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

This study has been terminated.

( Study suspended due to low enrollment )

First Received on July 27, 2005. Last Updated on January 18, 2012 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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
Study Completion Date:	June 2008
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

ClinicalTrials.gov Identifier:	NCT00124930 History of Changes
Other Study ID Numbers:	18731, MCT 71119, ISRCTN58624349
Study First Received:	July 27, 2005
Last Updated:	January 18, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

olanzapine
haldol
cancer

nausea
second line treatment
refractory nausea

Additional relevant MeSH terms:

Neoplasms
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Haloperidol
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012