A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

Conditions
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Pain Management, Cancer Pain

Intervention / Treatment
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* Device: Intrathecal Drug Delivery System
* Other: Conventional Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has Stage IV pancreatic cancer. Patient agrees not to be treated by other oncologists or anesthesiologists during the study. Patient agrees not to obtain pain medications from other physicians during the study. Patient is at least 22 years of age. Investigator considers the patient to be able and willing to fulfill all study requirements. Patient is able to understand the study and provide written informed consent to participate in the study. Exclusion Criteria: Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group). Patient is enrolled in another clinical study.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal Drug Delivery (ITDD)<br>These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. | Device: Intrathecal Drug Delivery System<br>* The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.<br>* Other names: Prometra Programmable Infusion System;|
| Active Comparator: Conventional Medical Management (CMM)<br>These subjects will be treated with conventional medical management to treat their pain. | Other: Conventional Medical Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Scores | 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. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rates | Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type. | Two years | 
| Quality of Life Scores | Difference in quality of life between treatment groups. | Two years | 
| Cancer Treatments | Difference between treatment group in the number of cancer treatment initiated during the study | Two years | 
| Hospitalizations and Emergency Room Visits | Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study | Two years | 
| Adverse Events | Adverse events reported by each treatment group will be summarized. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer pain, Intrathecal therapy, Pain, Pancreatic cancer