RecruitingPhase 3NCT06850454
Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy
A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy
Sponsor
Mahidol University
Enrollment
140 participants
Start Date
Jan 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
- age of >18 years old
Exclusion Criteria8
- pregnancy or breast feeding
- has emetic episode within 24 hours
- gut obstruction
- uncontrolled brain metastasis
- allergy to or current use of olanzapine
- concomittant moderate or high emetogenic chemotherapy on day 2-5
- Total bilirubin > 2 mg/dl or creatinine clearance < 30 ml/min
- unable to swallow drug
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Interventions
DRUGolanzapine
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
DRUGPlacebo
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06850454