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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013403-55 | EudraCT Number | ||
| NTR2559 | Other Identifier | Nederlands Trial Register |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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The investigators designed a randomised multicenter clinical trial for patients with advanced cancer who are admitted to the medical oncology ward or high-care hospice. On admission all patients with advanced cancer will be asked to participate in this study. Consenting patients will be submitted to delirium observation screening according to the DOS. Subsequently DOS screening will be performed twice weekly until discharge. Each patient who's score is > 3 (DOS positive) is showing significant symptoms of delirium and will be submitted to the revised Delirium Rating Scale (DRS-R-98) to confirm diagnosis. To test validity of the DOS scale for this particular population, each DOS positive score will be randomly matched with a patient with a DOS score < 3 (DOSnegative) and this patient will also be submitted to DRS-R-98. When diagnosis of delirium is confirmed by DRS-98, patients will be randomised between treatment of delirium with olanzapine or haloperidol (usual care). Treatment in both groups will consist of identification and management of underlying aetiologies of delirium if possible and adding neuroleptic medication for symptom control. Patients who recover from their delirium episode as well as their caregivers will be asked to complete the Delirium Experience Questionnaire (DEQ) to assess recall of the delirium experience and the degree of distress related to the delirium episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine | Experimental |
| |
| Haloperidol | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | After randomisation to olanzapine treatment, olanzapine will be started at an initial dose of 2,5 - 5 mg orally or intramuscularly, after 2 hours subsequent titration of dosage will be based on clinical judgement with a maximum of 20 mg per 24 hours divided over a maximum of 3 gifts. Sustenance dose will consist of half of the total titrated dose per 24 hours in one gift. |
| Measure | Description | Time Frame |
|---|---|---|
| DRS-R-98 severity rating score | Primary endpoint for this trial is a DRS-R-98 severity rating score <15,25, as this is a measure for establishing clearance of delirium. | Until clearance of the delirium signs or for a maximum of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium resolution rate | Secondary endpoint is the amount of time elapsed between start of treatment and diminishing of the signs of delirium (DOS <3, DSR-R-98 <15,25). | Until clearance of the delirium signs or for a maximum of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henk MW Verheul, MD, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Amsterdam | 1081HV | Netherlands | |||
| Spaarne Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32162816 | Derived | van der Vorst MJDL, Neefjes ECW, Boddaert MSA, Verdegaal BATT, Beeker A, Teunissen SCC, Beekman ATF, Wilschut JA, Berkhof J, Zuurmond WWA, Verheul HMW. Olanzapine Versus Haloperidol for Treatment of Delirium in Patients with Advanced Cancer: A Phase III Randomized Clinical Trial. Oncologist. 2020 Mar;25(3):e570-e577. doi: 10.1634/theoncologist.2019-0470. Epub 2019 Dec 8. | |
| 30782151 |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Haloperidol | Drug | After randomisation to haloperidol treatment, haloperidol dosing will be titrated, with repeated dosing of 0,5 - 2mg orally or subcutaneously every 40 minutes until signs of delirium diminish, with a maximum of 20 mg orally or 10 mg subcutaneously per 24 hours. Sustenance dose will consist of half of the total titrated dose per 24 hours in one or two gifts. |
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| Hoofddorp |
| Netherlands |
| Derived |
| Neefjes ECW, van der Vorst MJDL, Boddaert MSA, Verdegaal BATT, Beeker A, Teunissen SCC, Beekman ATF, Zuurmond WWA, Berkhof J, Verheul HMW. Accuracy of the Delirium Observational Screening Scale (DOS) as a screening tool for delirium in patients with advanced cancer. BMC Cancer. 2019 Feb 19;19(1):160. doi: 10.1186/s12885-019-5351-8. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |