NCT03118986

RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 30 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy

Conditions

• Vomiting in Infants and/or Children
• Nausea
• Hematopoietic System--Cancer
• Oncology

Interventions

Type	Name	Description
DRUG	Olanzapine	olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
DRUG	Placebo Oral Tablet	Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine

Timeline

• Start date: 2017-08-10
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2017-04-18
• Last updated: 2025-10-08

Locations

10 sites across 3 countries: United States, Canada, India

Regulatory

• FDA-regulated drug study