Olanzapine (ZYPREXA) versus Haloperidol (Novo-Peridol) for the relief of Nausea and Vomiting (N&V) in patients with advanced cancer
| ISRCTN | ISRCTN58624349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58624349 |
| ClinicalTrials.gov number | NCT00124930 |
| Secondary identifying numbers | MCT-71119 |
- Submission date
- 07/06/2005
- Registration date
- 23/06/2005
- Last edited
- 01/02/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Gillian Mary Fyles
Scientific
Scientific
BCCA - Centre for the Southern Interior
399 Royal Avenue
Kelowna, British Columbia
V1Y 5L3
Canada
| Phone | +1 250 712 3994 |
|---|---|
| gfyles@bccancer.bc.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | Health Research Ethics Board, University of Calgary, Calgary, Alberta (Canada) approved on the 31st May 2005 (ref: # 18371) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Olanzapine (ZYPREXA), Haloperidol (Novo-Peridol) |
| Primary outcome measure | 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 study start date | 13/06/2005 |
| Overall study end date | 30/06/2008 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| 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 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 Parkinsons 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
Study participating centre
BCCA - Centre for the Southern Interior
Kelowna, British Columbia
V1Y 5L3
Canada
V1Y 5L3
Canada
Sponsor information
University of British Columbia (Canada)
University/education
University/education
305-2075 Wesbrook Mall
Vancouver, British Columbia
V6T 1Z4
Canada
| Website | http://www.ubc.ca/ |
|---|---|
"ROR" |
https://ror.org/03rmrcq20 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71119)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/02/2019: Clinicaltrials.gov states that this trial was terminated by January 2012 due to low accrual
