A clinical trial to study the effect of olanzapine in patients receiving highly emetogenic chemotherapy
Phase 3
Completed
- Conditions
- Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
- Registration Number
- CTRI/2019/01/017317
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 128
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 < 3 times upper limit of normal and serum bilirubin < 1.5 times upper limit of normal
4) Written informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method