Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: Olanzapine: Patients in the intervention group will receive oral olanzapine once daily (0.15 mg/kg/dose) 45 min prior to chemotherapy on Day 1 and 24 hours after the first dose on day 2
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Planned for single day highly emetogenic chemotherapy (as defined by Pediatric Oncology Group of Ontario guidelines) 2) Absolute neutrophil count > 1000/mm3, Platelet count > 1 lakhs 3) SGOT/SGPT 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to olanzapine 2) Patients with primary/ metastatic brain tumor 3) Received olanzapine within 3 weeks or another antipsychotic 30 days prior to enrolment 4) CYP1A2 inducers or inhibitors while receiving olanzapine 5) Vomiting within 24 hour prior to treatment 6) Steroids within 24 hour prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of olanzapine as an add on agent to standard therapy (ondansetron and dexamethasone) in control of chemotherapy induced vomiting in pediatric patients aged 3-18 years receiving highly emetogenic chemotherapy Timepoint: 0-72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the safety of olanzapine as an add on agent 2) To determine the need for hospital visits 3) To determine the status of normal oral intake 4) To assess the need for rescue antiemetics Timepoint: 0-72 hours | — |
Countries
India
Contacts
Public ContactDr ABDUL WAJID M
All India Institute Of Medical Sciences, New Delhi
Outcome results
None listed