Trial Outcomes & Findings for Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer (NCT NCT03021486)

Last Updated: 2025-09-08

Results Overview

RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was mean change in RASS score between time 0 (immediately before initiation of masked treatment) and 24 h later. The Richmond Agitation-Sedation Scale (RASS) was developed by a multidisciplinary team at Virginia Commonwealth University in Richmond; it is a validated method used to avoid oversedation in the Intensive Care Unit.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

70 participants

Primary outcome timeframe

Time 0 or Baseline and 24 hours after study medication administration

Results posted on

2025-09-08

Participant Flow

Adult participants (age\>18) with an active diagnosis of cancer were recruited between palliative and supportive Care unit at MD Anderson Cancer Center who met the inclusion and exclusion criteria.

A total of 70 participants were consented, 2 were inevaluable and 68 were randomly assigned for interventions.

Participant milestones

Participant milestones
Measure	Escalation Group Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Overall Study STARTED	23	22	23
Overall Study COMPLETED	15	16	14
Overall Study NOT COMPLETED	8	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Escalation Group Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Overall Study Withdrawal by Subject	1	1	3
Overall Study Did not develop an RASS score of at least >= 1	7	5	6

Baseline Characteristics

Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escalation Group n=15 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=16 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=14 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Total n=45 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	63 years n=7 Participants	60 years n=5 Participants	64 years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	41 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	14 participants n=5 Participants	45 participants n=4 Participants
Education Some High school or less	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Education Completed High School	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Education Some College	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Education College	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Education Advanced degree	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Cancer Type Breast	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Cancer Type Genitourinary	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Cancer Type Gastrointestinal	5 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 Participants
Cancer Type Gynecological	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Cancer Type Hematological	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Cancer Type Respiratory	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Cancer Type Others	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Metastatic cancer or advanced stage disease	15 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants

PRIMARY outcome

Timeframe: Time 0 or Baseline and 24 hours after study medication administration

Population: Analysis included 31 participants who completed 24 hours of the study.

Outcome measures

Outcome measures
Measure	Escalation Group n=10 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=11 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=10 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Change in Richmond Agitation Sedation Score (RASS) (0-24h)	-3.6 score on a scale Interval -5.0 to -2.2	-3.3 score on a scale Interval -4.4 to -2.2	-3.0 score on a scale Interval -4.6 to -1.4

SECONDARY outcome

Timeframe: Time 0 or Baseline and 24 hours later.

Population: Analysis included 31 participants who completed 24 hours of the study.

RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The Secondary outcome was the percentage of participants with target RASS score of -2 to 0 within the first 24 hours. The Richmond Agitation-Sedation Scale (RASS) was developed by a multidisciplinary team at Virginia Commonwealth University in Richmond; it is a validated method used to avoid over sedation in the Intensive Care Unit.

Outcome measures

Outcome measures
Measure	Escalation Group n=10 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=11 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=10 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Percentage of Participants With RASS Score -2 to 0	2 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Time 0 or Baseline and 30 minutes later.

Population: Analysis included 45 participants who completed first 30 minutes of study

RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The secondary outcome was mean change in RASS score between time 0 (immediately before initiation of masked treatment) and 30 minutes later. The Richmond Agitation-Sedation Scale (RASS) was developed by a multidisciplinary team at Virginia Commonwealth University in Richmond; it is a validated method used to avoid over sedation in the Intensive Care Unit.

Outcome measures

Outcome measures
Measure	Escalation Group n=15 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=16 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=14 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Change in RASS Score (0-30 Minutes)	-2.6 score on a scale Interval -3.6 to -1.6	-2.4 score on a scale Interval -3.0 to -1.8	-2.1 score on a scale Interval -3.0 to -1.3

SECONDARY outcome

Timeframe: 0 or Baseline and 24 hours later

Population: Analysis included 45 participants who completed first 24 hours of study

RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The secondary outcome was the proportion of breakthrough restlessness participants with a RASS score of \>=1 during the first 24 hours. The Richmond Agitation-Sedation Scale (RASS) was developed by a multidisciplinary team at Virginia Commonwealth University in Richmond; it is a validated method used to avoid oversedation in the Intensive Care Unit.

Outcome measures

Outcome measures
Measure	Escalation Group n=15 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=16 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=14 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Number of Participants With RASS Score of >=1	12 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and 24 hours

Population: Analysis included 45 participants who were still on study.

