Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Olanzapine: Oral olanzapine once a day at dose 0.14mg/kg rounded to nearest multiple of 2.5mg upto maximum of 10mg. To be given on days of chemotherapy and for 3 more days post chemothe
Sponsors
Dr Nikita Jakhar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of malignancy 2. Scheduled for highly emetogenic chemotherapy 3. Should be able to swallow the drug 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Have had treatment within 14 days prior to study enrolment with olanzapine or 30 days prior with another antipsychotic agent 2.Planned to receive quinolone antibiotics or other antipsychotic agents, citalopram, amifostine, CYP1A2 inducers or inhibitors 3. History of seizure disorder 4. History of hypersensitivity to olanzapine 5. Vomited in the prior 24 hours to first dose of chemotherapy 6.Abnormal lab values (absolute neutrophil count less than 1000/mm3, total leucocyte count less than 3000/mm3, platelet count less than 100,000mm3, AST/ALT more than 2.5 times of upper limit of normal, total serum bilirubin more than 1.5 times of upper limit of normal and serum creatinine more than 1.5 times of upper limit of normal) 7. Steroids within 24 hours prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of olanzapine versus aprepitant when combined with ondansetron and dexamethasone in control of chemotherapy induced vomiting for the acute periodTimepoint: Upto 24 hours after completion of the chemotherapy block | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare between the study and control groups the efficacy of control in chemotherapy induced vomiting for delayed and overall periodTimepoint: Upto 120 hours after completion of the chemotherapy block;2.To compare between the study and control groups the no nausea rates for acute, delayed and overall periodTimepoint: Upto 120 hours after completion of the chemotherapy block;3.To compare between the study and control groups the need for rescue antiemetic medicationsTimepoint: Upto 120 hours after completion of the chemotherapy block;4. To compare between the study and control groups the need for hospital visitsTimepoint: Upto 120 hours after completion of the chemotherapy block;5.To compare between the study and control groups the incidence of adverse eventsTimepoint: Upto the scheduled next cycle of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Jagdish Prasad Meena
AIIMS Delhi
Outcome results
None listed