Clinical trial NCT01539733: Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer
Official title: Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Advanced Cancer
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2012-02-27
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with advanced cancer
* Age ≥ 18
* Patient or his / her significant other speaks Dutch fluently

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
* Patient has another psychiatric disorder that is considered (by investigator) to interfere with assessment of delirium
* Patient had a QTc-interval of \> 480 msec on ECG made on admission to the medical oncology ward (ECG is not required if patient is admitted to a high-care hospice)
* Patient has a history of neuroleptic malignant syndrome
* Patient has a history of convulsions.

Primary outcomes:
measure: DRS-R-98 severity rating score
timeFrame: Until clearance of the delirium signs or for a maximum of 2 weeks
Secondary outcomes:
measure: Delirium resolution rate
timeFrame: Until clearance of the delirium signs or for a maximum of 2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Hoofddorp
country: Netherlands
facility: Spaarne Hospital
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Henk MW Verheul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.