Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer
Information source: Alberta Cancer Board
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Neoplasms
Intervention: Olanzapine (Drug); Haldol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Alberta Cancer Board Official(s) and/or principal investigator(s):
Jose Pereira, Principal Investigator, Affiliation: Alberta Cancerboard
Overall contact:
Carla Stiles, Phone: 403-210-8423, Email: carla.stiles@calgaryhealthregion.ca
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Severity of nausea on days 3 and 5
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Carla Stiles, Phone: 403-210-8423, Email: carla.stiles@calgaryhealthregion.ca
Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada; Recruiting
Rachel Syme, Ph.D., Phone: 403-521-3388, Email: clinical_trials_tbcc@cancerboard.ab.ca
Additional Information
Starting date: May 2005
Ending date: May 2008
Last updated: July 12, 2006
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