Study of Olanzapine Added to Standard Treatment to Prevent Vomiting in Children Receiving Strong Chemotherapy

What this Trial Is About

Children receiving highly emetogenic chemotherapy, including those undergoing hematopoietic stem cell transplant conditioning, often experience chemotherapy-induced nausea and vomiting CINV despite standard antiemetic treatments. Researchers are evaluating whether adding olanzapine to standard antiemetics can better control vomiting caused by chemotherapy in children. Olanzapine is already used safely in children with psychiatric conditions, does not interfere with chemotherapy, and is affordable. Participants will be randomly assigned to receive either olanzapine along with standard antiemetics or a placebo plus standard antiemetics. Olanzapine will be given orally once daily at 0.1 mgkg per dose, with a maximum of 10 mg per dose, based on the childs body weight. The study requires inpatient admission from the first dose until 24 hours after the last dose. The trial uses a triple-blind design to compare these treatments during the acute phase of chemotherapy. During the study, children will be monitored for vomiting control up to 8 days and for nausea and vomiting control up to 1 month. Safety evaluations include monitoring weight, various laboratory tests, and adverse events. The impact of olanzapine on transplant outcomes such as veno-occlusive disease and graft-versus-host disease will be assessed up to 100 days post-transplant. Participation includes scheduled antiemetic prophylaxis and assessments using validated nausea tools. The trial is expected to continue through April 2026.

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