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A study to compare efficacy of olanzapine versus aprepitant for preventing chemotherapy induced nausea and vomiting in children with cancer

Phase 3
Conditions
Health Condition 1: C00-D49- Neoplasms
Registration Number
CTRI/2024/08/072292
Lead Sponsor
Dr Nikita Jakhar
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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