Health Condition 1: R112- Nausea with vomiting, unspecified
Conditions
Interventions
Intervention1: Olanzapine 5mg: After chemotherapy, both groups (Olanzapine and control) will receive an intravenous injection of dexamethasone 12mg and ondansetron 8mg once on day 1.
From day 2 to da
Sponsors
G.Karthik
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 to 75 years of either gender Patients receiving Platinum based chemotherapy regimen for cancer treatment Eastern Co-operative Oncology Group (ECOG) performance status - 0/1 No prior/ current use of anti-psychotic medications No history of hypersensitivity to olanzapine or study drugs
Exclusion criteria
Exclusion criteria: Patients experiencing clinically significant nausea in 24 hours preceding the first dose Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of olanzapine and ondansetron in prevention and control of Platinum based chemotherapy induced nausea and vomitingTimepoint: Nausea and vomiting is assessed by Multinational Association of Supportive Care in Cancer Tool (MASCC) and Visual Analogue Scale (VAS) score at baseline, chemotherapy cycle 1,2,3,4,5,6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the adverse effects of olanzapine & ondansetron using WHO causality assessment scale & Naranjo scale.Timepoint: Adverse effects of drug & safety will be assessed by WHO causality assessment scale & Naranjo scale at baseline, chemotherapy cycle 1,2,3,4,5,6 | — |
Countries
India
Contacts
Public ContactBhuvana K
Sri Devaraj Urs Medical College
Outcome results
None listed