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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02578459
• Other study ID #: PM-02
• Status: Withdrawn
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2018
• Source: Flowonix Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Pain Management
• Pancreatic Neoplasms

Intervention

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.

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 used to treat pancreatic cancer pain.

Locations

Country	Name	City	State
United States	Menorah Medical Center	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Flowonix Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival Rates	Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.	Two years
Secondary	Quality of Life Scores	Difference in quality of life between treatment groups.	Two years
Secondary	Cancer Treatments	Difference between treatment group in the number of cancer treatment initiated during the study	Two years
Secondary	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
Secondary	Adverse Events	Adverse events reported by each treatment group will be summarized.	Two years

External Links

•   Dr. Daniel R. Kloster
•   Dr. Jaswinder Singh