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Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

NCT03876938 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2019-03-15

No results posted yet for this study

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.

Conditions

  • Antiemetic for Highly Emetogenic Chemotherapy

Interventions

DRUG

aprepitant

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

DRUG

olanzapine 10 mg

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

DRUG

olanzapine 5 mg

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Suthinee Ithimakin, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-08-31
Completion
2020-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876938 on ClinicalTrials.gov