93 Participants Needed

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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12467

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.12468

Who Is on the Research Team?

David Hui | MD Anderson Cancer Center

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.
See 6 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Lorazepam + HaloperidolExperimental Treatment3 Interventions
Group II: Placebo + HaloperidolActive Control3 Interventions

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

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Approved in United States as Haldol for:
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Approved in European Union as Haldol for:
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Approved in Canada as Haldol for:
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Approved in Japan as Haldol for:

Find a Clinic Near You

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+

Citations

Emergency intravenous sedation of the delirious, medically ill patient. [2013]
Usage of haloperidol for delirium in cancer patients. [2022]
Olanzapine Versus Haloperidol for Treatment of Delirium in Patients with Advanced Cancer: A Phase III Randomized Clinical Trial. [2021]
Acute confusional states in patients with advanced cancer. [2019]
Delirium in advanced cancer patients. [2017]
Concerns over haloperidol for treating delirium in older people. [2022]
Haloperidol for the treatment of delirium in critically ill patients: an updated systematic review with meta-analysis and trial sequential analysis. [2023]
Delirium in cancer patients. [2019]
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