Trial · NCT03021486
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
NCT03021486, Phase 2, Phase 3, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2022-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer. Trials, record NCT03021486. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03021486
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
- NCT number
- NCT03021486
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 70 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Advanced Malignant Neoplasm, Delirium, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Interventions
- Chlorpromazine, Haloperidol, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2017-01-16
- Last updated
- 2026-09-14
- Results first posted
- 2022-09-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Richmond Agitation Sedation Score (RASS) (0-24h) | Time 0 or Baseline and 24 hours after study medication administration | 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. |
| Secondary | Percentage of Participants With RASS Score -2 to 0 | Time 0 or Baseline and 24 hours later. | 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. |
| Secondary | Change in RASS Score (0-30 Minutes) | Time 0 or Baseline and 30 minutes later. | 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. |
| Secondary | Number of Participants With RASS Score of >=1 | 0 or Baseline and 24 hours later | 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. |
| Secondary | Pattern of Medication Use | Baseline and 24 hours | Use of neuroleptics and benzodiazepines during the first 24 hours was retrieved from the Medication Administration Record. |
| Secondary | Perceived Comfort Level as Assessed by Caregiver | Baseline and 24 hour | 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). |
| Secondary | Perceived Comfort Level as Assessed by Nurse | Baseline and 24 hour | 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). |
| Secondary | Change in Delirium Experience Questionnaire | Baseline and Day 3 | 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. |
| Secondary | Memorial Delirium Assessment Scale (MDAS) | Baseline and 24 hours | 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. |
| Secondary | Edmonton Expression Assessment System, ESAS | Baseline and 24 hours | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Richmond Agitation Sedation Score (RASS) (0-24h) | Time 0 or Baseline and 24 hours after study medication administration | Analysis included 31 participants who completed 24 hours of the study. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With RASS Score -2 to 0 | Time 0 or Baseline and 24 hours later. | Analysis included 31 participants who completed 24 hours of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in RASS Score (0-30 Minutes) | Time 0 or Baseline and 30 minutes later. | Analysis included 45 participants who completed first 30 minutes of study | score on a scale | MEAN |
| SECONDARY | Number of Participants With RASS Score of >=1 | 0 or Baseline and 24 hours later | Analysis included 45 participants who completed first 24 hours of study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pattern of Medication Use | Baseline and 24 hours | Analysis included 45 participants who were still on study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Perceived Comfort Level as Assessed by Caregiver | Baseline and 24 hour | Analysis included 37 participants who completed this questionnaire at that time point | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Perceived Comfort Level as Assessed by Nurse | Baseline and 24 hour | Analysis included 37 participants who completed this questionnaire at that time point | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Delirium Experience Questionnaire | Baseline and Day 3 | Analysis included 37 participants who completed this questionnaire at that time point. | score on a scale | MEAN |
| SECONDARY | Memorial Delirium Assessment Scale (MDAS) | Baseline and 24 hours | Analysis included 30 participants who completed this questionnaire at that time point | score on a scale | MEAN |
| SECONDARY | Edmonton Expression Assessment System, ESAS | Baseline and 24 hours | 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 | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Richmond Agitation Sedation Score (RASS) (0-24h) | Escalation Group | -3.6 | 95% Confidence Interval -5.0 to -2.2 | score on a scale | |
| Change in Richmond Agitation Sedation Score (RASS) (0-24h) | Rotation Group | -3.3 | 95% Confidence Interval -4.4 to -2.2 | score on a scale | |
| Change in Richmond Agitation Sedation Score (RASS) (0-24h) | Combination Group | -3.0 | 95% Confidence Interval -4.6 to -1.4 | score on a scale | |
| Percentage of Participants With RASS Score -2 to 0 | Escalation Group | 2 | Participants | ||
| Percentage of Participants With RASS Score -2 to 0 | Rotation Group | 3 | Participants | ||
| Percentage of Participants With RASS Score -2 to 0 | Combination Group | 5 | Participants | ||
| Change in RASS Score (0-30 Minutes) | Escalation Group | -2.6 | 95% Confidence Interval -3.6 to -1.6 | score on a scale | |
| Change in RASS Score (0-30 Minutes) | Rotation Group | -2.4 | 95% Confidence Interval -3.0 to -1.8 | score on a scale | |
| Change in RASS Score (0-30 Minutes) | Combination Group | -2.1 | 95% Confidence Interval -3.0 to -1.3 | score on a scale | |
| Number of Participants With RASS Score of >=1 | Escalation Group | 12 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Escalation Group | 23 | |
| Overall Study | STARTED | Rotation Group | 22 | |
| Overall Study | STARTED | Combination Group | 23 | |
| Overall Study | COMPLETED | Escalation Group | 15 | |
| Overall Study | COMPLETED | Rotation Group | 16 | |
| Overall Study | COMPLETED | Combination Group | 14 | |
| Overall Study | NOT COMPLETED | Escalation Group | 8 | |
| Overall Study | NOT COMPLETED | Rotation Group | 6 | |
| Overall Study | NOT COMPLETED | Combination Group | 9 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Akathisia | Nervous system disorders | Escalation Group (Haloperidol Dose Escalation Group) | 0 | 15 | |
| other | Akathisia | Nervous system disorders | Rotation Group | 0 | 16 | |
| other | Akathisia | Nervous system disorders | Combination Group | 1 | 14 | |
| other | Apnoea | Respiratory, thoracic and mediastinal disorders | Escalation Group (Haloperidol Dose Escalation Group) | 0 | 15 | |
| other | Apnoea | Respiratory, thoracic and mediastinal disorders | Rotation Group | 0 | 16 | |
| other | Apnoea | Respiratory, thoracic and mediastinal disorders | Combination Group | 1 | 14 | |
| other | Hypotension | Cardiac disorders | Escalation Group (Haloperidol Dose Escalation Group) | 6 | 15 | |
| other | Hypotension | Cardiac disorders | Rotation Group | 5 | 16 | |
| other | Hypotension | Cardiac disorders | Combination Group | 3 | 14 | |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Escalation Group (Haloperidol Dose Escalation Group) | 2 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Escalation Group (Haloperidol Dose Escalation Group) | 14 | 15 |
| Total, all-cause mortality | Rotation Group | 16 | 16 |
| Total, all-cause mortality | Combination Group | 14 | 14 |
| Total, other adverse events | Escalation Group (Haloperidol Dose Escalation Group) | 6 | 15 |
| Total, other adverse events | Rotation Group | 5 | 16 |
| Total, other adverse events | Combination Group | 3 | 14 |
| Total, serious adverse events | Escalation Group (Haloperidol Dose Escalation Group) | 0 | 15 |
| Total, serious adverse events | Rotation Group | 0 | 16 |
| Total, serious adverse events | Combination Group | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32479786 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| R21NR016736 | Palliative Therapies for Refractory Delirium in Advanced Cancer | HUI, DAVID | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL INSTITUTE OF NURSING RESEARCH | 2017 to 2018 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03021486
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