DeliriumPhase 2/3NCT03743649
Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care
A Phase 2/3 study testing Haloperidol, Lorazepam and Quality-of-Life Assessment in people with Delirium and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
Trial summary
This phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
- What is being tested?
- Haloperidol, Lorazepam and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Jul 2019to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
- [Patients] Admitted to the acute palliative care unit‡
- [Patients] Delirium as per DSM-5 criteria
- [Patients] Hyperactive or mixed delirium with RASS ≥1* in the past 24 h despite efforts to treat potential underlying causes
- [Patients] On scheduled haloperidol for delirium (≤8 mg in the past 24 h) or required ≥4 mg of rescue haloperidol for agitation in the past 24 h
- [Patients] Age 18 years or older
- [Caregivers] Patient's spouse, adult child, sibling, parent, other relative, or significant other (partner as defined by patient)
- [Caregivers] Age 18 years or older
Who cannot join
- [Patients] History of myasthenia gravis or acute narrow angle glaucoma
- [Patients] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
- [Patients] History of Parkinson's disease, Alzheimer's or Lewy body dementia
- [Patients] History of prolonged QTc or QTcF interval (>500 ms)† if documented by most recent ECG within the past month
- [Patients] History of hypersensitivity to haloperidol or lorazepam
- [Patients] On scheduled lorazepam within the past 48 h
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
M D Anderson Cancer Center
Houston, Texas, 77030
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Strategies for Persistent Agitated Delirium in Palliative Care
This phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.
Read the detailed description
Primary Objectives:
- To compare the effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on the change in the Richmond Agitation Sedation Scale (RASS) score over 24 hours in patients admitted to an acute palliative care unit (APCU) who do not respond to low-dose haloperidol
Secondary Objectives:
- To compare the effects of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on (1) rescue medication use; (2) the proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of ≥ 1.5 points); (3) perceived comfort as assessed by caregivers and bedside nurses; (4) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire); (5) achievement of the proxy comfort goal; (6) symptom expression (Edmonton Symptom Assessment Scale [ESAS]); (7) delirium severity (Memorial Delirium Assessment Scale [MDAS]); (8) adverse effects; and (9) quality of end-of-life care.
II. To identify novel predictive markers of response to haloperidol and lorazepam.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP I: Patients receive haloperidol intravenously (IV) over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP II: Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP III: Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP IV: Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
- Conditions
- Delirium, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Being tested
- Haloperidol, Lorazepam, Placebo, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Delirium, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol, McN-JR-1625, R 1625, R-1625
Given IV
LorazepamDrug
Also called Ativan
Given IV
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (haloperidol, placebo) | Experimental | Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit. Receives: Drug: Haloperidol; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (lorazepam, placebo) | Experimental | Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit. Receives: Drug: Lorazepam; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group III (haloperidol, lorazepam) | Experimental | Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit. Receives: Drug: Haloperidol; Drug: Lorazepam; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group IV (placebo, lorazepam) | Experimental | Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit. Receives: Drug: Lorazepam; Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU)
The effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal will be compared on the change in the RASS score over 24 hours in patients admitted to an APCU who do not respond to low-dose haloperidol.(RASS between -2 and 0) Will use 2-sided t-tests for four pre-specified paired comparisons, if the required assumptions for this model are met. Non-parametric methods such as Wilcoxon rank-sum test may be used if any assumptions are violated.
Measured: Baseline to 24 hours
Secondary outcomes (10)
Rescue medication use
Will conduct Bonferroni adjustment for the number of rescue doses. Will perform a comparison among the four arms using analysis of variance (ANOVA), followed by selected pairwise t-test comparisons, or the Kruskal-Wallis test followed by pairwise Wilcoxon rank-sum tests if the data violate assumptions for ANOVA. Will also compare these outcomes longitudinally using linear mixed models, with treatment as a between-patient factor and time as a within-subject factor. Appropriate transformations will be used as needed to satisfy model assumptions.
Measured: At 24 hours
Proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of >= 1.5 points)
Will compare the proportions across all four treatment groups using a chi-squared test, followed by selected pairwise chi-squared tests. We will also compare these outcomes longitudinally and include all data after treatment administration using generalized linear mixed models, with treatment as a between-patient factor and time as a within-subject factor.
