drugset / Trial / NCT03118986
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
Phase 2
Recruiting
200 enrolled
The Hospital for Sick Children
CancerCare Manitoba · collabChildren's Mercy Hospital Kansas City · collabColumbia University · collabMedical University of South Carolina · collabNationwide Children's Hospital · collabSt. Justine's Hospital · collabUniversity of California, San Francisco · collabUniversity of North Carolina, Chapel Hill · collab
RandomizedParallel-groupTriple-blindSupportive care
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
Timeline
- Start
- 2017-08-10
- Primary completion
- 2026-03
- Completion
- 2026-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Olanzapine | Small molecule | 0.1 mg/kg | Oral |