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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:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00124930
First received: July 27, 2005
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  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
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:

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 May 23, 2013