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Olanzapine (ZYPREXA) versus Haloperidol (Novo-Peridol) for the relief of Nausea and Vomiting (N&V) in patients with advanced cancer
ISRCTN ISRCTN58624349
DOI 10.1186/ISRCTN58624349
ClinicalTrials.gov identifier NCT00124930
EudraCT number
Public title Olanzapine (ZYPREXA) versus Haloperidol (Novo-Peridol) for the relief of Nausea and Vomiting (N&V) in patients with advanced cancer
Scientific title A randomised double-blind, parallel-group study comparing Olanzapine (ZYPREXA) with Haloperidol (Novo-Peridol) for the relief of Nausea and Vomiting (N&V) in patients with advanced cancer
Acronym OHN - 1
Serial number at source MCT-71119
Study hypothesis The objective of this study is to compare the efficacy and safety of haloperidol and olanzapine in the control of chronic nausea in patients with advanced cancer who have failed first line anti-emetic therapy with metoclopramide or domperidone.

Please note that as of 28/01/2008 this trial record was updated. All updates to this trial record have been performed under the date 28/01/2008 in the relevant section of the trial record. Please also note that as of 2006 the contact and sponsor of this trial also changed. The previous contact for scientific queries was Dr Jose Pereira, and the previous sponsor was the University of Calgary (Canada).
Lay summary
Ethics approval Health Research Ethics Board, University of Calgary, Calgary, Alberta (Canada) approved on the 31st May 2005 (ref: # 18371)
Study design Multicentre two arm randomised parallel trial using placebo, with study participant, study investigator, and caregiver blinding
Countries of recruitment Canada
Disease/condition/study domain Nausea in patients with advanced cancer
Participants - inclusion criteria Current inclusion criteria as of 28/01/2008:
1. Male or female 18 years or older
2. Significant nausea or vomiting
3. An expressed need for nausea or vomiting to be relieved with medication
4. Patient has failed a prior trial with metoclopramide or domperidone
5. Attempts at addressing probable and possible underlying causes of nausea have been attempted and failed
6. Sufficient cognitive function
7. Ability to communicate well with the study personnel and comply with the requirements of the study
8. Willingness to give written informed consent
9. Able to take oral medications
10. Life expectancy estimated to be greater than 2 weeks

Previous inclusion criteria:
1. Male or female 18 years or older
2. Significant nausea or vomiting
3. An expressed need for nausea or vomiting to be relieved with medication
4. Patient has failed a prior trial with metoclopramide or domperidone
5. Attempts at addressing probable and possible underlying causes of nausea have been attempted and failed
6. Sufficient cognitive function
7. Ability to communicate well with the study personnel and comply with the requirements of the study
8. Willingness to give written informed consent
Participants - exclusion criteria Current exclusion criteria as of 28/01/2008:
1. Has partial or complete bowel obstruction
2. Currently taking haloperidol or olanzapine
3. Has drug-induced extrapyramidal side effects (as identified by the screening and/or baseline examinations and Modified St. Hans Rating Scale)
4. Has a known hypersensitivity to haloperidol or olanzapine
5. Has documented Parkinson's disease
6. Is undergoing chemotherapy or radiation therapy that includes abdomen, brain, oesophagus or stomach in its field
7. Has experienced extrapyramidal syndromes (EPS) or intolerance in the past to olanzapine or haloperidol
8. Concurrently receiving or has received in the last 28 days an investigational drug
9. Has previously participated in this trial

Previous exclusion criteria:
1. Has partial or complete bowel obstruction
2. Currently taking haloperidol or olanzapine
3. Has drug-induced extrapyramidal side effects (as identified by the screening and/or baseline examinations and Modified St. Hans Rating Scale)
4. Has a known hypersensitivity to haloperidol or olanzapine
5. Has documented Parkinsonís disease
6. Is undergoing chemotherapy or radiation therapy that includes abdomen, brain, oesophagus or stomach in its field
Anticipated start date 13/06/2005
Anticipated end date 30/06/2008
Status of trial Stopped
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 80
Interventions 1. Olanzapine (Zyprexa)
2. Haldol (haloperidol)

Added as of 28/01/2008:
Both patients and investigators will be blinded as to which medication the patients will be receiving. Medications will be inserted in opaque capsules to ensure blinding.

Added as of 22/08/2008:
This trial was stopped early due to poor recruitment. The actual end date of this trial was 30/06/2008, and the previous anticipated end date was 31/12/2008.

Contact for public queries:
Carla Stiles
RM 374, HMRB
3330 Hospital Dr. NW
Calgary, AB, T2N 4N1
Canada
Email: carlasti@cancerboard.ab.ca
Tel: +1 403 210 8423
Fax: +1 403 283 8727
Primary outcome measure(s) Severity of nausea on days 3 and 5 as determined by patient self-report Edmonton Symptom Assessment Scale (ESAS) (Visual Analogue Scale).
Secondary outcome measure(s) 1. Treatment satisfaction as assessed by patients (daily)
2. Frequency of adverse events caused by olanzapine and haloperidol as indicated by the Adverse Events Questionnaire
3. Spontaneous report of adverse events by patients and the modified St Hans Rating Scale (daily)
4. Changes in appetite
5. Depression
6. Anxiety as assessed by the ESAS
7. Changes in quality of life parameters as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) (days 3 and 5)
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71119)
Trial website
Publications
Contact name Dr  Gillian Mary  Fyles
  Address BCCA - Centre for the Southern Interior
399 Royal Avenue
  City/town Kelowna, British Columbia
  Zip/Postcode V1Y 5L3
  Country Canada
  Tel +1 250 712 3994
  Fax +1 250 712 3911
  Email gfyles@bccancer.bc.ca
Sponsor University of British Columbia (Canada)
  Address 305-2075 Wesbrook Mall
  City/town Vancouver, British Columbia
  Zip/Postcode V6T 1Z4
  Country Canada
  Sponsor website: http://www.ubc.ca/
Date applied 07/06/2005
Last edited 03/08/2009
Date ISRCTN assigned 23/06/2005
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