Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Phase 3

• Conditions: Antiemetic for Highly Emetogenic Chemotherapy
• Interventions: Drug: olanzapine 10 mg; Drug: olanzapine 5 mg; Drug: aprepitant

• Registration Number: NCT03876938
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-01
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
olanzapine 10 mg	olanzapine 10 mg	olanzapine 10 mg/dexamethasone/ ondansetron
olanzapine 5 mg	olanzapine 5 mg	olanzapine 5 mg/dexamethasone/ ondansetron
aprepitant	aprepitant	aprepitant / dexamethasone/ ondansetron

Primary Outcome Measures

Name	Time	Method
no nausea rate	Days 1-5 of chemotherapy	proportion of patients report no nausea

Secondary Outcome Measures

Name	Time	Method
complete remission	Days 1-5 of chemotherapy	no episode of vomiting
>= grade 3 vomiting	Days 1-5 of chemotherapy	higher than grade 3 vomiting

Trial Locations

Locations (2)

Division of medical oncology, department of medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Siriraj Hospital; 🇹🇭 Bangkok, Thailand