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Advanced Cancers | Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

Advanced Cancers research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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. [Patients and Family Caregivers] Able to communicate in English or Spanish Exclusion Criteria: 1. [Patients] History of myasthenia gravis or acute narrow angle glaucoma 2. [Patients] History of neuroleptic malignant syndrome 3. [Patients] History of Parkinson's disease or dementia 4. [Patients] Uncontrolled seizure disorder 5. [Patients] History of hypersensitivity to haloperidol or benzodiazepine 6. [Patients] On regular doses of benzodiazepine or chlorpromazine within the past 48 hours 7. [Patients] Previously documented and persistent QTc prolongation (>500 ms) 8. [Patients] Heart failure exacerbation at the time of enrollment

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Advanced Cancers

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Lorazepam3 mg by vein one time only.

Drug:PlaceboPlacebo consisting of preservative free 0.9% normal saline given one time by vein.

Drug:Haloperidol decanoate8 mg/day by vein.

Behavioral:QuestionnairesQuestionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Lorazepam + HaloperidolParticipants 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

Placebo + HaloperidolParticipants 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

Study Status

Active, not recruiting

Start Date: January 2014

Completed Date: January 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Control of Delirium Symptoms

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: David Hui, MD

Lead Sponsor: M.D. Anderson Cancer Center

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01949662

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