Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

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

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.

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.

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 500 ms) 9. [Patients] Heart failure exacerbation at the time of enrollment

David Hui, MD, Phone: 713-792-6085

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting

University of Texas MD Anderson Cancer Center

Starting date: January 2014
Last updated: August 5, 2015