Cancer Pain, Pain Management
Conditions
Keywords
Cancer pain, Intrathecal therapy, Pain, Pancreatic cancer
Brief summary
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.
Detailed description
This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain. There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain. A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.
Interventions
DEVICEIntrathecal Drug Delivery System
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.
Sponsors
Flowonix Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has Stage IV pancreatic cancer. 2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study. 3. Patient agrees not to obtain pain medications from other physicians during the study. 4. Patient is at least 22 years of age. 5. Investigator considers the patient to be able and willing to fulfill all study requirements. 6. Patient is able to understand the study and provide written informed consent to participate in the study.
Exclusion criteria
1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group). 2. Patient is enrolled in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Scores | Three months | Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations and Emergency Room Visits | Two years | Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study |
| Survival Rates | Two years | Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type. |
| Quality of Life Scores | Two years | Difference in quality of life between treatment groups. |
| Cancer Treatments | Two years | Difference between treatment group in the number of cancer treatment initiated during the study |
| Adverse Events | Two years | Adverse events reported by each treatment group will be summarized. |
Countries
United States
Outcome results
None listed