Trial Outcomes & Findings for Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer (NCT NCT01949662)
NCT ID: NCT01949662
Last Updated: 2025-07-31
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Baseline to 8 hours
Results posted on
2025-07-31
Participant Flow
Patients were recruited between 1/2014 and 6/2016 from MD Anderson Cancer Center with active cancer diagnosis, having age \>=18, with Delirium with Richmond Agitation-Sedation Scale score of \>=2 and receiving scheduled Haloperidol 1-8 mg/day.
3 patients were excluded before randomization. 1 died and 2 were ineligible.
Participant milestones
| Measure |
Intervention Group (Lorazepam & Haloperidol)
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
43
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
Reasons for withdrawal
| Measure |
Intervention Group (Lorazepam & Haloperidol)
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Overall Study
Death
|
9
|
7
|
|
Overall Study
Discharged before an agitation event
|
8
|
3
|
|
Overall Study
Dropped out
|
1
|
3
|
|
Overall Study
Ineligible
|
0
|
1
|
Baseline Characteristics
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Intervention Group (Lorazepam & Haloperidol)
n=29 Participants
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
n=29 Participants
Received single dose of Haloperidol (2mg IV, once)
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 Years
n=5 Participants
|
64 Years
n=7 Participants
|
65 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Education
High School or less
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education
College
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
Completed College
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education
Not Available
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Stage
Metastatic Cancer
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Cancer Stage
Locally advanced
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Stage
Recurrent or Persistent
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cancer Type
GastroIntestinal Cancer
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cancer Type
Hematological Cancer
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cancer Type
Genitourinary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cancer Type
Head and neck
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Type
Respiratory Cancer
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Cancer Type
Gynecological
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cancer Type
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Karnofsky performance status
10%
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Karnofsky performance status
20%
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Karnofsky performance status
30%
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Karnofsky performance status
40%
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 hoursPopulation: Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm.
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.
Outcome measures
| Measure |
Intervention Group (Lorazepam & Haloperidol)
n=26 Participants
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
n=26 Participants
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
|
-4.1 score on a scale
Interval -4.8 to -3.4
|
-2.3 score on a scale
Interval -2.9 to -1.6
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm.
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.
Outcome measures
| Measure |
Intervention Group (Lorazepam & Haloperidol)
n=26 Participants
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
n=26 Participants
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
|
-2.5 score on a scale
Interval -3.2 to -1.9
|
-0.7 score on a scale
Interval -1.3 to -0.1
|
SECONDARY outcome
Timeframe: Baseline to 30 minutesPopulation: Intent to treat 58 participants, a total of 29 for each arm
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.
Outcome measures
| Measure |
Intervention Group (Lorazepam & Haloperidol)
n=29 Participants
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
n=29 Participants
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min
|
-3.6 score on a scale
Interval -4.3 to -2.9
|
-1.6 score on a scale
Interval -2.2 to -1.0
|
SECONDARY outcome
Timeframe: Baseline to 8 hoursPopulation: 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. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Outcome measures
| Measure |
Intervention Group (Lorazepam & Haloperidol)
n=29 Participants
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
n=29 Participants
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr
|
8 Participants
|
22 Participants
|
Adverse Events
Intervention Group (Lorazepam & Haloperidol)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 10 deaths
Control Group (Placebo & Haloperidol)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (Lorazepam & Haloperidol)
n=29 participants at risk
Received single dose of Lorazepam (3 mg IV, once) and Haloperidol (2mg IV, once)
|
Control Group (Placebo & Haloperidol)
n=29 participants at risk
Received single dose of Haloperidol (2mg IV, once)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hypokinesia
|
10.3%
3/29 • Baseline up to 3 days
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.
|
13.8%
4/29 • Baseline up to 3 days
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.
|
|
Musculoskeletal and connective tissue disorders
Hyperkinesia
|
3.4%
1/29 • Baseline up to 3 days
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.
|
6.9%
2/29 • Baseline up to 3 days
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.
|
|
Musculoskeletal and connective tissue disorders
Akathisia
|
10.3%
3/29 • Baseline up to 3 days
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.
|
3.4%
1/29 • Baseline up to 3 days
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.
|
Additional Information
David Hui, MD/ Associate Professor, Palliative Care Medicine
UT MD Anderson Cancer Center
Phone: 713-792-6258
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place