Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care
NCT ID: NCT03743649
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2019-07-17
2026-12-31
Brief Summary
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Detailed Description
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I. To compare the effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on the change in the Richmond Agitation Sedation Scale (RASS) score over 24 hours in patients admitted to an acute palliative care unit (APCU) who do not respond to low-dose haloperidol
Secondary Objectives:
I. To compare the effects of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on (1) rescue medication use; (2) the proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of ≥ 1.5 points); (3) perceived comfort as assessed by caregivers and bedside nurses; (4) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire); (5) achievement of the proxy comfort goal; (6) symptom expression (Edmonton Symptom Assessment Scale \[ESAS\]); (7) delirium severity (Memorial Delirium Assessment Scale \[MDAS\]); (8) adverse effects; and (9) quality of end-of-life care.
II. To identify novel predictive markers of response to haloperidol and lorazepam.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP I: Patients receive haloperidol intravenously (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.
GROUP II: 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.
GROUP III: Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP IV: Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Group I (haloperidol, placebo)
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.
Haloperidol
Given IV
Placebo
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group II (lorazepam, placebo)
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.
Lorazepam
Given IV
Placebo
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group III (haloperidol, lorazepam)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
Haloperidol
Given IV
Lorazepam
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group IV (placebo, lorazepam)
Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
Lorazepam
Given IV
Placebo
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Haloperidol
Given IV
Lorazepam
Given IV
Placebo
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Hui
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Hosptial de Cancer de Barretos
Barretos, São Paulo, Brazil
Countries
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References
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Hui 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.
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-02438
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0706
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0706
Identifier Type: -
Identifier Source: org_study_id