Managing agitated delirium in cancer patients with neuroleptics and anti-epileptics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of haloperidol, chlorpromazine, and valproate, compared to a placebo, on managing agitated delirium in hospitalized cancer patients. It employs a double-blind, randomized design to assess the frequency of breakthrough restlessness and various delirium-related outcomes over a 72-hour period. The study also evaluates the efficacy of non-pharmacologic interventions alone in alleviating symptoms of delirium. The goal is to provide evidence for effective treatment options that can improve patient comfort and reduce caregiver distress.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
2. \[Patients\] Seen by palliative care inpatient consultation team
3. \[Patients\] Delirium as per DSM-5 criteria
4. \[Patients\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium
5. \[Patients\] Age 18 years or older
6. \[Patients\] Permission from clinician from primary team to enroll
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 Criteria:

1. \[Patients\] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d
2. \[Patients\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
3. \[Patients\] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month)
4. \[Patients\] History of neuroleptic malignant syndrome as documented in chart
5. \[Patients\] Active seizure disorder within past month as documented in chart
6. \[Patients\] History of Parkinson's disease or dementia as documented in chart
7. \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by most recent ECG within the past month
8. \[Patients\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart
9. \[Patients\] Pancreatitis within past month as documented in chart
10. \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine
11. \[Patients\] Physical signs of impending death such as respiration with mandibular movement and death rattle
12. \[Patients\] Pregnancy as documented in chart
13. \[Patients\] Active COVID-19 infection as documented in chart

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: David Hui, MD — M.D. Anderson Cancer Center
• Study coordinator: David Hui, MD
• Email: dhui@mdanderson.org
• Phone: (713) 792-6258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.