Overview

This trial is active, not recruiting.

Condition advanced cancers
Treatments lorazepam, placebo, haloperidol decanoate, questionnaires
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 2014
End date January 2018
Trial size 93 participants
Trial identifier NCT01949662, 1R21CA186000-01A1, 2013-0345, NCI-2013-02351

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
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
lorazepam
3 mg by vein one time only.
haloperidol decanoate
8 mg/day by vein.
questionnaires Surveys
Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.
(Active Comparator)
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
placebo
Placebo consisting of preservative free 0.9% normal saline given one time by vein.
haloperidol decanoate
8 mg/day by vein.
questionnaires Surveys
Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.

Primary Outcomes

Measure
Control of Delirium Symptoms
time frame: 8 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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 500 ms) 8. [Patients] Heart failure exacerbation at the time of enrollment

Additional Information

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
Principal investigator David Hui, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in September 2016.