Low Dose Olanzapine to the Prophylaxis of Nausea and Vomiting Induced by Chemotherapy in Children and Adolescents
Summary
Chemotherapy-induced nausea and vomiting continues to be a significant problem in children and adolescents. Standard antiemetic therapy, including a 5-HT3 antagonist, aprepitant, and a corticosteroid, achieves complete control in less than 50% of patients. Studies have shown that the addition of large doses of olanzapine improves control, including in children and adolescents. However, olanzapine has not yet been included in standard recommendations in the pediatric population. Studies in adults indicate that the dose of the drug can be halved without loss of effectiveness and with a decrease in toxicity. This open-label, randomized, phase III trial evaluates the efficacy and safety of adding low-dose olanzapine to standard prevention of nausea and vomiting induced by highly emetogenic chemotherapy in children and adolescents.
Timeline
- Start
- 2022-04-01
- Primary completion
- 2024-03
- Completion
- 2024-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 2.5 mg | Oral |
| Subject | Olanzapine | Small molecule | 5 mg | Oral |
| Background | Aprepitant | Other / unclassified | 80 mg | Oral |
| Background | Aprepitant | Other / unclassified | 125 mg | Oral |
| Background | Dexamethasone | Small molecule | 5 mg/m2 | Intravenous |
| Background | Ondansetron | Other / unclassified | 0.15 mg/kg | Intravenous |