Measured: At 24 hours
Perceived comfort as assessed by caregivers and bedside nurses questionnaire
Will be used for patients with caregivers or nurses listing "agree" or "strongly agree" for patient comfort, proportion of patients with at least 2 on the Udvalg for Kliniske Undersogelser (UKU) scale, and proportion of patients with caregivers listing "excellent" quality of end-of-life care)
Measured: At 24 hours
Delirium-related distress in caregivers and nurses assessed using Delirium Experience Questionnaire
Examines both the recalled frequency of 6 delirium symptoms and associated distress in the rater: disorientation to time and place, visual/tactile/auditory hallucinations, delusional thoughts, and psychomotor agitation. It will be administered to family caregivers and nurses daily. 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. This assessment will be administered to the blinded caregivers and bedside nurses daily.
Measured: At 24 hours
Proxy comfort goal level
The achievement of the proxy comfort goal will be assessed.
Measured: Up to 24 hours
Symptom expression assessed using Edmonton Symptom Assessment Scale
Validated and widely used in different clinical settings, including the APCU. It assesses the average symptom intensity of 10 symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep, and feeling of well-being) over the past 24 hours using an 11-point numeric rating scale, ranging from 0 (none) to 10 (worst). Because all patients will be delirious, caregivers will be asked to provide their proxy rating of ESAS daily.
Measured: At 24 hours
Delirium severity assessed using Memorial Delirium Assessment Scale
Will perform a comparison among the four arms using ANOVA, followed by selected pairwise t-test comparisons, or the Kruskal-Wallis test followed by pairwise Wilcoxon rank-sum tests if the data violate assumptions for ANOVA. Will also compare these outcomes longitudinally using linear mixed models, with treatment as a between-patient factor and time as a within-subject factor. Appropriate transformations will be used as needed to satisfy model assumptions.
Measured: At 24 hours
Incidence of adverse events
Measured: Up to 24 hours
Quality of end-of-life care: questionnaire
Will phone the bereaved caregivers who were most involved in the patient's care within 4-8 weeks of the patient's death to assess the patient's perceived quality of care and quality of life at the end-of-life, on the basis of questions previously used in the Coping with Cancer Study. Specifically, will ask caregivers, "Overall, how would you rate the care (the patient) received at the palliative care unit? Would you say it was excellent, very good, good, fair, or poor?" and "In your opinion, how would you rate the overall quality of (the patient)'s death or last week of life?" using a numeric rating scale from 0 (worst possible) to 10 (best possible). Will also ask them 2 questions related to control of agitation, adapted from the Quality of Death and Dying Questionnaire.
Measured: 4-8 weeks
To identify novel predictive markers of response to haloperidol and lorazepam.
In each of the groups, will identify independent factors that are predictive of response (i.e. RASS reduction of >= 1.5 points) to treatment using multivariable logistic regression analysis. Will assess the predictive value of plasma biomarkers (i.e. IL-6, IL-8, IL-10, and S100B) in the subset of patients.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start17 Jul 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Hui, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743649
- Sponsor's protocol ID
- 2018-0706
- Other IDs
- NCI-2018-02438, 2018-0706
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2018
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hui D, De La Rosa A, Tsai JS, Cheng SY, Del Fabbro E, Thomas Kuzhiyil AT, Rowe K, Azhar A, Nguyen T, Tang M, Yao CA, Huang HL, Peng JK, Hu WY, Admane S, Dev R, Chen M, Bramati P, Shete S, Bruera E. Proportional Sedation for Persistent Agitated Delirium in Palliative Care: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1031-1043. doi: 10.1001/jamaoncol.2025.2212.
PubMed 40742738
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Persistent Agitated Delirium in Palliative Care
- ClinicalTrials.gov ID
- NCT03743649
- Acronym / sponsor ID
- 2018-0706
- Conditions
- Delirium, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.
Detailed description
Primary Objectives:
- To compare the effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on the change in the Richmond Agitation Sedation Scale (RASS) score over 24 hours in patients admitted to an acute palliative care unit (APCU) who do not respond to low-dose haloperidol
Secondary Objectives:
- To compare the effects of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on (1) rescue medication use; (2) the proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of ≥ 1.5 points); (3) perceived comfort as assessed by caregivers and bedside nurses; (4) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire); (5) achievement of the proxy comfort goal; (6) symptom expression (Edmonton Symptom Assessment Scale [ESAS]); (7) delirium severity (Memorial Delirium Assessment Scale [MDAS]); (8) adverse effects; and (9) quality of end-of-life care.
