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

Khon Kaen University

Status and phase: Unknown; Phase 2

Conditions: Vomiting; Nausea; End Stage Cancer

Treatments: Drug: Olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT03679182

HE591547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Olanzapine

Experimental group

Description:

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

Treatment:

Drug: Olanzapine