Use of neuroleptics and benzodiazepines during the first 24 hours was retrieved from the Medication Administration Record.

Outcome measures

Outcome measures
Measure	Escalation Group n=15 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=16 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=14 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Pattern of Medication Use Need for study med dose escalation in first 24 hrs	4 Participants	1 Participants	7 Participants
Pattern of Medication Use Benzodiazepine use in first 24 hrs (scheduled)	1 Participants	0 Participants	0 Participants
Pattern of Medication Use Benzodiazepine use in first 24 hrs (as needed)	0 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and 24 hour

Population: Analysis included 37 participants who completed this questionnaire at that time point

On day 1 (after initiation of blinded treatment), we asked the blinded caregivers to provide their overall impression of change in patient comfort level and the agitation level. The response ranged from "strongly agree", "agree", "neutral", "disagree", and "strongly disagree". In this study, "strongly agree" and "agree" were combined for analysis. The participants who reported 'Agree' and 'Strongly Agree' responses to perceived comfort level have a high level of comfort (more comfortable). And similarly, the participants who reported 'Agree' and 'Strongly Agree' responses to perceived agitation level have a low level of agitation (less agitated).

Outcome measures

Outcome measures
Measure	Escalation Group n=13 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=14 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=10 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Perceived Comfort Level as Assessed by Caregiver Perceived To Have A Low Level of Agitation (Less Agitated)	9 Participants	10 Participants	6 Participants
Perceived Comfort Level as Assessed by Caregiver Perceived To Have A High Level of Comfort (More Comfortable)	8 Participants	10 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and 24 hour

Population: Analysis included 37 participants who completed this questionnaire at that time point

Outcome measures

Outcome measures
Measure	Escalation Group n=14 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=12 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=11 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Perceived Comfort Level as Assessed by Nurse Perceived To Have A High Level of Comfort (More Comfortable)	9 Participants	9 Participants	7 Participants
Perceived Comfort Level as Assessed by Nurse Perceived To Have A Low Level of Agitation (Less Agitated)	8 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline and Day 3

Population: Analysis included 37 participants who completed this questionnaire at that time point.

This 14-item questionnaire examines both the recalled frequency of 7 delirium symptoms and associated distress in the rater: disorientation to time, disorientation to place, visual hallucinations, tactile hallucinations, auditory hallucinations, delusional thoughts and psychomotor agitation. The score for recalled frequency ranges between 0 and 4, where 0=not present, 1=a little of the time, 2=some of the time, 3=good part of the time, and 4=most or all of the time. The score for distress in the rater related to each delirium symptom also ranges from 0 to 4, where 0=no distress, 1=a little, 2=a fair amount, 3=very much and 4=extremely distressed. Due to an error in the data collection form, the last category was omitted as a choice and thus the score only ranged from 0 to 3.

