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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 suspended.
( Study suspended due to low enrollment )
First Received: July 27, 2005   Last Updated: October 3, 2008   History of Changes
Sponsors and Collaborators: Alberta Cancer Board
CIHR
Information provided by: Alberta Cancer Board
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

MedlinePlus related topics: Cancer Nausea and Vomiting
Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Olanzapine
U.S. FDA Resources
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

Further study details as provided by Alberta Cancer Board:

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 Cancer Board
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 Cancer Board:
olanzapine
haldol
cancer
nausea
second line treatment
refractory nausea

Study placed in the following topic categories:
Neurotransmitter Agents
Vomiting
Tranquilizing Agents
Signs and Symptoms, Digestive
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Haloperidol
Signs and Symptoms
Haloperidol decanoate
Dopamine
Dopamine Agents
Nausea
Peripheral Nervous System Agents

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 May 06, 2009