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

• Sponsor: Khon Kaen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03679182
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting; End Stage Cancer	Drug: Olanzapine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Study on Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
• Actual Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine Olanzapine 5 mg at 0, 12, 24 and 36 hours	Drug: Olanzapine; Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours; Other Names: olanzapine 5 mg Tab

Outcome Measures

Primary Outcome Measures

1. Emesis control [48 hours]

   Percentage of patients without emesis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

5. 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.

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

7. Expected life expectancy > 1 month.

8. Patients must be able to read Thai.

9. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jarin Chindaprasirt	Khon Kaen		Thailand	40002

Sponsors and Collaborators

• Khon Kaen University

Investigators

• Study Director: Attakorn Raksasataya, MD, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jarin Chindaprasirt, Assistant professor, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT03679182
• Other Study ID Numbers: HE591547
• First Posted: Sep 20, 2018
• Last Update Posted: Sep 20, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Nausea; Vomiting; Olanzapine

Study Results

No Results Posted as of Sep 20, 2018