Active — Not RecruitingPhase 2

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

United States93 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points

Timeframe: Baseline to 8 hours

Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points

Timeframe: 8 hours

Trial details

NCT IDNCT01949662

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-26

Results submitted2020-09-15