Advanced CancersPhase 2NCT01949662

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

A Phase 2 study testing Lorazepam, Haloperidol decanoate and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancers
What is being tested?: Lorazepam, Haloperidol decanoate and Questionnaires
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 93 participants
Where: 1 siteUnited States
Study dates: Jan 2014to 1 Jan 2028
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit

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.

Read the detailed description

PRIMARY OBJECTIVES:

To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on the intensity of agitation (Richmond Agitation Sedation Scale) over 8 hours.

II. To assess the within-arm effect of single-dose lorazepam or placebo, as an adjuvant agent with haloperidol, on agitation intensity (Richmond Agitation Sedation Scale) over 8 hours in patients admitted to an acute palliative care unit.

SECONDARY OBJECTIVES:

To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on (1) delirium related distress in nurses and caregivers, (2) delirium duration, (3) need for rescue doses of neuroleptics, (4) delirium recall, (5) symptom expression (Edmonton Symptom Assessment Scale), (6) communicative capacity, (7) adverse effects, (8) discharge outcomes, and (9) survival in cancer patients.

II. To evaluate proportion of patients who consent and are randomized to study however drop out before being treated or before finishing 8-hour Richmond Agitation Sedation Scale (RASS) assessment; and the reasons of drop-outs will be documented and reported.

III. To explore the changes in biomarker levels in saliva samples (salivary cortisol, cholinesterase, C-reactive protein, interleukin-1 beta, -6, and -10) over time and in association with delirium severity.

IV. To examine the inter-rater reliability of RASS in the Acute Palliative Care Unit (APCU) setting between the bedside nurse and the research nurse at the time of study enrollment.

To conduct exploratory analyses on RASS as an outcome. VI. To examine the association among rescue medication use, RASS and perceived comfort by the nurses and caregivers.

VII. To examine the proportion of patients enrolled onto the delirium trial who achieved control of agitation and did not require the randomized study medication.

VIII. To identify patient factors associated with control of agitated delirium.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lorazepam intravenously (IV) over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

ARM II: Patients receive placebo IV over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

Conditions: Advanced Cancers
Being tested: Lorazepam, Placebo, Haloperidol decanoate, Questionnaires
Keywords: Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Neurotoxicity Syndrome, Questionnaires, Surveys, Acute palliative care unit
Medical subject headings: Delirium, Hematologic Neoplasms, Neurotoxicity Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LorazepamDrug
3 mg by vein one time only.
PlaceboDrug
Placebo consisting of preservative free 0.9% normal saline given one time by vein.
Haloperidol decanoateDrug
8 mg/day by vein.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.

Study groups in NCT01949662
Study group	Role	What they receive
Lorazepam + Haloperidol	Experimental	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 Receives: Drug: Lorazepam; Drug: Haloperidol decanoate; Behavioral: Questionnaires
Placebo + Haloperidol	Active comparator	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 Receives: Drug: Placebo; Drug: Haloperidol decanoate; Behavioral: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Measured: Baseline to 8 hours
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Measured: 8 hours

Secondary outcomes (2)

Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min
Change in Richmond Agitation-Sedation Scale score from baseline to 30 min. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Measured: Baseline to 30 minutes
Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr
Number of participants with Richmond Agitation-Sedation Scale score >=1 within 8 hr. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Measured: Baseline to 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20141 Jan 2028

First posted24 Sep 2013 (estimated)
Study startJan 2014
Primary completion26 Aug 2016
Study completion1 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced CancersStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01949662
Sponsor's protocol ID: 2013-0345
Other IDs: NCI-2013-02351, 1R21CA186000-01A1
Status last verified: Jul 2026
First submitted: 20 Sep 2013
Last updated: 17 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Hui D, Frisbee-Hume S, Wilson A, Dibaj SS, Nguyen T, De La Cruz M, Walker P, Zhukovsky DS, Delgado-Guay M, Vidal M, Epner D, Reddy A, Tanco K, Williams J, Hall S, Liu D, Hess K, Amin S, Breitbart W, Bruera E. Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1047-1056. doi: 10.1001/jama.2017.11468.
PubMed 28975307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit
ClinicalTrials.gov ID: NCT01949662
Acronym / sponsor ID: 2013-0345
Conditions: Advanced Cancers
Keywords: Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Neurotoxicity Syndrome, Questionnaires, Surveys
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 93 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jan 2014 (actual)
Primary completion: 26 Aug 2016 (actual)
Study completion: 1 Jan 2028 (estimated)
First posted: 24 Sep 2013 (estimated)
Results: Posted 30 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on the intensity of agitation (Richmond Agitation Sedation Scale) over 8 hours.