Outcome measures

Outcome measures
Measure	Escalation Group n=14 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=12 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=11 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Change in Delirium Experience Questionnaire Nursing assessment, disorientation to place - frequency	-0.9 score on a scale Interval -1.7 to -0.1	-0.8 score on a scale Interval -1.7 to 0.2	0.3 score on a scale Interval -0.7 to 1.3
Change in Delirium Experience Questionnaire Nursing assessment, visual hallucination - frequency	-1 score on a scale Interval -1.6 to -0.5	0 score on a scale Interval -0.6 to 0.6	-0.7 score on a scale Interval -1.5 to 0.0
Change in Delirium Experience Questionnaire Nursing assessment, disorientation to time - frequency	-0.8 score on a scale Interval -1.7 to 0.1	-0.8 score on a scale Interval -1.6 to 0.1	0.2 score on a scale Interval -0.8 to 1.1
Change in Delirium Experience Questionnaire Nursing assessment, tactile hallucination - frequency	-0.4 score on a scale Interval -1.1 to 0.3	0.1 score on a scale Interval -0.1 to 0.3	-0.9 score on a scale Interval -1.7 to -0.2
Change in Delirium Experience Questionnaire Nursing assessment, auditory hallucination - frequency	-0.1 score on a scale Interval -0.5 to 0.2	0.1 score on a scale Interval -0.1 to 0.3	-0.4 score on a scale Interval -0.8 to 0.1
Change in Delirium Experience Questionnaire Nursing assessment, delusional thoughts - frequency	-0.8 score on a scale Interval -1.5 to 0.0	0 score on a scale Interval -0.3 to 0.3	0.2 score on a scale Interval -0.5 to 0.9
Change in Delirium Experience Questionnaire Nursing assessment, psychomotor agitation- frequency	-1.2 score on a scale Interval -1.9 to -0.5	-0.8 score on a scale Interval -1.7 to 0.0	-0.4 score on a scale Interval -1.0 to 0.3
Change in Delirium Experience Questionnaire Nursing assessment, disorientation to time - distress	-0.3 score on a scale Interval -0.6 to 0.1	-0.3 score on a scale Interval -0.7 to 0.2	-0.5 score on a scale Interval -1.2 to 0.2
Change in Delirium Experience Questionnaire Nursing assessment, disorientation to place - distress	-0.3 score on a scale Interval -0.6 to 0.1	-0.3 score on a scale Interval -0.7 to 0.2	-0.4 score on a scale Interval -1.1 to 0.4
Change in Delirium Experience Questionnaire Nursing assessment, visual hallucination - distress	-0.6 score on a scale Interval -1.3 to 0.0	0.1 score on a scale Interval -0.1 to 0.3	-0.4 score on a scale Interval -0.9 to 0.2
Change in Delirium Experience Questionnaire Nursing assessment, tactile hallucination - distress	-0.5 score on a scale Interval -1.1 to 0.1	0 score on a scale Interval 0.0 to 0.0	-0.5 score on a scale Interval -1.1 to 0.2
Change in Delirium Experience Questionnaire Nursing assessment, auditory hallucination - distress	-0.3 score on a scale Interval -0.9 to 0.3	0 score on a scale Interval 0.0 to 0.0	-0.2 score on a scale Interval -0.6 to 0.2
Change in Delirium Experience Questionnaire Nursing assessment, delusional thoughts - distress	-0.6 score on a scale Interval -1.4 to 0.1	0 score on a scale Interval 0.0 to 0.0	-0.1 score on a scale Interval -0.6 to 0.4
Change in Delirium Experience Questionnaire Nursing assessment, psychomotor agitation - distress	-0.8 score on a scale Interval -1.4 to -0.2	-0.5 score on a scale Interval -0.9 to -0.1	-0.8 score on a scale Interval -1.5 to -0.1

SECONDARY outcome

Timeframe: Baseline and 24 hours

Population: Analysis included 30 participants who completed this questionnaire at that time point

The Memorial Delirium Assessment Scale (MDAS) is a 10-item clinician-rated assessment scale validated for assessment of delirium in cancer patients. It examines the level of consciousness, disorientation, memory, recall, attention, disorganized thinking, perceptual disturbance, delusions, psychomotor activity and sleep, assigning a score between 0 to 3, for a total score between 0-30. A total score of 13 or higher indicates delirium. We measured the change in Memorial Delirium Rating scale between baseline and 24 hours.

Outcome measures

Outcome measures
Measure	Escalation Group n=9 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=11 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=10 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Memorial Delirium Assessment Scale (MDAS)	-2.7 score on a scale Interval -6.0 to 0.7	1 score on a scale Interval -0.3 to 2.3	0.3 score on a scale Interval -2.9 to 3.5

SECONDARY outcome

Timeframe: Baseline and 24 hours

Population: Analysis included 33 participants who completed this questionnaire at that time point. Note that 9 participants completed 'feeling of well being' question for Combination group, and 13 participants completed 'pain' and 'sleep' questions for Escalation group

Edmonton Symptom Assessment System (ESAS) has been validated and widely used in different clinical settings, including the acute palliative care unit. It assessed the average symptom intensity of 10 symptoms over the past 24 hours. Each symptom was assessed using an 11-point numeric rating scale, ranging from 0 (none) to 10 (worst). It was measured as change in ESAS as Perceived by Caregivers between baseline and day 1, mean.

