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

Not Applicable

Withdrawn

• Conditions: Cancer Pain; Pain Management
• Interventions: Device: Intrathecal Drug Delivery System; Other: Conventional Medical Management

• Registration Number: NCT02578459
• Lead Sponsor: Flowonix Medical

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.

Study Timeline

• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2016-04
• Primary Completion: 2016-12
• Status Verified: 2018-07
• Study Completion: 2018-09
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal Drug Delivery (ITDD)	Intrathecal Drug Delivery System	These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
Conventional Medical Management (CMM)	Conventional Medical Management	These subjects will be treated with conventional medical management to treat their pain.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Scores	Three months	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

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

Trial Locations

Locations (1)

Menorah Medical Center; 🇺🇸 Overland Park, Kansas, United States