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Can a common antipsychotic combo calm delirium in dying cancer patients?

NCT ID NCT03021486

Symptom relief Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tests whether giving haloperidol alone or with chlorpromazine can safely calm severe agitation and confusion (delirium) in 70 advanced cancer patients in a palliative care unit. The main goal is to see if the drugs improve sedation scores within 24 hours. It is a phase 2/3 trial run by M.D. Anderson Cancer Center.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Haloperidol and chlorpromazine (antipsychotic drugs given intravenously)
What this could lead to
If it works, this could provide a better way to quickly calm severe confusion and agitation in cancer patients nearing the end of life.
What could go wrong
This is a small, early-stage trial in a very specific hospital setting, so results may not apply broadly. The drugs can cause side effects like oversedation or heart rhythm changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

70 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (\</=8 mg in the past 24 h) or rescue 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

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Conditions

The condition(s) this trial relates to.

cancer delirium metastatic malignant neoplasm Neoplasm Metastasis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced malignant neoplasm Delirium Locally advanced malignant neoplasm Metastatic malignant neoplasm Recurrent malignant neoplasm

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

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