Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Study Overview
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Brief Summary
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Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.

Detailed Description
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Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.

Official Title
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Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy

Conditions
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Antiemetic for Highly Emetogenic Chemotherapy

Intervention / Treatment
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* Drug: aprepitant
* Drug: olanzapine 10 mg
* Drug: olanzapine 5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically proved of solid malignancy receive first cycle of cisplatin >= 50 mg/m2 or cyclophosphamide/doxorubicin Exclusion Criteria: pregnancy patients with episode of vomiting within 24 hours before starting chemotherapy uncontrolled brain/ CNS metastasis gut obstruction receive combination of moderate or high emetogenic chemotherapy during Day 2-5 Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone currently receive olanzapine with other indication and plan to continue the drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aprepitant<br>aprepitant / dexamethasone/ ondansetron | Drug: aprepitant<br>* aprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4<br>|
| Experimental: olanzapine 10 mg<br>olanzapine 10 mg/dexamethasone/ ondansetron | Drug: olanzapine 10 mg<br>* olanzapine 10 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 10 mg orally D2-4, dexamethasone 8 mg/day orally D2-4<br>|
| Experimental: olanzapine 5 mg<br>olanzapine 5 mg/dexamethasone/ ondansetron | Drug: olanzapine 5 mg<br>* olanzapine 5 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 5 mg orally D2-4, dexamethasone 8 mg/day orally D2-4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no nausea rate | proportion of patients report no nausea | Days 1-5 of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | no episode of vomiting | Days 1-5 of chemotherapy | 
| >= grade 3 vomiting | higher than grade 3 vomiting | Days 1-5 of chemotherapy |