Haloperidol + Lorazepam for Delirium in Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether haloperidol, a common medication for confusion, with or without lorazepam, can better ease symptoms of delirium in patients with advanced cancer. Delirium includes issues like confusion and memory problems, and the trial aims to determine if these medications can help patients feel more comfortable. Participants have advanced cancer that cannot be controlled and are experiencing delirium in a palliative care unit. Those dealing with confusion and memory issues related to their cancer may find this trial relevant. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you have not taken regular doses of benzodiazepine or chlorpromazine in the past 48 hours. If you are on these medications, you may need to stop them before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using haloperidol and lorazepam together is generally safe for patients with advanced cancer. Studies have found that this combination can help reduce symptoms of agitated delirium, such as confusion and restlessness. Patients taking both medications often feel better within just a few hours.
Importantly, no major safety issues have been reported with this treatment combination in the available studies. The evidence suggests that adding lorazepam to haloperidol can effectively manage delirium symptoms without causing significant side effects. While every treatment can have side effects, the data supports the safety of using these drugs together for this condition.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for delirium in advanced cancer, which typically involves medications like haloperidol alone, this trial explores the combination of haloperidol with lorazepam. Researchers are excited about this approach because lorazepam, a benzodiazepine, may enhance the calming effects of haloperidol, potentially offering quicker relief from delirium symptoms. Additionally, this combination is administered intravenously, which could provide faster onset of action compared to oral medications. These features make the treatment potentially transformative for patients experiencing the distress of delirium in a palliative care setting.
What evidence suggests that this trial's treatments could be effective for delirium in advanced cancer?
In this trial, participants will receive either a combination of lorazepam and haloperidol or haloperidol with a placebo. Research has shown that lorazepam combined with haloperidol reduces agitation related to delirium more effectively than haloperidol alone. Lorazepam, whether used by itself or with haloperidol, significantly reduces agitation in patients with advanced cancer. One study found that adding lorazepam to haloperidol led to a greater decrease in agitation after 8 hours compared to using only haloperidol. This combination may better control delirium symptoms for those with ongoing issues. Overall, evidence supports that the combination of lorazepam and haloperidol manages agitation more effectively than haloperidol alone.36789
Who Is on the Research Team?
David Hui
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced cancer experiencing delirium, who are in a palliative care unit and have had hyperactive or mixed symptoms recently. They must be on low-dose haloperidol and not have conditions like myasthenia gravis, glaucoma, Parkinson's disease, dementia, uncontrolled seizures, or certain heart issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either lorazepam or placebo with haloperidol to assess the effect on delirium over an 8-hour period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Haloperidol
- Lorazepam
Trial Overview
The study is testing if adding lorazepam to haloperidol can better reduce delirium symptoms in patients with advanced cancer compared to using just haloperidol. Participants will be randomly assigned to receive either both drugs or only haloperidol alongside a placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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
Haloperidol is already approved in United States, European Union, Canada, Japan for the following indications:
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
- Tourette's syndrome
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
- Schizophrenia
- Acute psychosis
- Agitation
- Delirium
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1476O Haloperidol and lorazepam for agitated delirium in ...
Scheduled medications proactively reduced breakthrough agitation compared to placebo. Lorazepam and combination therapy were more effective than haloperidol.
Lorazepam significantly reduces agitation in patients with ...
Follow-up results show that lorazepam, alone or with haloperidol, significantly reduced agitation more than haloperidol alone or a placebo.
Effect of Lorazepam With Haloperidol vs ... - PubMed
The addition of lorazepam to haloperidol compared with haloperidol alone resulted in a significantly greater reduction in agitation at 8 hours.
Effect of Lorazepam With Haloperidol vs ...
The addition of lorazepam to haloperidol may provide superior control of agitation in patients with persistent delirium.
NCT03743649 | Haloperidol and Lorazepam in Controlling ...
Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may ...
6.
mdanderson.org
mdanderson.org/newsroom/esmo--combination-therapy-reduced-agitated-delirium-in-patients-with-advanced-cancers.h00-159700701.htmlCombination therapy reduced agitated delirium in patients ...
Patients that received the combination of haloperidol and lorazepam experienced a significant decrease in agitated delirium when measured at 24 ...
Effect of Lorazepam With Haloperidol vs ...
Lorazepam + haloperidol was associated with a significantly greater reduction in RASS score than placebo + haloperidol at 8 hours.
Lorazepam Added to Haloperidol Effective for Agitated ...
Using a single dose of lorazepam in combination with haloperidol decreases agitation in end-of-life patients with cancer who had persistent ...
Pharmacologic Management of End-of-Life Delirium
The authors concluded that both haloperidol and olanzapine were efficacious in reducing delirium symptoms in patients with advanced cancer.
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