Delirium in patients with advanced cancer
Conditions
Interventions
Trade Name: Haldol
Pharmaceutical Form: Oral drops, suspension
INN or Proposed INN: Haloperidol
CAS Number: 52-86-8
Other descriptive name: HALOPERIDOL
Concentration unit: mg milligram(s)
Concentratio
Sponsors
VU university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient has been diagnosed with advanced cancer; • Age = 18; • Patient or his / her significant other speaks Dutch fluently. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Delirium is due to alcohol withdrawal; • Patient has been diagnosed with glaucoma, Parkinson’s disease or dementia; • Patient is being treated with other neuroleptic medication or lithium (except for low dose neuroleptics used in the treatment of neuropathic pain; • Patient has another psychiatric disorder that is considered (by investigator) to interfere withassessment of delirium; • Patient had a QTc-interval of > 480 msec on ECG made on admission; • Patient has a history of neuroleptic malignant syndrome; • Patient has a history of convulsions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To validate the DOS scale for palliative care patients with advanced cancer. 2. To compare the efficacy of olanzapine treatment with haloperidol treatment (standard care) in a randomised clinical trial with regard to reversibility and time to recovery. ;Secondary Objective: 1. To determine delirium recall and delirium-related distress in patients with advanced cancer and their primary caregivers. ;Primary end point(s): Primary endpoints for validation of the DOS scale (primary aim 1) are the sensitivity and specificity of the DOS score compared with the DRS-R-98 as the gold standard. Repeated DOS and DRS-R-98 measurements will be used to determine the test re-test reliability of the DOS. Primary endpoint for comparison of the efficacy of haloperidol and olanzapine treatment (primary aim 2) is the percentage of patients that has a DRS-R-98 severity rating score 4.5 points before or on day 7, as this is a measure for establishing recovery from delirium. Secondary endpoint for primary aim 2 is the time interval between start of treatment and diminishing of the signs of delirium (DOS 4.5 points on the total scale). ;Timepoint(s) of evaluation of this end point: T0, T1, T2, T3, T6, T7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable ;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Netherlands
Contacts
Public ContactProf. dr. Henk M.W. Verheul
VU university medical center
Outcome results
None listed