Condition category
Signs and Symptoms
Date applied
07/06/2005
Date assigned
23/06/2005
Last edited
03/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gillian Mary Fyles

ORCID ID

Contact details

BCCA - Centre for the Southern Interior
399 Royal Avenue
Kelowna
British Columbia
V1Y 5L3
Canada
+1 250 712 3994
gfyles@bccancer.bc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00124930

Protocol/serial number

MCT-71119

Study information

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

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).

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nausea in patients with advanced cancer

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Olanzapine (ZYPREXA), Haloperidol (Novo-Peridol)

Primary outcome measures

Severity of nausea on days 3 and 5 as determined by patient self-report Edmonton Symptom Assessment Scale (ESAS) (Visual Analogue Scale).

Secondary outcome measures

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)

Overall trial start date

13/06/2005

Overall trial end date

30/06/2008

Reason abandoned

Poor recruitment

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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 Parkinson’s disease
6. Is undergoing chemotherapy or radiation therapy that includes abdomen, brain, oesophagus or stomach in its field

Recruitment start date

13/06/2005

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Canada

Trial participating centre

BCCA - Centre for the Southern Interior
Kelowna, British Columbia
V1Y 5L3
Canada

Sponsor information

Organisation

University of British Columbia (Canada)

Sponsor details

305-2075 Wesbrook Mall
Vancouver
British Columbia
V6T 1Z4
Canada

Sponsor type

University/education

Website

http://www.ubc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71119)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes