Clinical trial · Interventional
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
Haloperidol and/or Chlorpromazine for Refractory Agitated Delirium in the Palliative Care Unit
NCT03021486CI-TRIAL-00105906active not recruitingPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This randomized phase II/III trial studies how well haloperidol with or without chlorpromazine works in treating delirium in patients with cancer that has spread to other parts of the body or has come back. Haloperidol and chlorpromazine may control the symptoms of delirium (loss of contact with reality) in patients with cancer.
Conditions
Conditions (5)
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 Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorpromazine | Drug | — | UNRESOLVED |
| Haloperidol | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I (haloperidol)
- description
- Patients receive haloperidol IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
- interventionNames
- Drug: Haloperidol
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Group II (chlorpromazine)
- description
- Patients receive chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
- interventionNames
- Drug: Chlorpromazine
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: 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-V criteria (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)) 4. \[Patients\] Hyperactive or mixed delirium with RASS \>/=1 in the past 24 h (RASS\>/=+1 indicates any degree of restlessness. In the electronic medical record nursing note, this behavior would be indicated by any documentation of "restless", "agitated", "hyperactive", "pulling on devices/IV" or similar wording). 5. \[Patients\] On scheduled haloperidol for delirium (\</=8 mg in the past 24 h) or rescue haloperidol of \>/=4 mg for restlessness/agitation in the past 24 h 6. \[Patients\] Age 18 years or older 7. \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner) 8. \[Family Caregivers\] Age 18 years or older Exclusion: 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 or Alzheimer's dementia 4. \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by ECG within the past month 5. \[Patients\] History of hypersensitivity to haloperidol or chlorpromazine 6. \[Patients\] On scheduled chlorpromazine within the past 48 h
References
Publications (1)
- DERIVEDHui D, De La Rosa A, Wilson A, Nguyen T, Wu J, Delgado-Guay M, Azhar A, Arthur J, Epner D, Haider A, De La Cruz M, Heung Y, Tanco K, Dalal S, Reddy A, Williams J, Amin S, Armstrong TS, Breitbart W, Bruera E. Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial. Lancet Oncol. 2020 Jul;21(7):989-998. doi: 10.1016/S1470-2045(20)30307-7. Epub 2020 May 29. PMID 32479786