Pilot Study Comparing Treatment With Dexmedetomidine to Midazolam for Symptom Control in Advanced Cancer Patients
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Purpose
Cancer patients with very difficult to control symptoms at the Abbotsford (AC) and Fraser Valley (FVC) Cancer Centers are referred and admitted to the Tertiary Palliative Care Units at the Abbotsford Regional Hospital and Cancer Center(ARHCC). For symptom management, patients are sometimes given midazolam continuously through a needle placed underneath the skin. While effective in symptom management, midazolam can be sedating, leaving patients unable to interact with loved ones in their last days.
This study is a pilot project. Before proceeding to a full-scale study, a "pilot study" or "feasibility study" is often carried out first to test the design of a study, the likelihood of successful recruitment or the acceptability of the intervention to potential subjects. The basic idea is to find out whether it will be practical to proceed to a larger study that will include more subjects. This type of study involves only a small number of subjects and therefore the results can only be used as a guide for further larger studies.
The investigators also will determine whether palliative care cancer patients taking a medication called dexmedetomidine would have improved rousability (more easily and fully awakened) and symptom control (pain, shortness of breath, nausea or confusion) compared with those taking standard of care which is receiving the medication midazolam. The use of dexmedetomidine in other clinical situations (in the Operating Room or Intensive Care Unit where the patient can still respond to the doctor) has been shown to be effective in symptom control and to provide a better degree of rousability to patients but has not been well studied in the palliative care environment.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Intractable Delirium Dyspnea Nausea |
Drug: Dexmedetomidine Drug: Midazolam |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Dexmedetomidine Compared to Midazolam for Symptom Control in Advanced Cancer Patients: A Pilot Randomized Controlled Trial (RCT) |
- Number of subjects needed to recruit for a multicenter double blind randomized controlled phase III trial comparing dexmedetomidine to midazolam for symptom control in advanced cancer patients [ Time Frame: one year ] [ Designated as safety issue: No ]
Sample size determination for significant improvement in:
- Pain
- Dyspnea
- Nausea
- Delirium
- Rousability
- Change in pain (0 to 10 numerical scale) [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]Pain will be evaluated using the Edmonton Symptom Assessment Scale (ESASr)
- Change in dyspnea (0 to 10 numerical scale) [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]Dyspnea will be evaluated using the Edmonton Symptom Assessment Scale (ESASr)
- Change in nausea (0 to 10 numerical scale) [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]Nausea will be evaluated using the Edmonton Symptom Assessment Scale (ESASr)
- Change in delirium (16 item clinician rated scale) [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]Delirium will be assessed using the Delirium Rating Scale-Revised-98 (DRS-R-98)
- Rousability (10 point scale) [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]Rousability will be measured using the Richmond Agitation and Sedation Scale (RASS)
- Acceptable symptom control (yes/no) [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]Acceptable symptom control of the difficult to control or intractable symptoms of pain, dyspnea, nausea or delirium will be assessed by a two part question addressed to each of subject, family member and assigned palliative care nurse. Subjective responses will be collected from each as binary variables (0/1) with two positive responses indicating acceptable symptom control overall.
- Time to enroll 20 subjects [ Time Frame: One year ] [ Designated as safety issue: No ]This information will be used to determine accrual rate. The accrual rate and the primary outcome measure of number needed to recruit will be used to determine the number of sites required for a multi-center double blind randomized controlled Phase III trial comparing dexmedetomidine to midazolam for symptom control in advanced cancer patients.
- Cost determination for developing a budget for a large multi-center trial [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dexmedetomidine
Dexmedetomidine 0.2 to 1.1 mcg/kg/hr by continuous subcutaneous infusion for up to 10 days
|
Drug: Dexmedetomidine
Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.
Other Names:
|
|
Active Comparator: Midazolam
Midazolam 10 to 100 mcg/kg/hr by continuous subcutaneous infusion for up to 10 days
|
Drug: Midazolam
Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.
Other Name: DIN 02240286
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater or equal to 19 years of age
- Advanced cancer patient admitted to the Abbotsford Tertiary Palliative Care Unit
- Difficult to control or intractable symptom (REF 38, page 3)
- Midazolam CSCI would normally be considered for symptom management
- Informed consent is able to be provided in the English language
- Goals of care include do not resuscitate (DNR)
- For intractable symptoms, patient would prefer proportional sedation rather than no sedation or total sedation.
Exclusion Criteria:
- Second or third degree heart block (without pacemaker)
- Uncompensated congestive heart failure
- Heart rate less than 50 beats per minute
- Mean arterial blood pressure (MAP) < 60
- Weight below 35 kg. or above 85 kg.
- Prior use within the preceding 14 days of high dose benzodiazepines equivalent to the use of 30 mg or more of midazolam or 6 mg or more of lorazepam per 24 hours.
- Currently enrolled in any other research study involving drugs or devices
Contacts and Locations| Contact: Neil K Hilliard, MD | 604-851-4700 ext 642921 | Neil.Hilliard@fraserhealth.ca |
| Canada, British Columbia | |
| Abbotsford Regional Hospital and Cancer Center | Recruiting |
| Abbotsford, British Columbia, Canada, V2S 0C2 | |
| Contact: Stuart Brown, MD 604-851-4798 | |
| Contact: Neil K Hilliard, MD 604-851-4700 ext 642921 | |
| Principal Investigator: | Neil K Hilliard, MD | 1. BC Cancer Agency 2. Fraser Health Authority |
| Principal Investigator: | Stuart Brown, MD | Fraser Health Authority |
More Information
Publications:
| Responsible Party: | Fraser Health |
| ClinicalTrials.gov Identifier: | NCT01687751 History of Changes |
| Other Study ID Numbers: | FHREB 2012-057 |
| Study First Received: | August 29, 2012 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Fraser Health:
|
feasibility studies conscious sedation/ dexmedetomidine/ midazolam/ infusions, subcutaneous/ palliative care/ terminal care/ terminally ill/ |
neoplasms/ treatment outcome Precedex "end of life" Dying Advanced cancer mood/delirium/delirious |
Additional relevant MeSH terms:
|
Delirium Dyspnea Nausea Neoplasms Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms, Digestive |
Midazolam Dexmedetomidine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 23, 2013