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Haloperidol and/or Chlorpromazine for Refractory Agitated Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03021486
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if chlorpromazine, high-dose haloperidol, or a combination of the 2 drugs can help to control the symptoms of delirium (loss of contact with reality) in patients with advanced cancer who did not respond to low-dose haloperidol. High-dose haloperidol doses are usually about 2-4 times the size of low-dose haloperidol.

In addition, researchers want to learn if treating patients with these drugs can help to lessen any distress that their caregivers may be having.

The safety of these drugs will also be studied.

This is an investigational study. Both chlorpromazine and haloperidol are FDA approved and commercially available for the treatment of bipolar disorder and psychotic disorders. Their use to help control delirium is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Independent (Primary) Multiple Sites Drug: Haloperidol Drug: Chlorpromazine Behavioral: Symptom Questionnaire Phase 2 Phase 3

Detailed Description:

Study Groups:

If you are found to be eligible and agree to take part, you will be randomly assigned (as in a roll of the dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being in each group.

  • If you are in Group 1, you will receive haloperidol.
  • If you are in Group 2, you will receive chlorpromazine.
  • If you are in Group 3, you will receive haloperidol and chlorpromazine.

Neither you nor the study staff will know which study drug you are receiving. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

You will receive the study drug(s) by vein over about 3-15 minutes every 4 hours until you are discharged from the palliative care unit or you withdraw from the study. You may receive additional doses every 1 hour, if needed. The dose level and length of administration may be raised or lowered to meet your needs.

Length of Treatment:

You may continue receiving the study drug(s) for as long as you are in the palliative care unit. You may stop receiving the study drug(s) at any time that you and/or your caregiver decides it is in your best interest.

Baseline Procedures:

Before your first dose of the study drug(s):

  • Your demographic information (such as age, sex, date of birth, race, marital status, and education), medical information, and cancer history will be recorded.
  • You will complete a test to measure your level of delirium. To complete this test, the study doctor will ask you to complete several thinking tasks, such as recalling a set of numbers or words, remembering different objects, and stating what day it is. This test should take less than 10 minutes to complete.
  • You will complete 1 questionnaire about any symptoms you may be having. This should take about 5 minutes to complete.

Study Procedures:

Every 8 hours during the first 24 hours that you are in the palliative care unit, you will repeat the symptoms questionnaire. After the first 24 hours, you will complete the questionnaire 1 time each day until you are discharged.

If and when you recover from the delirium, you will be asked to complete a questionnaire about your experience with delirium. This should take about 5 minutes to complete. Your active participation on this study will be over at that point.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Haloperidol and/or Chlorpromazine for Refractory Agitated Delirium in the Palliative Care Unit
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Haloperidol Group

All participants receive Haloperidol 2 mg by vein every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If Richmond Agitation Sedation Scale (RASS) scores reach ≥+2, participant randomized to Haloperidol 2 mg by vein every 4 hours and every hour as needed.

Symptom questionnaire completed at baseline and every 8 hours during the first 24 hours in the palliative care unit. After the first 24 hours, questionnaire completed 1 time each day until discharge.

Drug: Haloperidol

All participants receive Haloperidol 2 mg by vein every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If Richmond Agitation Sedation Scale (RASS) scores reach ≥+2, participant randomized.

Haloperidol Group: Haloperidol 2 mg by vein every 4 hours and every hour as needed.

Haloperidol and Chlorpromazine Group: Haloperidol 1 mg by vein every 4 hours and every hour as needed,


Behavioral: Symptom Questionnaire
Symptom questionnaire completed at baseline and every 8 hours during the first 24 hours in the palliative care unit. After the first 24 hours, questionnaire completed 1 time each day until discharge.
Other Name: Survey

Experimental: Chlorpromazine Group

All participants receive Haloperidol 2 mg by vein every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If Richmond Agitation Sedation Scale (RASS) scores reach ≥+2, participant randomized to Chlorpromazine 25 mg by vein every 4 hours and every hour as needed.

Symptom questionnaire completed at baseline and every 8 hours during the first 24 hours in the palliative care unit. After the first 24 hours, questionnaire completed 1 time each day until discharge.

Drug: Haloperidol

All participants receive Haloperidol 2 mg by vein every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If Richmond Agitation Sedation Scale (RASS) scores reach ≥+2, participant randomized.

Haloperidol Group: Haloperidol 2 mg by vein every 4 hours and every hour as needed.

