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Can a calming drug combo bring clarity to cancer patients?

NCT ID NCT01949662

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study looks at whether adding lorazepam to haloperidol can better reduce delirium (sudden confusion and agitation) in people with advanced cancer who are in a palliative care unit. About 93 participants will receive either haloperidol alone or with lorazepam, and their level of calmness and alertness will be measured. The goal is to help patients feel more comfortable and less distressed.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

93 people

The number who actually took part.

Started

Jan 2014

Expected to finish

Jan 2028

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 Criteria: * PATIENTS: * Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease) * Admitted to Acute Palliative Care Unit (APCU) * Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV- TR) criteria * Hyperactive/mixed delirium with RASS \>= 2 in the last 24 hours * On scheduled haloperidol of =\< 8 mg in the last 24 hours * Legally authorized representative consent * FAMILY CAREGIVERS: * Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner) * Age 18 or older * At the patient's bedside at least 4 hours each day during patient delirium episode * Patients and family caregivers able to communicate in English or Spanish Exclusion Criteria: * PATIENTS * History of myasthenia gravis or acute narrow angle glaucoma * History of neuroleptic malignant syndrome * History of Parkinson's disease or dementia * Uncontrolled seizure disorder * History of hypersensitivity to haloperidol or benzodiazepine * On regular doses of benzodiazepine or chlorpromazine within the past 48 hours * Previously documented and persistent corrected QT (QTc) prolongation (\> 500 ms) * Heart failure exacerbation at the time of enrollment

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Conditions

The condition(s) this trial relates to.

cancer delirium hematopoietic and lymphoid system neoplasm toxic encephalopathy

As listed by the trial registrant

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

Advanced cancers

Contacts and locations

Locations

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.