Outcome measures

Outcome measures
Measure	Escalation Group n=13 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=11 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=10 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Edmonton Expression Assessment System, ESAS Pain	-1.3 score on a scale Interval -3.1 to 0.5	-4.1 score on a scale Interval -5.8 to -2.4	-1.1 score on a scale Interval -2.3 to 0.1
Edmonton Expression Assessment System, ESAS Fatigue	-0.5 score on a scale Interval -2.6 to 1.6	-3 score on a scale Interval -5.9 to -0.1	1 score on a scale Interval -0.8 to 2.8
Edmonton Expression Assessment System, ESAS Nausea	0.1 score on a scale Interval -0.3 to 0.5	-1.8 score on a scale Interval -3.1 to -0.5	-0.4 score on a scale Interval -1.1 to 0.3
Edmonton Expression Assessment System, ESAS Depression	-1.4 score on a scale Interval -3.2 to 0.4	-1.2 score on a scale Interval -3.6 to 1.2	-0.8 score on a scale Interval -2.3 to 0.7
Edmonton Expression Assessment System, ESAS Anxiety	-1.5 score on a scale Interval -3.7 to 0.7	-4.8 score on a scale Interval -6.6 to -3.1	-0.9 score on a scale Interval -3.4 to 1.6
Edmonton Expression Assessment System, ESAS Drowsiness	-0.2 score on a scale Interval -1.9 to 1.6	-0.6 score on a scale Interval -2.2 to 1.1	0.7 score on a scale Interval -1.8 to 3.2
Edmonton Expression Assessment System, ESAS Appetite	-0.3 score on a scale Interval -2.0 to 6.2	-0.6 score on a scale Interval -4.0 to 2.9	0.1 score on a scale Interval -2.3 to 2.5
Edmonton Expression Assessment System, ESAS Feeling of well being*	0.2 score on a scale Interval -2.0 to 2.3	-1.6 score on a scale Interval -4.7 to 1.6	0 score on a scale Interval -2.7 to 2.7
Edmonton Expression Assessment System, ESAS Shortness of breath	0.8 score on a scale Interval 0.0 to 1.6	-2.2 score on a scale Interval -5.0 to 0.6	0 score on a scale Interval -1.7 to 1.7
Edmonton Expression Assessment System, ESAS Sleep	-2.7 score on a scale Interval -4.7 to -0.7	-5.1 score on a scale Interval -7.3 to -2.9	-2.7 score on a scale Interval -4.5 to -0.9

SECONDARY outcome

Timeframe: Baseline and 3 days

Population: Analysis included 25 participants who were still on study

We also documented the selected adverse effects associated with neuroleptics using the Udvalg for Kliniske Undersogelser (UKU) side effects rating scale. Specifically, we assessed 8 neurologic symptoms (dystonia, rigidity, hypokinesia/akinesia, hyperkinesia, tremor, akathisia, epileptic seizures, paraesthesias). We are reporting only the neurologic symptoms (tremor and akathisia) that had changes during the study. Each item was assigned a score by the research coordinator 0 (absent) to 3 (most severe) based on symptom severity of the last 3 days.

Outcome measures

Outcome measures
Measure	Escalation Group n=7 Participants Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=9 Participants Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=9 Participants Participants receive 1 mg of haloperidol and 12.5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Udvalg for Kliniske Undersogelser, UKU Tremor (decreased)	0 Participants	0 Participants	1 Participants
Udvalg for Kliniske Undersogelser, UKU Akathisia (decreased)	0 Participants	0 Participants	1 Participants

Adverse Events

Escalation Group (Haloperidol Dose Escalation Group)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 14 deaths

Rotation Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 16 deaths

Combination Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 14 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Escalation Group (Haloperidol Dose Escalation Group) n=15 participants at risk Participants receive 2 mg of haloperidol IV over 3-15 minutes every 4 hours in absence of unacceptable toxicity.	Rotation Group n=16 participants at risk Participants receive 25 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.	Combination Group n=14 participants at risk Participants receive 1 mg of haloperidol and 12·5 mg of chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Nervous system disorders Akathisia	0.00% 0/15 • Baseline and 24 hr.	0.00% 0/16 • Baseline and 24 hr.	7.1% 1/14 • Baseline and 24 hr.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/15 • Baseline and 24 hr.	0.00% 0/16 • Baseline and 24 hr.	7.1% 1/14 • Baseline and 24 hr.
Cardiac disorders Hypotension	40.0% 6/15 • Baseline and 24 hr.	31.2% 5/16 • Baseline and 24 hr.	21.4% 3/14 • Baseline and 24 hr.
Respiratory, thoracic and mediastinal disorders Hypoxia	13.3% 2/15 • Baseline and 24 hr.	0.00% 0/16 • Baseline and 24 hr.	0.00% 0/14 • Baseline and 24 hr.
Cardiac disorders Sinus Tachycardia	0.00% 0/15 • Baseline and 24 hr.	6.2% 1/16 • Baseline and 24 hr.	14.3% 2/14 • Baseline and 24 hr.

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