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Antipsychotic
Haloperidol + Lorazepam for Cancer-related Delirium
Phase 2 & 3
Recruiting
Led By David Hui
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
Admitted to the acute palliative care unit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-8 weeks
Awards & highlights
Study Summary
This trial studies haloperidol and lorazepam to see how well they work in controlling symptoms of delirium in cancer patients undergoing palliative care.
Who is the study for?
This trial is for adults with advanced cancer experiencing persistent agitated delirium, despite treatment efforts. They must be admitted to a palliative care unit and have been on haloperidol or required it for agitation. Excluded are those with certain neurological disorders, history of severe reactions to the drugs being tested, or specific heart rhythm abnormalities.Check my eligibility
What is being tested?
The study examines if haloperidol and lorazepam can effectively manage symptoms of agitated delirium in patients undergoing palliative care for advanced cancer. It also looks at how these medications might affect the well-being of caregivers.See study design
What are the potential side effects?
Haloperidol may cause muscle stiffness, drowsiness, restlessness, and tremors. Lorazepam could lead to sedation, weakness, unsteadiness, memory issues or confusion. Both drugs carry a risk of worsening delirium in some cases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be cured with surgery or radiation.
Select...
I am currently in a hospital's palliative care unit.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU)
Secondary outcome measures
Delirium severity assessed using Memorial Delirium Assessment Scale
Delirium-related distress in caregivers and nurses assessed using Delirium Experience Questionnaire
Incidence of adverse events
+7 moreSide effects data
From 2016 Phase 4 trial • 35 Patients • NCT0219974321%
Sedation
21%
Insomnia
14%
Stiffness in jaw
7%
diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lurasidone (LUR)
NONLUR
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group IV (placebo, lorazepam)Experimental Treatment4 Interventions
Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
Group II: Group III (haloperidol, lorazepam)Experimental Treatment4 Interventions
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
Group III: Group II (lorazepam, placebo)Experimental Treatment4 Interventions
Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
Group IV: Group I (haloperidol, placebo)Experimental Treatment4 Interventions
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Haloperidol
FDA approved
Lorazepam
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,648 Previous Clinical Trials
40,931,534 Total Patients Enrolled
5 Trials studying Delirium
1,258 Patients Enrolled for Delirium
M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,711 Total Patients Enrolled
6 Trials studying Delirium
638 Patients Enrolled for Delirium
David HuiPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,831 Total Patients Enrolled
1 Trials studying Delirium
70 Patients Enrolled for Delirium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity (measured by ECG) has shown a specific abnormality called prolonged QTc interval in the last month.You have had a bad reaction to haloperidol or lorazepam in the past.I have taken up to 8 mg of haloperidol for delirium or needed at least 4 mg for agitation recently.I have a history of myasthenia gravis or acute narrow angle glaucoma.My cancer is advanced and cannot be cured with surgery or radiation.I am currently in a hospital's palliative care unit.I have a close family member or partner involved.I am 18 years old or older.You have had severe confusion and agitation in the past day, even after trying to treat the possible reasons for it.I have had a seizure in the last week or a history of neuroleptic malignant syndrome.I have taken lorazepam as prescribed in the last 48 hours.You have delirium, as determined by specific medical guidelines.I have a history of Parkinson's, Alzheimer's, or Lewy body dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (haloperidol, placebo)
- Group 2: Group II (lorazepam, placebo)
- Group 3: Group IV (placebo, lorazepam)
- Group 4: Group III (haloperidol, lorazepam)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions does Haloperidol typically alleviate?
"Haloperidol can be used to manage the care of patients with schizophrenia, phencyclidine, and palliative care."
Answered by AI
Are there other research papers which mention Haloperidol?
"Haloperidol was first studied in 2012 at the Chaim Sheba Medical Center. There have been a total of 18,586 completed trials as of now. There are 13 studies that are still recruiting, with a high concentration in Richmond, Virginia."
Answered by AI
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