Haloperidol + Lorazepam for Delirium in Advanced Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Haloperidol

Must not be taking: Benzodiazepines, Chlorpromazine

Disqualifiers: Myasthenia gravis, Glaucoma, Parkinson's, others

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: 8 hours

93 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.

Will I have to stop taking my current medications?

The trial requires that you have not taken regular doses of benzodiazepine or chlorpromazine in the past 48 hours. If you are on these medications, you may need to stop them before participating.

What data supports the effectiveness of the drug combination of Haloperidol and Lorazepam for treating delirium in advanced cancer patients?

Research shows that a combination of Haloperidol and Lorazepam has been used to safely and effectively sedate over 2,000 medically ill cancer patients with delirium, providing rapid symptom relief even in emergency situations. ^{1 2 3 4 5}

Is the combination of haloperidol and lorazepam safe for treating delirium in advanced cancer patients?

Research involving over 2,000 cancer patients with delirium shows that the combination of haloperidol and lorazepam is generally safe, even in critically ill patients, when used for emergency sedation. This combination allows for lower doses of haloperidol and has been used safely for up to 15 days. ^{1 2 3 6 7}

How does the drug combination of Haloperidol and Lorazepam differ from other treatments for delirium in advanced cancer patients?

The combination of Haloperidol and Lorazepam is unique because it provides rapid and safe sedation for delirium in advanced cancer patients, especially in emergency situations, by using lower doses of Haloperidol. This approach is particularly effective for patients with severe symptoms and is considered ideal for managing intractable pain in terminally ill cancer patients. ^{1 2 3 4 8}

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 in a palliative care unit and have had hyperactive or mixed symptoms recently. They must be on low-dose haloperidol and not have conditions like myasthenia gravis, glaucoma, Parkinson's disease, dementia, uncontrolled seizures, or certain heart issues.

Inclusion Criteria

I have a close family member or partner involved.

I have experienced severe confusion or agitation recently.

I have been diagnosed with delirium.

Exclusion Criteria

I am allergic to haloperidol or benzodiazepines.

I have taken benzodiazepine or chlorpromazine regularly in the last 48 hours.

My heart failure is not getting worse right now.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either lorazepam or placebo with haloperidol to assess the effect on delirium over an 8-hour period

8 hours

Continuous monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

Daily assessments in the palliative care unit

Treatment Details

Interventions

• Haloperidol
• Lorazepam

Trial Overview The study is testing if adding lorazepam to haloperidol can better reduce delirium symptoms in patients with advanced cancer compared to using just haloperidol. Participants will be randomly assigned to receive either both drugs or only haloperidol alongside a placebo.

Participant Groups

Group I: Lorazepam + Haloperidol Experimental Treatment 3 Interventions

Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete

Group II: Placebo + Haloperidol Active Control 3 Interventions

Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete

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 Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Emergency intravenous sedation of the delirious, medically ill patient. [2013]

2. Germany pubmed.ncbi.nlm.nih.gov

Usage of haloperidol for delirium in cancer patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Olanzapine Versus Haloperidol for Treatment of Delirium in Patients with Advanced Cancer: A Phase III Randomized Clinical Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acute confusional states in patients with advanced cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Delirium in advanced cancer patients. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Concerns over haloperidol for treating delirium in older people. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Haloperidol for the treatment of delirium in critically ill patients: an updated systematic review with meta-analysis and trial sequential analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Delirium in cancer patients. [2019]