Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
Overview[ - collapse ][ - ]
| Purpose | The goal of this clinical research study is to learn if giving lorazepam in combination with haloperidol can help to control the symptoms of delirium in patients with advanced cancer. The safety of this drug combination will also be studied. In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. |
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| Condition | Advanced Cancers |
| Intervention | Drug: Lorazepam Drug: Placebo Drug: Haloperidol decanoate Behavioral: Questionnaires |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Responsible Party | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier | NCT01949662 |
| First Received | September 20, 2013 |
| Last Updated | March 6, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 20, 2013 |
|---|---|
| Last Updated Date | March 6, 2014 |
| Start Date | January 2014 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Control of Delirium Symptoms [Time Frame: 8 hours] [Designated as safety issue: No]Delirium symptoms rated by intensity of agitation scores (Richmond Agitation Sedation Scale - RASS) over 8 hours. Comparisons between arms performed using linear mixed models accounting for within patient correlations across time (RASS), t-tests and Mann-Whitney tests. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer |
|---|---|
| Official Title | A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit |
| Brief Summary | The goal of this clinical research study is to learn if giving lorazepam in combination with haloperidol can help to control the symptoms of delirium in patients with advanced cancer. The safety of this drug combination will also be studied. In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. |
| Detailed Description | Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups: - If you are in Group 1, you will receive lorazepam. - If you are in Group 2, you will receive a placebo. Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving. You will have an equal chance of being in each group. All patients will receive haloperidol as part of your standard of care. The study doctor can tell you more about haloperidol, how it is designed to work, and about any side effects it may have. Study Drug Administration: After you have started receiving haloperidol, you will receive lorazepam or the placebo by vein 1 time over about 1-2 minutes. Study Tests: Every day while you are in the palliative care unit, you will be asked to complete the same questionnaires about symptoms and how you are feeling that you were asked at screening. If at any point you recover from your confusion, you will be asked if you remember the confusion and how distressing it was. Length of Study: You will receive the study drug or placebo 1 time. You will be monitored as part of this study until you leave the palliative care unit. You may go off study at any time that you/your caregiver decides it is in your best interest. This is an investigational study. Lorazepam is FDA approved and commercially available for the treatment of anxiety, insomnia, and seizures. Its use to help control agitation/delirium is investigational. Up to 34 patients will take part in this study. All will be enrolled at MD Anderson. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care |
| Condition | Advanced Cancers |
| Intervention | Drug: Lorazepam 3 mg by vein one time only. Drug: Placebo Placebo consisting of preservative free 0.9% normal saline given one time by vein. Drug: Haloperidol decanoate 8 mg/day by vein. Behavioral: Questionnaires Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete. Other Names: Surveys |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 34 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | January 2017 |
| Eligibility Criteria | Inclusion Criteria: 1. [Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease) 2. [Patients] Admitted to Acute Palliative Care Unit (APCU) 3. [Patients] Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria 4. [Patients] Hyperactive/mixed delirium with RASS >/=2 in the last 24 hours 5. [Patients] Memorial delirium rating scale >/=13 6. [Patients] On scheduled haloperidol of <8 mg in the last 24 hours 7. [Patients] Age 18 or older 8. [Patients] Legally Authorized Representative consent 9. [Family Caregivers] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner) 10. [Family Caregivers] Age 18 or older 11. [Family Caregivers] At the patient's bedside at least 4 hours each day during patient delirium episode 12. [Family Caregivers] Able to communicate in English Exclusion Criteria: 1. [Patients] Life expectancy <3 days (based on clinical signs of impending death) 2. [Patients] History of myasthenia gravis, acute narrow angle glaucoma, or hepatic encephalopathy 3. [Patients] History of neuroleptic malignant syndrome 4. [Patients] History of Parkinson's disease or dementia 5. [Patients] History of seizure disorder 6. [Patients] History of hypersensitivity to haloperidol or benzodiazepine 7. [Patients] On regular doses of benzodiazepine or chlorpromazine within the past 48 hours 8. [Patients] Previously documented and persistent QTc prolongation (>500 ms) 9. [Patients] Heart failure exacerbation at the time of enrollment |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: David Hui, MD 713-792-6085 |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01949662 |
|---|---|
| Other Study ID Numbers | 2013-0345 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | M.D. Anderson Cancer Center |
| Study Sponsor | M.D. Anderson Cancer Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: David Hui, MD M.D. Anderson Cancer Center |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| University of Texas MD Anderson Cancer Center | Houston, Texas, United States, 77030 Recruiting |
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