Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer

NCT03021486 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2016-0687NCI-2017-01065R21NR016736
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II/III trial studies how well haloperidol with or without chlorpromazine works in treating delirium in patients with cancer that has spread to other parts of the body or has come back. Haloperidol and chlorpromazine may control the symptoms of delirium (loss of contact with reality) in patients with cancer.

Conditions

Advanced Malignant Neoplasm; Delirium; Locally Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in Richmond Agitation Sedation Score (RASS) (0-24h)

  RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was mean change in RASS score between time 0 (immediately before initiation of masked treatment) and 24 h later. The Richmond Agitation-Sedation Scale (RASS) was developed by a multidisciplinary team at Virginia Commonwealth University in Richmond; it is a validated method used to avoid oversedation in the Intensive Care Unit.

  Time 0 or Baseline and 24 hours after study medication administration

Secondary Outcomes (10)

• Percentage of Participants With RASS Score -2 to 0

  Time 0 or Baseline and 24 hours later.

• Change in RASS Score (0-30 Minutes)

  Time 0 or Baseline and 30 minutes later.

• Number of Participants With RASS Score of >=1

  0 or Baseline and 24 hours later

• Pattern of Medication Use

  Baseline and 24 hours

• Perceived Comfort Level as Assessed by Caregiver

  Baseline and 24 hour

Study Arms (3)

Group I (haloperidol)

EXPERIMENTAL

Patients receive haloperidol IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.

Drug: Haloperidol; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (chlorpromazine)

EXPERIMENTAL

Patients receive chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.

Drug: Chlorpromazine; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (haloperidol, chlorpromazine)

EXPERIMENTAL

Patients receive haloperidol and chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.

Drug: Chlorpromazine; Drug: Haloperidol; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Chlorpromazine DRUG

Given IV

Also known as: Chlor-PZ, Thorazine

Group II (chlorpromazine); Group III (haloperidol, chlorpromazine)

Haloperidol DRUG

Given IV

Also known as: Haldol, McN-JR-1625, R 1625, R-1625

Group I (haloperidol); Group III (haloperidol, chlorpromazine)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (haloperidol); Group II (chlorpromazine); Group III (haloperidol, chlorpromazine)

Questionnaire Administration OTHER

Ancillary studies

Group I (haloperidol); Group II (chlorpromazine); Group III (haloperidol, chlorpromazine)

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)
• \[Patients\] Admitted to the acute palliative care unit
• \[Patients\] Delirium as per DSM-V criteria (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5))
• \[Patients\] 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).
• \[Patients\] 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
• \[Patients\] Age 18 years or older
• \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
• \[Family Caregivers\] Age 18 years or older

You may not qualify if:

• \[Patients\] History of myasthenia gravis or acute narrow angle glaucoma
• \[Patients\] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
• \[Patients\] History of Parkinson's disease or Alzheimer's dementia
• \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by ECG within the past month
• \[Patients\] History of hypersensitivity to haloperidol or chlorpromazine
• \[Patients\] On scheduled chlorpromazine within the past 48 h

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hui D, De La Rosa A, Wilson A, Nguyen T, Wu J, Delgado-Guay M, Azhar A, Arthur J, Epner D, Haider A, De La Cruz M, Heung Y, Tanco K, Dalal S, Reddy A, Williams J, Amin S, Armstrong TS, Breitbart W, Bruera E. Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial. Lancet Oncol. 2020 Jul;21(7):989-998. doi: 10.1016/S1470-2045(20)30307-7. Epub 2020 May 29.

  PMID: 32479786 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Delirium; Neoplasm Metastasis; Recurrence

Interventions

Chlorpromazine; Haloperidol

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neoplastic Processes; Neoplasms; Pathologic Processes; Disease Attributes

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones

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

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 16, 2017
• Study Start: June 5, 2017
• Primary Completion: June 5, 2021
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 18, 2026
• Results First Posted: September 1, 2022

Record last verified: 2026-03

Locations

US (1)