Nausea in patients with advanced cancer Signs and Symptoms Nausea and vomiting
Conditions
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 pati
Sponsors
University of British Columbia (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of nausea on days 3 and 5 as determined by patient self-report Edmonton Symptom Assessment Scale (ESAS) (Visual Analogue Scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Canada
Outcome results
None listed