Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated October 8, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2017-04-13; most recent amendment 2025-10-03.
Status change: Not Yet Recruiting → Recruiting 2017-08-28
Trial Details
NCT Number NCT03118986
Lead Sponsor The Hospital for Sick Children
Collaborators: University of California, San Francisco, Children's Mercy Hospital Kansas City, St. Justine's Hospital, Columbia University, Medical University of South Carolina, CancerCare Manitoba, University of North Carolina, Chapel Hill, Nationwide Children's Hospital
Conditions Vomiting in Infants and/or Children, Nausea, Hematopoietic System--Cancer, Oncology
Enrollment 200 participants
Start Date 2017-08-10
Primary Completion 2026-03 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-10-08