Haloperidol and Chlorpromazine Group: Haloperidol 1 mg by vein every 4 hours and every hour as needed,


Drug: Chlorpromazine

Chlorpromazine Group: After randomization, Chlorpromazine 25 mg by vein every 4 hours and every hour as needed.

Haloperidol and Chlorpromazine Group: Chlorpromazine 12.5 mg by vein every 4 hours and every hour as needed.

Other Names:
  • Chlorpromazine hydrochloride
  • Thorazine

Behavioral: Symptom Questionnaire
Symptom questionnaire completed at baseline and every 8 hours during the first 24 hours in the palliative care unit. After the first 24 hours, questionnaire completed 1 time each day until discharge.
Other Name: Survey

Experimental: Haloperidol and Chlorpromazine Group

All participants receive Haloperidol 2 mg by vein every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If Richmond Agitation Sedation Scale (RASS) scores reach ≥+2, participant randomized to Haloperidol 1 mg by vein every 4 hours and every hour as needed, and Chlorpromazine 12.5 mg by vein every 4 hours and every hour as needed.

Symptom questionnaire completed at baseline and every 8 hours during the first 24 hours in the palliative care unit. After the first 24 hours, questionnaire completed 1 time each day until discharge.

Drug: Haloperidol

All participants receive Haloperidol 2 mg by vein every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If Richmond Agitation Sedation Scale (RASS) scores reach ≥+2, participant randomized.

Haloperidol Group: Haloperidol 2 mg by vein every 4 hours and every hour as needed.

Haloperidol and Chlorpromazine Group: Haloperidol 1 mg by vein every 4 hours and every hour as needed,


Drug: Chlorpromazine

Chlorpromazine Group: After randomization, Chlorpromazine 25 mg by vein every 4 hours and every hour as needed.

Haloperidol and Chlorpromazine Group: Chlorpromazine 12.5 mg by vein every 4 hours and every hour as needed.

Other Names:
  • Chlorpromazine hydrochloride
  • Thorazine

Behavioral: Symptom Questionnaire
Symptom questionnaire completed at baseline and every 8 hours during the first 24 hours in the palliative care unit. After the first 24 hours, questionnaire completed 1 time each day until discharge.
Other Name: Survey




Primary Outcome Measures :
  1. Agitation Intensity in Participants Admitted to an Acute Palliative Care Unit Who Did Not Experience a Response to Low-Dose Haloperidol [ Time Frame: 24 hours ]
    Agitation intensity measured by Richmond Agitation Sedation Scale (RASS).


Secondary Outcome Measures :
  1. Proportion of Patients with Target Richmond Agitation Sedation Scale (RASS) -2 to 0 [ Time Frame: 24 hours and 48 hours ]
  2. Delirium-Related Distress in Nurses and Caregivers Measured by Delirium Experience Questionnaire [ Time Frame: 24 hours and 48 hours ]
  3. Symptom Expression Measured by Edmonton Symptom Assessment Scale [ Time Frame: 24 hours ]
  4. Delirium Severity Measured by Memorial Delirium Assessment Scale [ Time Frame: 24 hours and 48 hours ]
  5. Proportion of Patients Taking Neuroleptics [ Time Frame: 24 hours and 48 hours ]
  6. Adverse Effects Related to the Use of Neuroleptics Documented Using NCI CTCAE v4.03 [ Time Frame: 24 hours ]
  7. Feasibility of novel measures for the assessment of agitation with continuous video monitoring. [ Time Frame: 24 hours ]
    Feasibility defined as >50% of family caregivers accepting this optional video monitoring procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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
  9. [Family Caregivers] At the patient's bedside at least 4 h/day

Exclusion Criteria:

  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)
  5. [Patients] History of hypersensitivity to haloperidol or chlorpromazine
  6. [Patients] On scheduled chlorpromazine within the past 48 h

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021486


Contacts
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Contact: David Hui, MD 713-792-6085 dhui@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       dhui@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: David Hui, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03021486     History of Changes
Other Study ID Numbers: 2016-0687
1R21NR016736-01 ( U.S. NIH Grant/Contract )
NCI-2017-01065 ( Registry Identifier: NCI-CTRP )
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of independent (primary) multiple sites
Haloperidol
Chlorpromazine
Chlorpromazine hydrochloride
Thorazine
Symptom questionnaire
Survey
Delirium
Acute palliative care unit
APCU

Additional relevant MeSH terms:
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Delirium
Neoplasms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol
Chlorpromazine
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents