Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if giving lorazepam in combination with haloperidol can help to control the symptoms of delirium in patients with advanced cancer. The safety of this drug combination will also be studied.

In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

• Phase: Phase 2
• 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:

1. [Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)

2. [Patients] Admitted to Acute Palliative Care Unit (APCU)

3. [Patients] Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria

4. [Patients] Hyperactive/mixed delirium with RASS >/=2 in the last 24 hours

5. [Patients] On scheduled haloperidol of

6. [Patients] Age 18 or older

7. [Patients] Legally Authorized Representative consent

8. [Family Caregivers] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)

9. [Family Caregivers] Age 18 or older

10. [Family Caregivers] At the patient's bedside at least 4 hours each day during patient delirium episode

11. [Patients and Family Caregivers] Able to communicate in English or Spanish

Exclusion Criteria:

1. [Patients] History of myasthenia gravis or acute narrow angle glaucoma

2. [Patients] History of neuroleptic malignant syndrome

3. [Patients] History of Parkinson's disease or dementia

4. [Patients] Uncontrolled seizure disorder

5. [Patients] History of hypersensitivity to haloperidol or benzodiazepine

6. [Patients] On regular doses of benzodiazepine or chlorpromazine within the past 48 hours

7. [Patients] Previously documented and persistent QTc prolongation (>500 ms)

8. [Patients] Heart failure exacerbation at the time of enrollment