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

Primary Purpose

Nausea, Vomiting, End Stage Cancer

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jarin ChindaprasirtRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olanzapine

Arm Description

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

Outcomes

Primary Outcome Measures

Emesis control
Percentage of patients without emesis

Secondary Outcome Measures

Full Information

First Posted
September 19, 2018
Last Updated
September 19, 2018
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT03679182
Brief Title
Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
Official Title
A Pilot Study on Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, End Stage Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Olanzapine 5 mg at 0, 12, 24 and 36 hours
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
olanzapine 5 mg Tab
Intervention Description
Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours
Primary Outcome Measure Information:
Title
Emesis control
Description
Percentage of patients without emesis
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years. Diagnosis of advanced malignancy. Failed two standard medications for nausea/vomiting (after 6 hours from last dose). Adequate organ function, including the following: 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. Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula. Expected life expectancy > 1 month. Patients must be able to read Thai. Patients must sign an informed consent document. Exclusion Criteria: Patients with history of abdominal radiotherapy. Patients who receive chemotherapy within 1 week. Patients who take fluoxetine. Patients with heart failure or myocardial infarction in the past 6 months. Patients with QTc prolongation from baseline ECG. Known hypersensitivity to olanzapine. Patients who are unwilling to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jarin Chindaprasirt, MD
Phone
+66846831097
Email
jarich@kku.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Attakorn Raksasataya, MD
Organizational Affiliation
Khon Kaen University
Official's Role
Study Director
Facility Information:
Facility Name
Jarin Chindaprasirt
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaruda Sringam, Master
Phone
6643366592
Email
talnurse8@gmail.com
First Name & Middle Initial & Last Name & Degree
Jarin Chindaprasirt, MD
First Name & Middle Initial & Last Name & Degree
Attakorn Raksasataya, MD
First Name & Middle Initial & Last Name & Degree
Suthan Chanthawong, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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