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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03679182

Enrollment

Registered

2018-09-20

Start date

2018-09-01

Completion date

2021-09-30

Last updated

2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Cancer, Nausea, Vomiting

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.

Interventions

DRUGOlanzapine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Emesis control	48 hours	Percentage of patients without emesis

Countries

Thailand

Contacts

Primary ContactJarin Chindaprasirt, MD

jarich@kku.ac.th+66846831097

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026