Haloperidol +/- Chlorpromazine for Delirium in Cancer Patients

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced cancer experiencing delirium, who are admitted to the acute palliative care unit. They must have a diagnosis of hyperactive or mixed delirium and be on haloperidol treatment. Excluded are those with neuroleptic malignant syndrome, seizure disorders, Parkinson's disease, Alzheimer's dementia, hypersensitivity to the drugs being tested, myasthenia gravis, glaucoma or a prolonged QTc interval.

Inclusion Criteria

I am currently admitted to a palliative care unit.

The patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)

My cancer is advanced and cannot be cured with surgery or radiation alone.

Exclusion Criteria

I have had a seizure in the last week or a history of neuroleptic malignant syndrome.

You have had a bad reaction to haloperidol or chlorpromazine in the past.

I have taken chlorpromazine in the last 48 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive haloperidol and/or chlorpromazine intravenously every 4 hours to manage delirium symptoms

24 hours

Continuous monitoring in the acute palliative care unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

Daily assessments

Treatment Details

Interventions

• Chlorpromazine
• Haloperidol

Trial Overview The study is testing whether adding chlorpromazine to haloperidol is more effective in treating delirium symptoms in patients with advanced cancer than using haloperidol alone. It's a randomized trial where patients will either receive both medications or just haloperidol while their quality of life and symptom changes are monitored.

Participant Groups

Group I: Group III (haloperidol, chlorpromazine) Experimental Treatment 4 Interventions

Patients receive haloperidol and chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.

Group II: Group II (chlorpromazine) Experimental Treatment 3 Interventions

Patients receive chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.

Group III: Group I (haloperidol) Experimental Treatment 3 Interventions

Patients receive haloperidol IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.

Haloperidol is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium

Approved in European Union as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium
• Tourette's syndrome

Approved in Canada as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium

Approved in Japan as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+