- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679182
Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
A Pilot Study on Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a pilot study; open-label prospective clinical trial. Oral olanzapine 5 mg tablet will be given to patients who fail two standard treatment medications for nausea and vomiting within 30 minutes after the first vomiting episode. Other doses of olanzapine will be given at 12, 24, and 36 hours following the first dose concurrently with standard regimen.
Patients with emesis will be followed up after receiving olanzapine every 12 hour for 48 hours. We will record the frequency of vomiting, nausea, and retching.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jarin Chindaprasirt, MD
- Phone Number: +66846831097
- Email: jarich@kku.ac.th
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Recruiting
- Jarin Chindaprasirt
-
Contact:
- Jaruda Sringam, Master
- Phone Number: 6643366592
- Email: talnurse8@gmail.com
-
Principal Investigator:
- Jarin Chindaprasirt, MD
-
Sub-Investigator:
- Attakorn Raksasataya, MD
-
Sub-Investigator:
- Suthan Chanthawong, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-65 years.
- Diagnosis of advanced malignancy.
- Failed two standard medications for nausea/vomiting (after 6 hours from last dose).
Adequate organ function, including the following:
- Hepatic: bilirubin ≤1.5 times the upper limit of normal (x ULN); aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement), alkaline phosphatase (AP) ≤5.0 x ULN.
- Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.
- Expected life expectancy > 1 month.
- Patients must be able to read Thai.
- Patients must sign an informed consent document.
Exclusion Criteria:
- Patients with history of abdominal radiotherapy.
- Patients who receive chemotherapy within 1 week.
- Patients who take fluoxetine.
- Patients with heart failure or myocardial infarction in the past 6 months.
- Patients with QTc prolongation from baseline ECG.
- Known hypersensitivity to olanzapine.
- Patients who are unwilling to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olanzapine
Olanzapine 5 mg at 0, 12, 24 and 36 hours
|
Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emesis control
Time Frame: 48 hours
|
Percentage of patients without emesis
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Attakorn Raksasataya, MD, Khon Kaen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- 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
- Olanzapine
Other Study ID Numbers
- HE591547
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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