II. To identify novel predictive markers of response to haloperidol and lorazepam.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP I: Patients receive haloperidol intravenously (IV) over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP II: Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP III: Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
GROUP IV: Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (haloperidol, placebo) | Experimental | Drug: Haloperidol, Other: Placebo, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit. |
| Group II (lorazepam, placebo) | Experimental | Drug: Lorazepam, Other: Placebo, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit. |
| Group III (haloperidol, lorazepam) | Experimental | Drug: Haloperidol, Drug: Lorazepam, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit. |
| Group IV (placebo, lorazepam) | Experimental | Drug: Lorazepam, Other: Placebo, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- [Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
- [Patients] Admitted to the acute palliative care unit‡
- [Patients] Delirium as per DSM-5 criteria
- [Patients] Hyperactive or mixed delirium with RASS ≥1* in the past 24 h despite efforts to treat potential underlying causes
- [Patients] On scheduled haloperidol for delirium (≤8 mg in the past 24 h) or required ≥4 mg of rescue haloperidol for agitation in the past 24 h
Key exclusion criteria (6 listed)
- [Patients] History of myasthenia gravis or acute narrow angle glaucoma
- [Patients] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
- [Patients] History of Parkinson's disease, Alzheimer's or Lewy body dementia
- [Patients] History of prolonged QTc or QTcF interval (>500 ms)† if documented by most recent ECG within the past month
- [Patients] History of hypersensitivity to haloperidol or lorazepam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolAlso: Haldol, McN-JR-1625, R 1625, R-1625Given IV | Drug | Group I (haloperidol, placebo), Group III (haloperidol, lorazepam) |
| LorazepamAlso: AtivanGiven IV | Drug | Group II (lorazepam, placebo), Group III (haloperidol, lorazepam), Group IV (placebo, lorazepam) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven IV | Other | Group I (haloperidol, placebo), Group II (lorazepam, placebo), Group IV (placebo, lorazepam) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (haloperidol, placebo), Group II (lorazepam, placebo), Group III (haloperidol, lorazepam), Group IV (placebo, lorazepam) |
| Questionnaire AdministrationAncillary studies | Other | Group I (haloperidol, placebo), Group II (lorazepam, placebo), Group III (haloperidol, lorazepam), Group IV (placebo, lorazepam) |
Primary outcome
Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU)
Time frame: Baseline to 24 hours
The effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal will be compared on the change in the RASS score over 24 hours in patients admitted to an APCU who do not respond to low-dose haloperidol.(RASS between -2 and 0) Will use 2-sided t-tests for four pre-specified paired comparisons, if the required assumptions for this model are met. Non-parametric methods such as Wilcoxon rank-sum test may be used if any assumptions are violated.
10 secondary outcomes
Rescue medication use
Time frame: At 24 hours
Proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of >= 1.5 points)
Time frame: At 24 hours
Perceived comfort as assessed by caregivers and bedside nurses questionnaire
Time frame: At 24 hours
Delirium-related distress in caregivers and nurses assessed using Delirium Experience Questionnaire
Time frame: At 24 hours
Proxy comfort goal level
Time frame: Up to 24 hours
Symptom expression assessed using Edmonton Symptom Assessment Scale
Time frame: At 24 hours
Delirium severity assessed using Memorial Delirium Assessment Scale
Time frame: At 24 hours
Incidence of adverse events
Time frame: Up to 24 hours
Quality of end-of-life care: questionnaire
Time frame: 4-8 weeks
To identify novel predictive markers of response to haloperidol and lorazepam.
Time frame: Up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 40742738Hui D, De La Rosa A, Tsai JS, Cheng SY, Del Fabbro E, Thomas Kuzhiyil AT, Rowe K, Azhar A, Nguyen T, Tang M, Yao CA, Huang HL, Peng JK, Hu WY, Admane S, Dev R, Chen M, Bramati P, Shete S, Bruera E. Proportional Sedation for Persistent Agitated Delirium in Palliative Care: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1031-1043. doi: 10.1001/jamaoncol.2025.2212.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hui principal investigator
M.D. Anderson Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Haloperidol, Lorazepam and Quality-of-Life Assessment in people with Delirium and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU) (time frame: Baseline to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03743649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.