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

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.

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