Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

March 14, 2019 updated by: Mahidol University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
          • Suthinee Ithimakin, MD
      • Bangkok, Thailand, 10700
        • Recruiting
        • Division of medical oncology, department of medicine Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • Suthinee Ithimakin, MD
        • Sub-Investigator:
          • Pathra Theeratrakul, MD
        • Sub-Investigator:
          • Apirom Laocharoenkiat
        • Sub-Investigator:
          • Charuwan Akewanlop, MD
        • Sub-Investigator:
          • Akarin Nimmannit, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aprepitant
aprepitant / dexamethasone/ ondansetron
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
Experimental: olanzapine 10 mg
olanzapine 10 mg/dexamethasone/ ondansetron
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
Experimental: olanzapine 5 mg
olanzapine 5 mg/dexamethasone/ ondansetron
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Suthinee Ithimakin, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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