Managing agitated delirium in cancer patients with neuroleptics and anti-epileptics
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
This study is testing if certain medications can help calm down cancer patients who are experiencing agitation and confusion while in the hospital.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05431595 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced cancer and diagnosed with hyperactive or mixed delirium.
Not a fit: Patients currently on high doses of haloperidol, chlorpromazine, or valproate, or those with specific contraindications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of agitated delirium in cancer patients, enhancing their comfort and quality of life.
How similar studies have performed: Other studies have shown promise in using neuroleptics and anti-epileptics for delirium management, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.