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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:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00124930
First received: July 27, 2005
Last updated: January 18, 2012
Last verified: January 2012
  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:


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

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
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, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on November 23, 2014