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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539733
First Posted: February 27, 2012
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
H.M.W. Verheul, VU University Medical Center
  Purpose
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.

Condition Intervention
Delirium Advanced Cancer Drug: Olanzapine Drug: Haloperidol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by H.M.W. Verheul, VU University Medical Center:

Primary Outcome Measures:
  • DRS-R-98 severity rating score [ Time Frame: Until clearance of the delirium signs or for a maximum of 2 weeks ]
    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.


Secondary Outcome Measures:
  • Delirium resolution rate [ Time Frame: Until clearance of the delirium signs or for a maximum of 2 weeks ]
    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).


Enrollment: 101
Study Start Date: March 2010
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olanzapine 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.
Other Name: Zyprexa
Active Comparator: Haloperidol Drug: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539733


Locations
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081HV
Spaarne Hospital
Hoofddorp, Netherlands
Sponsors and Collaborators
VU University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Henk MW Verheul, MD, PhD VU University Medical Center
  More Information

Responsible Party: H.M.W. Verheul, Prof. dr., VU University Medical Center
ClinicalTrials.gov Identifier: NCT01539733     History of Changes
Other Study ID Numbers: 2009/225
2009-013403-55 ( EudraCT Number )
NTR2559 ( Other Identifier: Nederlands Trial Register )
First Submitted: February 21, 2012
First Posted: February 27, 2012
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Neoplasms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Olanzapine
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents