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

Phase 2

• Conditions: Nausea; End Stage Cancer; Vomiting
• Interventions: Drug: Olanzapine

• Registration Number: NCT03679182
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-01
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-19
• Last Update Submitted: 2018-09-19
• Study First Posted: 2018-09-20
• Last Update Posted: 2018-09-20
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age 18-65 years.

2. Diagnosis of advanced malignancy.

3. Failed two standard medications for nausea/vomiting (after 6 hours from last dose).

4. Adequate organ function, including the following:

   1. 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.
   2. Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.

5. Expected life expectancy > 1 month.

6. Patients must be able to read Thai.

7. Patients must sign an informed consent document.

Exclusion Criteria

1. Patients with history of abdominal radiotherapy.
2. Patients who receive chemotherapy within 1 week.
3. Patients who take fluoxetine.
4. Patients with heart failure or myocardial infarction in the past 6 months.
5. Patients with QTc prolongation from baseline ECG.
6. Known hypersensitivity to olanzapine.
7. Patients who are unwilling to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	Olanzapine 5 mg at 0, 12, 24 and 36 hours

Primary Outcome Measures

Name	Time	Method
Emesis control	48 hours	Percentage of patients without emesis

Trial Locations

Locations (1)

Jarin Chindaprasirt; 🇹🇭 Khon Kaen, Thailand