NCT07035821Not yet recruitingPhase 3
Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy
Olanzapine for the Treatment of Breakthrough Chemotherapy-Induced Vomiting in Children: An Open-label, Randomized Phase 3 Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Shanghai Children's Medical Center
- Diseases
- Childhood cancers
- NCT number
- NCT07035821
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 1 Jul 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.
Who the study is looking for
- \- The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant/fosaprepitant) and 5HT-3 antagonist (ondansetron) and/or dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics.
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Children's Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.