Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

NCT01949662 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2013-0345NCI-2013-023511R21CA186000-01A1
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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; Acute palliative care unit

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 hours

Secondary Outcomes (2)

• Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min

  Baseline to 30 minutes

• Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr

  Baseline to 8 hours

Study Arms (2)

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

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

Drug: Placebo; Drug: Haloperidol decanoate; Behavioral: Questionnaires

Interventions

Lorazepam DRUG

3 mg by vein one time only.

Lorazepam + Haloperidol

Placebo DRUG

Placebo consisting of preservative free 0.9% normal saline given one time by vein.

Placebo + Haloperidol

Haloperidol decanoate DRUG

8 mg/day by vein.

Lorazepam + Haloperidol; Placebo + Haloperidol

Questionnaires BEHAVIORAL

Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.

Also known as: Surveys

Lorazepam + Haloperidol; Placebo + Haloperidol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28975307 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Delirium; Hematologic Neoplasms; Neurotoxicity Syndromes

Interventions

Lorazepam; haloperidol decanoate; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: David Hui, MD/ Associate Professor, Palliative Care Medicine
• Organization: UT MD Anderson Cancer Center

dhui@mdanderson.org

713-792-6258

Study Officials

• David Hui, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: January 1, 2014
• Primary Completion: August 26, 2016
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 13, 2026
• Results First Posted: October 30, 2020

Record last verified: 2026-01

Locations

US (1)