatric Cancer
• Interventions: Drug: Olanzapine Tablets; Drug: Placebo

• Registration Number: NCT07035821
• Lead Sponsor: Shanghai Children's Medical Center

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant/fosaprepitant) and 5HT-3 antagonist (ondansetron) and/or dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics.

Exclusion Criteria

• Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine group	Olanzapine Tablets	Oral olanzapine tablets
Control group	Placebo	Oral placebo

Primary Outcome Measures

Name	Time	Method
the CR rate for vomiting in the first 72 hours	in the first 72 hours of the initiation of olanzapine	The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .

Secondary Outcome Measures

Name	Time	Method
the CR rate for nausea in the first 72 hours of the initiation of olanzapine	in the first 72 hours of the initiation of olanzapine	The secondary endpoint was the CR rate for nausea in the first 72 hours of the initiation of olanzapine

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China