Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT01949662 |
Other study ID # |
2013-0345 |
Secondary ID |
NCI-2013-023511R |
Status |
Active, not recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
January 2014 |
Est. completion date |
January 1, 2026 |
Study information
Verified date |
February 2024 |
Source |
M.D. Anderson Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.