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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by VU University Medical Center
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
H.M.W. Verheul, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01539733
First received: February 21, 2012
Last updated: February 21, 2014
Last verified: February 2014
  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
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

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 300
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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539733

Contacts
Contact: Henk MW Verheul, MD, PhD +31-20-4444321 h.verheul@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081HV
Contact: Henk MW Verheul, MD, PhD    +31-20-4444321    h.verheul@vumc.nl   
Principal Investigator: Henk MW Verheul, MD, PhD         
Sub-Investigator: Maurice Van der Vorst, MD         
Sub-Investigator: Liesbeth Neefjes, MD         
Spaarne Hospital Recruiting
Hoofddorp, Netherlands
Contact: Aart Beeker, MD    +31-23-8907166    abeeker@spaarneziekenhuis.nl   
Principal Investigator: Aart Beeker, MD         
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

No publications provided

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, NTR2559
Study First Received: February 21, 2012
Last Updated: February 21, 2014
Health Authority: Netherlands: Central Committee on Research involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on September 30, 2014