Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer|
- DRS-R-98 severity rating score [ Time Frame: Until clearance of the delirium signs or for a maximum of 2 weeks ] [ Designated as safety issue: No ]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.
- Delirium resolution rate [ Time Frame: Until clearance of the delirium signs or for a maximum of 2 weeks ] [ Designated as safety issue: No ]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).
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
Other Name: Zyprexa
|Active Comparator: Haloperidol||
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.
Other Name: Haldol
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539733
|Contact: Henk MW Verheul, MD, PhDfirstname.lastname@example.org|
|VU University Medical Center||Recruiting|
|Amsterdam, Netherlands, 1081HV|
|Contact: Henk MW Verheul, MD, PhD +31-20-4444321 email@example.com|
|Principal Investigator: Henk MW Verheul, MD, PhD|
|Sub-Investigator: Maurice Van der Vorst, MD|
|Sub-Investigator: Liesbeth Neefjes, MD|
|Contact: Aart Beeker, MD +31-23-8907166 firstname.lastname@example.org|
|Principal Investigator: Aart Beeker, MD|
|Principal Investigator:||Henk MW Verheul, MD, PhD||VU University Medical Center|