Advanced CancersPhase 2NCT01949662
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
A Phase 2 study testing Lorazepam, Haloperidol decanoate and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Lorazepam, Haloperidol decanoate and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 1 Jan 2028
- Phase
- Phase 2
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)
- Admitted to Acute Palliative Care Unit (APCU)
- Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV- TR) criteria
- Hyperactive/mixed delirium with RASS >= 2 in the last 24 hours
- On scheduled haloperidol of =< 8 mg in the last 24 hours
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- Legally authorized representative consent
- FAMILY CAREGIVERS:
- Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
- Age 18 or older
- At the patient's bedside at least 4 hours each day during patient delirium episode
- Patients and family caregivers able to communicate in English or Spanish
Who cannot join
- PATIENTS
- History of myasthenia gravis or acute narrow angle glaucoma
- History of neuroleptic malignant syndrome
- History of Parkinson's disease or dementia
- Uncontrolled seizure disorder
- History of hypersensitivity to haloperidol or benzodiazepine
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- On regular doses of benzodiazepine or chlorpromazine within the past 48 hours
- Previously documented and persistent corrected QT (QTc) prolongation (> 500 ms)
- Heart failure exacerbation at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Advanced Cancers
- Being tested
- Lorazepam, Placebo, Haloperidol decanoate, Questionnaires
- Keywords
- Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Neurotoxicity Syndrome, Questionnaires, Surveys, Acute palliative care unit
- Medical subject headings
- Delirium, Hematologic Neoplasms, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
3 mg by vein one time only.
PlaceboDrug
Placebo consisting of preservative free 0.9% normal saline given one time by vein.
Haloperidol decanoateDrug
8 mg/day by vein.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam + Haloperidol | Experimental | Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete Receives: Drug: Lorazepam; Drug: Haloperidol decanoate; Behavioral: Questionnaires |
| Placebo + Haloperidol | Active comparator | Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete Receives: Drug: Placebo; Drug: Haloperidol decanoate; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
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.
Measured: Baseline to 8 hours
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
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.
Measured: 8 hours
Secondary outcomes (2)
Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min
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.
Measured: Baseline to 30 minutes
Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr
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.
Measured: Baseline to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJan 2014
- Primary completion26 Aug 2016
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancersStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 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, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949662
- Sponsor's protocol ID
- 2013-0345
- Other IDs
- NCI-2013-02351, 1R21CA186000-01A1
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2013
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hui D, Frisbee-Hume S, Wilson A, Dibaj SS, Nguyen T, De La Cruz M, Walker P, Zhukovsky DS, Delgado-Guay M, Vidal M, Epner D, Reddy A, Tanco K, Williams J, Hall S, Liu D, Hess K, Amin S, Breitbart W, Bruera E. Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1047-1056. doi: 10.1001/jama.2017.11468.
PubMed 28975307