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

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Haloperidol; Haloperidol decanoate; Lorazepam

Criteria

Inclusion Criteria:

• 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 Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria

• PATIENTS: Hyperactive or mixed delirium with RASS >= 1 in the past 24 hours (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

• CAREGIVERS: Patient's spouse, adult child, sibling, parent, other relative, or significant other (partner as defined by patient)

Exclusion Criteria:

• PATIENTS: History of myasthenia gravis, acute narrow angle glaucoma, or hepatic encephalopathy

• 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 corrected QT (QTc) or corrected QT interval by Fredericia (QTcF) interval (> 500ms) if documented by electrocardiogram (ECG) within the past month

• PATIENTS: History of hypersensitivity to haloperidol or lorazepam

• PATIENTS: On scheduled lorazepam within the past 48 hours