- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876938
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
Status
Unknown
Intervention / Treatment
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
- Name: Suthinee Ithimakin, MD
- Phone Number: +6624194489
- Email: aesi105@yahoo.co.th
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:
- Suthinee Ithimakin, MD
- Phone Number: 662-419-4489
- Email: aesi105@yahoo.co.th
-
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.
Sponsor
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Neurokinin-1 Receptor Antagonists
- Olanzapine
- Aprepitant
Other Study ID Numbers
- 728/2561(EC4)
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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