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

Flowonix Medical

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Pain Management Cancer Pain

Interventions

Intrathecal Drug Delivery SystemDEVICE

The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.

Conventional Medical ManagementOTHER

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (1)

Menorah Medical Center

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Three months

Secondary Outcomes

Survival Rates

Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.

Time frame: Two years

Quality of Life Scores

Difference in quality of life between treatment groups.

Time frame: Two years

Cancer Treatments

Difference between treatment group in the number of cancer treatment initiated during the study

Time frame: 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

Time frame: Two years

Adverse Events

Adverse events reported by each treatment group will be summarized.

Time frame: Two years

Data from ClinicalTrials.gov

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