Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Delirium, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT03743649

Run by

M.D. Anderson Cancer Center

People needed

110

Starts

2019-07-17

Expected to finish

2028-12-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• [Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
• [Patients] Admitted to the acute palliative care unit‡
• [Patients] Delirium as per DSM-5 criteria
• [Patients] Hyperactive or mixed delirium with RASS ≥1* in the past 24 h despite efforts to treat potential underlying causes
• [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
• [Patients] Age 18 years or older
• [Caregivers] Patient's spouse, adult child, sibling, parent, other relative, or significant other (partner as defined by patient)
• [Caregivers] Age 18 years or older

You may not qualify if…

• [Patients] History of myasthenia gravis or acute narrow angle glaucoma
• [Patients] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
• [Patients] History of Parkinson's disease, Alzheimer's or Lewy body dementia
• [Patients] History of prolonged QTc or QTcF interval (>500 ms)† if documented by most recent ECG within the past month
• [Patients] History of hypersensitivity to haloperidol or lorazepam
• [Patients] On scheduled lorazepam within the past 48 h

Where it is running

• 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

Full record on ClinicalTrials.gov

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