A Pilot Study To Evaluate The Efficacy Of ITDD Vs. CMM In The Treatment Of Pancreatic Cancer Pain

Study Overview

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

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.

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.

Pain Management
Cancer Pain

DEVICE: Intrathecal Drug Delivery System
OTHER: Conventional Medical Management

PM-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-02-13
First Submitted that Met QC Criteria 2015-10-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-02-15
First Posted (ACTUAL) 2015-10-19	Results First Posted N/A	Last Verified 2018-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intrathecal Drug Delivery (ITDD) These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.	DEVICE: Intrathecal 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.
ACTIVE_COMPARATOR: Conventional Medical Management (CMM) These subjects will be treated with conventional medical management to treat their pain.	OTHER: Conventional Medical Management 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Intrathecal Drug Delivery (ITDD)

These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.

DEVICE: Intrathecal 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.

ACTIVE_COMPARATOR: Conventional Medical Management (CMM)

These subjects will be treated with conventional medical management to treat their pain.

OTHER: Conventional Medical Management

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
22 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Daniel R Kloster, MD, Menorah Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record