Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Substance Related Disorders

Rare Diseases

Syndrome

Delirium

Neurotoxicity Syndromes

Confusion

Neurobehavioral Manifestations

Neurologic Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Acute Graft Versus Host Disease

Anticonvulsants

Antiemetics

Central Nervous System Depressants

Psychotropic Drugs

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Dyskinesia Agents

Cardiotonic Agents

Lorazepam

Haloperidol

Haloperidol decanoate

Antipsychotic Agents

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Hypnotics and Sedatives

Anti-Anxiety Agents

GABA Modulators

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

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

Placebo

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

Questionnaires

David Hui, MD

This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.

PRIMARY OBJECTIVES:

I. To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on the intensity of agitation (Richmond Agitation Sedation Scale) over 8 hours.

II. To assess the within-arm effect of single-dose lorazepam or placebo, as an adjuvant agent with haloperidol, on agitation intensity (Richmond Agitation Sedation Scale) over 8 hours in patients admitted to an acute palliative care unit.

SECONDARY OBJECTIVES:

I. To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on (1) delirium related distress in nurses and caregivers, (2) delirium duration, (3) need for rescue doses of neuroleptics, (4) delirium recall, (5) symptom expression (Edmonton Symptom Assessment Scale), (6) communicative capacity, (7) adverse effects, (8) discharge outcomes, and (9) survival in cancer patients.

II. To evaluate proportion of patients who consent and are randomized to study however drop out before being treated or before finishing 8-hour Richmond Agitation Sedation Scale (RASS) assessment; and the reasons of drop-outs will be documented and reported.

III. To explore the changes in biomarker levels in saliva samples (salivary cortisol, cholinesterase, C-reactive protein, interleukin-1 beta, -6, and -10) over time and in association with delirium severity.

IV. To examine the inter-rater reliability of RASS in the Acute Palliative Care Unit (APCU) setting between the bedside nurse and the research nurse at the time of study enrollment.

V. To conduct exploratory analyses on RASS as an outcome. VI. To examine the association among rescue medication use, RASS and perceived comfort by the nurses and caregivers.

VII. To examine the proportion of patients enrolled onto the delirium trial who achieved control of agitation and did not require the randomized study medication.

VIII. To identify patient factors associated with control of agitated delirium.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lorazepam intravenously (IV) over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

ARM II: Patients receive placebo IV over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit

The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

Change in Richmond Agitation-Sedation Scale score from baseline to 30 min. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

Number of participants with Richmond Agitation-Sedation Scale score \>=1 within 8 hr. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

UKU (Udvalg for Kliniske Undersøgelser ) Adverse events Assessment. Total intent to treat = 58 (29+29); Total Participants used for the All Cause Mortality in both Arms, Intervention (47), and Placebo (43). The total number of deaths in the Intervention Group were 10 which includes 9 from the incomplete category and 1 from the complete category. The total number of deaths in the Control Group were 10 which includes 7 from the incomplete category and 3 from the complete category.

Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)

Intervention Group (Lorazepam & Haloperidol)

Received single dose of Haloperidol (2mg IV, once)

Control Group (Placebo & Haloperidol)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

High School or less

College

Completed College

Not Available

Education

Metastatic Cancer

Locally advanced

Recurrent or Persistent

Cancer Stage

GastroIntestinal Cancer

Hematological Cancer

Genitourinary

Head and neck

Breast

Respiratory Cancer

Gynecological

Other

Cancer Type

The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities.

Karnofsky performance status

Intent to treat analysis of 58 participants, 29 for each arm

David Hui, MD/ Associate Professor, Palliative Care Medicine

Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm.

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points

Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points

Intent to treat 58 participants, a total of 29 for each arm

Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min

Intent to treat 58 participants, a total of 29 from each arm

Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer	NCT01949662	Advanced Cancer...	Lorazepam Placebo Haloperidol dec... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer	NCT01949662	Advanced Cancer...	Lorazepam Placebo Haloperidol dec... Questionnaires	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for haloperidol decanoate