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

This study has been suspended.

( Study suspended due to low enrollment )

First Received: July 27, 2005 Last Updated: October 3, 2008 History of Changes

Sponsor:	Alberta Health Services
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00124930

Purpose

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.

Condition	Intervention	Phase
Nausea Neoplasms	Drug: Olanzapine Drug: Haldol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Olanzapine

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:

Severity of nausea on days 3 and 5

Estimated Enrollment:	80
Study Start Date:	May 2005
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124930

Locations

Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2

Sponsors and Collaborators

Alberta Health Services

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Jose Pereira

Alberta Cancerboard

More Information

No publications provided

Study ID Numbers:	18731, MCT 71119, ISRCTN58624349
Study First Received:	July 27, 2005
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00124930 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

olanzapine
haldol
cancer

nausea
second line treatment
refractory nausea

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Haloperidol
Signs and Symptoms
Therapeutic Uses
Nausea

Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Neoplasms
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2010