Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer (NCT01949662) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
Timeframe: Baseline to 8 hours
2
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points