Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539733
• Other study ID #: 2009/225
• Secondary ID: 2009-013403-55NT
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: April 6, 2017
• Start date: March 2010
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Delirium
• Neoplasms

Intervention

Drug:
• Olanzapine
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.
• 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.

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Spaarne Hospital	Hoofddorp

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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