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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124930
First Posted: July 29, 2005
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
AHS Cancer Control Alberta
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


Further study details as provided by AHS Cancer Control Alberta:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00124930     History of Changes
Other Study ID Numbers: 18731
MCT 71119
ISRCTN58624349
First Submitted: July 27, 2005
First Posted: July 29, 2005
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by AHS Cancer Control Alberta:
olanzapine
haldol
cancer
nausea
second line treatment
refractory nausea

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Olanzapine
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents