Haloperidol + Lorazepam for Cancer-related Delirium
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well two medications, haloperidol and lorazepam, manage symptoms of agitated delirium in cancer patients receiving palliative care. The researchers aim to determine if these treatments can ease the distress caused by delirium, benefiting both patients and their caregivers. Participants will receive either haloperidol, lorazepam, a combination of the two, or a placebo for comparison. This trial suits those with advanced cancer experiencing persistent delirium that hasn't improved with usual treatments. As a Phase 2 and Phase 3 trial, this research evaluates the treatments' effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been on scheduled lorazepam in the past 48 hours.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that haloperidol and lorazepam can be well-tolerated in treating delirium in patients with advanced cancer. One study found that haloperidol is generally safe, though it may not always effectively treat delirium. Another study demonstrated that lorazepam significantly reduces agitation, making it a good option for calming symptoms.
When used together, haloperidol and lorazepam have shown promising results. A comprehensive analysis found that this combination had the highest success rate for treating delirium. Additionally, another study noted a significant decrease in agitated delirium when patients received both medications.
Overall, while some caution is advised, especially for older patients, both drugs have been shown to be safe when used correctly. This suggests that using both medications together could be a helpful option for managing delirium symptoms in cancer patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for cancer-related delirium because they involve two well-known medications, haloperidol and lorazepam, in novel combinations. Haloperidol is typically used to manage psychotic disorders, while lorazepam is commonly used for anxiety. In this trial, these medications are being administered intravenously and in combination, offering potentially faster relief for patients experiencing delirium. This approach could provide a more effective and rapid treatment option for managing delirium in palliative care settings compared to traditional methods, which often rely on singular treatments.
What evidence suggests that this trial's treatments could be effective for cancer-related delirium?
Research has shown that both haloperidol and lorazepam can ease symptoms of agitated delirium in cancer patients, particularly those in palliative care. In this trial, participants will join different treatment groups to evaluate these medications. Some will receive lorazepam, either alone or with haloperidol. Studies have found that this combination significantly reduces agitation more than haloperidol alone or a placebo. Reports indicate that using both haloperidol and lorazepam together greatly reduces symptoms, especially in the first 8 to 24 hours. Patients using these treatments have experienced a noticeable decrease in restlessness and agitation related to end-of-life delirium. These findings suggest that these medications can effectively manage symptoms and improve comfort for cancer patients dealing with delirium.34678
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 persistent agitated delirium, despite treatment efforts. They must be admitted to a palliative care unit and have been on haloperidol or required it for agitation. Excluded are those with certain neurological disorders, history of severe reactions to the drugs being tested, or specific heart rhythm abnormalities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive haloperidol and/or lorazepam intravenously every 4 hours and then every hour as needed until discharge from the palliative care unit
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Haloperidol
- Lorazepam
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