Back to resultsA Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Primary Purpose
Pain Management, Cancer Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intrathecal Drug Delivery System
Conventional Medical Management
Sponsored by
About this trial
This is an interventional treatment trial for Pain Management focused on measuring Cancer pain, Intrathecal therapy, Pain, Pancreatic cancer
Eligibility Criteria
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.
Sites / Locations
- Menorah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intrathecal Drug Delivery (ITDD)
Conventional Medical Management (CMM)
Arm Description
These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
These subjects will be treated with conventional medical management to treat their pain.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Survival Rates
Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.
Quality of Life Scores
Difference in quality of life between treatment groups.
Cancer Treatments
Difference between treatment group in the number of cancer treatment initiated during the study
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
Adverse Events
Adverse events reported by each treatment group will be summarized.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02578459
Brief Title
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Official Title
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never initiated by sponsor. Patients where never recruited.
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flowonix Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management, Cancer Pain
Keywords
Cancer pain, Intrathecal therapy, Pain, Pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal Drug Delivery (ITDD)
Arm Type
Experimental
Arm Description
These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
Arm Title
Conventional Medical Management (CMM)
Arm Type
Active Comparator
Arm Description
These subjects will be treated with conventional medical management to treat their pain.
Intervention Type
Device
Intervention Name(s)
Intrathecal Drug Delivery System
Other Intervention Name(s)
Prometra Programmable Infusion System
Intervention Description
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
Intervention Type
Other
Intervention Name(s)
Conventional Medical Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale Pain Scores
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Survival Rates
Description
Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.
Time Frame
Two years
Title
Quality of Life Scores
Description
Difference in quality of life between treatment groups.
Time Frame
Two years
Title
Cancer Treatments
Description
Difference between treatment group in the number of cancer treatment initiated during the study
Time Frame
Two years
Title
Hospitalizations and Emergency Room Visits
Description
Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study
Time Frame
Two years
Title
Adverse Events
Description
Adverse events reported by each treatment group will be summarized.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel R Kloster, MD
Organizational Affiliation
Menorah Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://researchmedicalcenter.secure.ehc.com/physicians/profile/Jaswinder-Singh-MD
Description
Dr. Jaswinder Singh
Learn more about this trial
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
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