Clinical trial · Interventional
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
NCT03679182CI-TRIAL-00034972unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| End Stage Cancer | — | UNRESOLVED | — |
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olanzapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Olanzapine
- description
- Olanzapine 5 mg at 0, 12, 24 and 36 hours
- interventionNames
- Drug: Olanzapine
Primary outcomes (1)
- measure
- Emesis control
- timeFrame
- 48 hours
- description
- Percentage of patients without emesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.