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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03679182
• Other study ID #: HE591547
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2018
• Est. completion date: September 2021

Study information

• Verified date: September 2018
• Source: Khon Kaen University
• Contact: Jarin Chindaprasirt, MD
• Phone: +66846831097
• Email: jarich[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Cancer
• Nausea
• Vomiting

Intervention

Drug:
• Olanzapine
Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours

Locations

Country	Name	City	State
Thailand	Jarin Chindaprasirt	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emesis control	Percentage of patients without emesis	48 hours