Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Cancers
Intervention: Lorazepam (Drug); Placebo (Drug); Haloperidol decanoate (Drug); Questionnaires (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): David Hui, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Overall contact: David Hui, MD, Phone: 713-792-6085
Summary
The goal of this clinical research study is to learn if giving lorazepam in combination with
haloperidol can help to control the symptoms of delirium in patients with advanced cancer.
The safety of this drug combination will also be studied.
In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks
like the study drug but is not designed to treat any disease or illness. It is designed to
be compared with a study drug to learn if the study drug has any real effect.
Clinical Details
Official title: A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Control of Delirium Symptoms
Detailed description:
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive lorazepam.
- If you are in Group 2, you will receive a placebo.
Neither you nor the study staff will know if you are receiving the study drug or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving. You will have an equal chance of being in each group.
All patients will receive haloperidol as part of your standard of care. The study doctor
can tell you more about haloperidol, how it is designed to work, and about any side effects
it may have.
Study Drug Administration:
After you have started receiving haloperidol, you will receive lorazepam or the placebo by
vein 1 time over about 1-2 minutes.
Study Tests:
Every day while you are in the palliative care unit, you will be asked to complete the same
questionnaires about symptoms and how you are feeling that you were asked at screening. If
at any point you recover from your confusion, you will be asked if you remember the
confusion and how distressing it was.
Saliva Samples:
While you are in the hospital, saliva samples (about 1/2 a teaspoon) will be collected every
day to check for changes in your body's chemical levels. To collect the saliva, a swab will
be brushed inside your mouth until enough saliva is gathered on the swab. This should take
about 30 seconds to complete.
Length of Study:
You will receive the study drug or placebo 1 time. You will be monitored as part of this
study until you leave the palliative care unit. You may go off study at any time that
you/your caregiver decides it is in your best interest.
This is an investigational study. Lorazepam is FDA approved and commercially available for
the treatment of anxiety, insomnia, and seizures. Its use to help control
agitation/delirium is investigational.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. [Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic,
recurrent, or incurable disease)
2. [Patients] Admitted to Acute Palliative Care Unit (APCU)
3. [Patients] Delirium as per the Diagnostic and Statistical Manual of Mental Disorders
(DSM-IV-TR) criteria
4. [Patients] Hyperactive/mixed delirium with RASS >/=2 in the last 24 hours
5. [Patients] On scheduled haloperidol of =8 mg in the last 24 hours
6. [Patients] Age 18 or older
7. [Patients] Legally Authorized Representative consent
8. [Family Caregivers] Patient's spouse, adult child, sibling, parent, other relative,
or significant other (defined by the patient as a partner)
9. [Family Caregivers] Age 18 or older
10. [Family Caregivers] At the patient's bedside at least 4 hours each day during patient
delirium episode
11. [Family Caregivers] Able to communicate in English
Exclusion Criteria:
1. [Patients] History of myasthenia gravis or acute narrow angle glaucoma
2. [Patients] Hepatic encephalopathy at the time of screening
3. [Patients] History of neuroleptic malignant syndrome
4. [Patients] History of Parkinson's disease or dementia
5. [Patients] History of seizure disorder
6. [Patients] History of hypersensitivity to haloperidol or benzodiazepine
7. [Patients] On regular doses of benzodiazepine or chlorpromazine within the past 48
hours
8. [Patients] Previously documented and persistent QTc prolongation (>500 ms)
9. [Patients] Heart failure exacerbation at the time of enrollment
Locations and Contacts
David Hui, MD, Phone: 713-792-6085
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information
University of Texas MD Anderson Cancer Center
Starting date: January 2014
Last updated: August 5, 2015
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