Clinical trial · Interventional
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haloperidol decanoate | Drug | — | UNRESOLVED |
| Lorazepam | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lorazepam + Haloperidol
- description
- Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
- interventionNames
- Drug: Lorazepam
- Drug: Haloperidol decanoate
- Behavioral: Questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Placebo + Haloperidol
- description
- Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
- interventionNames
- Drug: Placebo
- Drug: Haloperidol decanoate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHui D, Frisbee-Hume S, Wilson A, Dibaj SS, Nguyen T, De La Cruz M, Walker P, Zhukovsky DS, Delgado-Guay M, Vidal M, Epner D, Reddy A, Tanco K, Williams J, Hall S, Liu D, Hess K, Amin S, Breitbart W, Bruera E. Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1047-1056. doi: 10.1001/jama.2017.11468. PMID 28975307