Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
Condition: Advanced Cancers
MeSH terms: Neoplasms; Delirium
Intervention: Lorazepam; Placebo; Haloperidol decanoate; Questionnaires
Intervention description: 3 mg by vein one time only.; Placebo consisting of preservative free 0.9% normal saline given one time by vein.; 8 mg/day by vein.; Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.
Intervention MeSH terms: Lorazepam; Haloperidol; Haloperidol decanoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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. 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  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

        Exclusion Criteria:

          -  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

          -  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