SECONDARY OBJECTIVES:

To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on (1) delirium related distress in nurses and caregivers, (2) delirium duration, (3) need for rescue doses of neuroleptics, (4) delirium recall, (5) symptom expression (Edmonton Symptom Assessment Scale), (6) communicative capacity, (7) adverse effects, (8) discharge outcomes, and (9) survival in cancer patients.

IV. To examine the inter-rater reliability of RASS in the Acute Palliative Care Unit (APCU) setting between the bedside nurse and the research nurse at the time of study enrollment.

To conduct exploratory analyses on RASS as an outcome. VI. To examine the association among rescue medication use, RASS and perceived comfort by the nurses and caregivers.

VII. To examine the proportion of patients enrolled onto the delirium trial who achieved control of agitation and did not require the randomized study medication.

VIII. To identify patient factors associated with control of agitated delirium.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lorazepam intravenously (IV) over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

ARM II: Patients receive placebo IV over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lorazepam + Haloperidol	Experimental	Drug: Lorazepam, Drug: Haloperidol decanoate, Behavioral: QuestionnairesParticipants 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
Placebo + Haloperidol	Active comparator	Drug: Placebo, Drug: Haloperidol decanoate, Behavioral: QuestionnairesParticipants 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lorazepam3 mg by vein one time only.	Drug	Lorazepam + Haloperidol
PlaceboPlacebo consisting of preservative free 0.9% normal saline given one time by vein.	Drug	Placebo + Haloperidol
Haloperidol decanoate8 mg/day by vein.	Drug	Lorazepam + Haloperidol, Placebo + Haloperidol
QuestionnairesAlso: SurveysQuestionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.	Behavioural	Lorazepam + Haloperidol, Placebo + Haloperidol

Primary outcome

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
Time frame: Baseline to 8 hours
The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
Time frame: 8 hours
Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

2 secondary outcomes

Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min
Time frame: Baseline to 30 minutes
Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr
Time frame: Baseline to 8 hours

Results and safety

Results posted to the registry on 30 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group (Lorazepam & Haloperidol)	47	29
Control Group (Placebo & Haloperidol)	43	29

Primary outcome: Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points

Time frame: Baseline to 8 hours. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Intervention Group (Lorazepam & Haloperidol) n = 26	Control Group (Placebo & Haloperidol) n = 26
Value	-4.1 (-4.8 to -3.4)	-2.3 (-2.9 to -1.6)

Population analysed: Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm.

Primary outcome: Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points

Time frame: 8 hours. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Intervention Group (Lorazepam & Haloperidol) n = 26	Control Group (Placebo & Haloperidol) n = 26
Value	-2.5 (-3.2 to -1.9)	-0.7 (-1.3 to -0.1)

Population analysed: Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 3 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group (Lorazepam & Haloperidol)	0 of 29 (0%)	3 of 29 (10.3%)	10 of 47
Control Group (Placebo & Haloperidol)	0 of 29 (0%)	4 of 29 (13.8%)	10 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28975307Hui D, Frisbee-Hume S, Wilson A, Dibaj SS, Nguyen T, De La Cruz M, Walker P, Zhukovsky DS, Delgado-Guay M, Vidal M, Epner D, Reddy A, Tanco K, Williams J, Hall S, Liu D, Hess K, Amin S, Breitbart W, Bruera E. Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1047-1056. doi: 10.1001/jama.2017.11468.
University of Texas MD Anderson Cancer CenterLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Hui, MD principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lorazepam, Haloperidol decanoate and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points (time frame: Baseline to 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.