Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy

Launched by SHANGHAI CHILDREN'S MEDICAL CENTER · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medicine called olanzapine works to stop vomiting in children and teenagers who are receiving strong chemotherapy treatments for cancer. Sometimes, even when children take medicines to prevent nausea and vomiting during chemotherapy, they still throw up. This study will compare olanzapine to another medicine called metoclopramide to see which one is safer and more effective in stopping this breakthrough vomiting.

Children and teens between the ages of 5 and 18 who have cancer and are already taking standard anti-nausea medicines but still experience vomiting might be eligible to join. Participants need to be in generally good health aside from their cancer and should not have certain conditions like severe kidney or heart problems, allergies to the study medicines, or brain-related illnesses. If they join, they can expect to receive either olanzapine or metoclopramide and be closely monitored to see how well the medicine controls their vomiting and if there are any side effects. This trial has not started recruiting yet, but it aims to find better ways to help young patients feel more comfortable during their cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 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.
• Exclusion Criteria:
• • 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.