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Antipsychotic
Haloperidol + Lorazepam for Delirium in Advanced Cancer
Phase 2
Waitlist Available
Led By David Hui, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 30 minutes
Awards & highlights
Study Summary
This trial is testing how well haloperidol with or without lorazepam works to reduce delirium symptoms in patients with cancer that has spread and usually can't be cured or controlled.
Who is the study for?
This trial is for adults with advanced cancer experiencing delirium, who are in a palliative care unit and have had hyperactive or mixed symptoms recently. They must be on low-dose haloperidol and not have conditions like myasthenia gravis, glaucoma, Parkinson's disease, dementia, uncontrolled seizures, or certain heart issues.Check my eligibility
What is being tested?
The study is testing if adding lorazepam to haloperidol can better reduce delirium symptoms in patients with advanced cancer compared to using just haloperidol. Participants will be randomly assigned to receive either both drugs or only haloperidol alongside a placebo.See study design
What are the potential side effects?
Haloperidol may cause movement disorders or mood changes while Lorazepam could lead to drowsiness or memory problems. Both drugs might also contribute to an increased risk of falls due to muscle weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
Secondary outcome measures
Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min
Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lorazepam + HaloperidolExperimental Treatment3 Interventions
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
Group II: Placebo + HaloperidolActive Control3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Haloperidol
FDA approved
Questionnaires
2013
Completed Phase 2
~3330
Lorazepam
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,562 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,964,965 Total Patients Enrolled
David Hui, MDPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
101,447 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to haloperidol or benzodiazepines.I have taken benzodiazepine or chlorpromazine regularly in the last 48 hours.I have a close family member or partner involved.I have experienced severe confusion or agitation recently.I have been diagnosed with delirium.My heart failure is not getting worse right now.I am currently admitted to a unit specialized in severe symptom management.I can be at the patient's side for 4 hours daily during their confusion episodes.I have a history of myasthenia gravis or acute narrow angle glaucoma.I have had neuroleptic malignant syndrome in the past.I have been diagnosed with Parkinson's disease or dementia.I have taken 8 mg or less of haloperidol in the last day.My cancer is advanced and cannot be cured with surgery or radiation alone.I have seizures that are not controlled by medication.I am 18 years old or older.You have a history of long-lasting QT heart rhythm prolongation.I and my family caregiver can communicate in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Haloperidol
- Group 2: Lorazepam + Haloperidol
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.
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