Overview

Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer

Status:
Active, not recruiting

Trial end date:
2021-06-05

Target enrollment:
0

Participant gender:
All

Summary

This randomized phase II/III trial studies how well haloperidol with or without chlorpromazine works in treating delirium in patients with cancer that has spread to other parts of the body or has come back. Haloperidol and chlorpromazine may control the symptoms of delirium (loss of contact with reality) in patients with cancer.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborators:

National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)

Treatments:

Chlorpromazine
Haloperidol
Haloperidol decanoate

Criteria

Inclusion:

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-V criteria (The Diagnostic and Statistical Manual of
Mental Disorders, Fifth Edition (DSM-5))

4. [Patients] Hyperactive or mixed delirium with RASS >/=1 in the past 24 h (RASS>/=+1
indicates any degree of restlessness. In the electronic medical record nursing note,
this behavior would be indicated by any documentation of "restless", "agitated",
"hyperactive", "pulling on devices/IV" or similar wording).

5. [Patients] On scheduled haloperidol for delirium ( haloperidol of >/=4 mg for restlessness/agitation in the past 24 h

6. [Patients] Age 18 years or older

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

8. [Family Caregivers] Age 18 years or older

Exclusion:

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 or Alzheimer's dementia

4. [Patients] History of prolonged QTc interval (>500 ms) if documented by ECG within the
past month

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

6. [Patients] On scheduled chlorpromazine within the past 48 h