Clinical trial · Interventional
Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care
Strategies for Persistent Agitated Delirium in Palliative Care
NCT03743649CI-TRIAL-00114801active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Delirium | — | UNRESOLVED | — |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haloperidol | Drug | — | UNRESOLVED |
| Lorazepam | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group I (haloperidol, placebo)
- description
- Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
- interventionNames
- Drug: Haloperidol
- Other: Placebo
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Group II (lorazepam, placebo)
- description
- Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
- interventionNames
- Drug: Lorazepam
- Other: Placebo
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease) 2. \[Patients\] Admitted to the acute palliative care unit‡ 3. \[Patients\] Delirium as per DSM-5 criteria 4. \[Patients\] Hyperactive or mixed delirium with RASS ≥1\* in the past 24 h despite efforts to treat potential underlying causes 5. \[Patients\] On scheduled haloperidol for delirium (≤8 mg in the past 24 h) or required ≥4 mg of rescue haloperidol for agitation in the past 24 h 6. \[Patients\] Age 18 years or older 7. \[Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (partner as defined by patient) 8. \[Caregivers\] Age 18 years or older Exclusion Criteria: 1. \[Patients\] History of myasthenia gravis or acute narrow angle glaucoma 2. \[Patients\] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week) 3. \[Patients\] History of Parkinson's disease, Alzheimer's or Lewy body dementia 4. \[Patients\] History of prolonged QTc or QTcF interval (\>500 ms)† if documented by most recent ECG within the past month 5. \[Patients\] History of hypersensitivity to haloperidol or lorazepam 6. \[Patients\] On scheduled lorazepam within the past 48 h
References
Publications (1)
- DERIVEDHui D, De La Rosa A, Tsai JS, Cheng SY, Del Fabbro E, Thomas Kuzhiyil AT, Rowe K, Azhar A, Nguyen T, Tang M, Yao CA, Huang HL, Peng JK, Hu WY, Admane S, Dev R, Chen M, Bramati P, Shete S, Bruera E. Proportional Sedation for Persistent Agitated Delirium in Palliative Care: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1031-1043. doi: 10.1001/jamaoncol.2025.2212. PMID 40742738