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Active Not Recruiting
NCT01949662
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
Conditions: Advanced Cancers
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 93
Sponsor: M.D. Anderson Cancer Center
Location: University of Texas MD Anderson Cancer Center Houston Texas
Summary
This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.
Eligibility Criteria
Inclusion Criteria:
* PATIENTS:
* Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)
* Admitted to Acute Palliative Care Unit (APCU)
* Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV- TR) criteria
* Hyperactive/mixed delirium with RASS \>= 2 in the last 24 hours
* On scheduled haloperidol of =\< 8 mg in the last 24 hours
* Legally authorized representative consent
* FAMILY CAREGIVERS:
* Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
* Age 18 or older
* At the patient's bedside at least 4 hours each day during patient delirium episode
* Patients and family caregivers able to communicate in English or Spanish
Exclusion Criteria:
* PATIENTS
* History of myasthenia gravis or acute narrow angle glaucoma
* History of neuroleptic malignant syndrome
* History of Parkinson's disease or dementia
* Uncontrolled seizure disorder
* History of hypersensitivity to haloperidol or benzodiazepine
* On regular doses of benzodiazepine or chlorpromazine within the past 48 hours
* Previously documented and persistent corrected QT (QTc) prolongation (\> 500 ms)
* Heart failure exacerbation at the time of enrollment
Source: ClinicalTrials.gov (NCT01949662). StuddyBuddy aggregates publicly available trial information.