Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care

Study Overview
=================
Brief Summary
-----------------
Oral olanzapine showed superior antiemetic efficacy to metoclopramide as rescue treatment to control breakthrough emesis induced by chemotherapy. This study aims to evaluate safety and efficacy of olanzapine for nausea and vomiting in advanced cancer patients.

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.

Official Title
-----------------
A Pilot Study on Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care

Conditions
-----------------
Nausea, Vomiting, End Stage Cancer

Intervention / Treatment
-----------------
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine<br>Olanzapine 5 mg at 0, 12, 24 and 36 hours | Drug: Olanzapine<br>* Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours<br>* Other names: olanzapine 5 mg Tab;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emesis control | Percentage of patients without emesis | 48 hours |