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Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer

Primary Purpose

Nausea, Neoplasms

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Olanzapine

Haldol

About this trial

This is an interventional treatment trial for Nausea focused on measuring olanzapine, haldol, cancer, nausea, second line treatment, refractory nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >18 years of age Significant nausea/vomiting Failed maxeran and domperidone Underlying treatment of causes has failed Adequate cognitive function Communicates well Exclusion Criteria: Partial/complete bowel obstruction Currently taking Haldol or olanzapine Has drug induced extrapyramidal symptoms Parkinson's disease Undergoing chemotherapy or radiotherapy (RT) to brain, abdomen, stomach or esophagus

Sites / Locations

Tom Baker Cancer Centre

Outcomes

Primary Outcome Measures

Severity of nausea on days 3 and 5

Secondary Outcome Measures

Full Information

NCT ID

NCT00124930

First Posted

July 27, 2005

Last Updated

January 18, 2012

Sponsor

Alberta Health services

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00124930

Brief Title

Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer

Official Title

A Randomized Double-blind, Parallel Group Study Comparing Olanzapine (Zyprexa) With Haloperidol (Novo-peridol) for the Relief of Nausea and Vomiting in Patients With Advanced Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Terminated

Why Stopped

Study suspended due to low enrollment

Study Start Date

May 2005 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alberta Health services

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

Detailed Description

The purpose of this study is to compare the efficacy and safety of haloperidol and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea, Neoplasms

Keywords

olanzapine, haldol, cancer, nausea, second line treatment, refractory nausea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Type

Drug

Intervention Name(s)

Haldol

Primary Outcome Measure Information:

Title

Severity of nausea on days 3 and 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Pereira

Organizational Affiliation

Alberta Cancerboard

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer

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