← Back to all trials
Active Not Recruiting
NCT03021486
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
Conditions: Advanced Malignant Neoplasm, Delirium, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 70
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
Summary
This randomized phase II/III trial studies how well haloperidol with or without chlorpromazine works in treating delirium in patients with cancer that has spread to other parts of the body or has come back. Haloperidol and chlorpromazine may control the symptoms of delirium (loss of contact with reality) in patients with cancer.
Eligibility Criteria
Inclusion:
1. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
2. \[Patients\] Admitted to the acute palliative care unit
3. \[Patients\] Delirium as per DSM-V criteria (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5))
4. \[Patients\] Hyperactive or mixed delirium with RASS \>/=1 in the past 24 h (RASS\>/=+1 indicates any degree of restlessness. In the electronic medical record nursing note, this behavior would be indicated by any documentation of "restless", "agitated", "hyperactive", "pulling on devices/IV" or similar wording).
5. \[Patients\] On scheduled haloperidol for delirium (\/=4 mg for restlessness/agitation in the past 24 h
6. \[Patients\] Age 18 years or older
7. \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
8. \[Family Caregivers\] Age 18 years or older
Exclusion:
1. \[Patients\] History of myasthenia gravis or acute narrow angle glaucoma
2. \[Patients\] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
3. \[Patients\] History of Parkinson's disease or Alzheimer's dementia
4. \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by ECG within the past month
5. \[Patients\] History of hypersensitivity to haloperidol or chlorpromazine
6. \[Patients\] On scheduled chlorpromazine within the past 48 h
Source: ClinicalTrials.gov (NCT03021486). StuddyBuddy aggregates publicly available trial information.