Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Study Overview
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Brief Summary
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This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.

Detailed Description
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This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress. Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3 months post-implant.

Official Title
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Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Conditions
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Cancer Pain, Chronic Pain, Cancer Associated Pain, Neuropathic Pain

Intervention / Treatment
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* Device: Intrathecal Targeted Drug Delivery
* Combination Product: Conservative medical management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 21 and older Uncontrolled cancer-associated pain (pain score of >5 on NRS) despite oral use of 60 mg/d morphine equivalent a week prior to screening Adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function Life expectancy of > 3 months Exclusion Criteria: Active infections Controlled pain without adverse side effects that are limiting day to day function Mechanical barriers Obstruction of Cerebrospinal Fluid (CSF)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer associated pain treated with conservative medical management (CMM) only<br>Subjects in this group are patients who opted for conservative medical management for their chronic pain that is cancer associated, including physical therapy, oral or transdermal medications and injections | Combination Product: Conservative medical management<br>* Including physical therapy, oral or transdermal medications and injections<br>|
| Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM<br>Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain | Device: Intrathecal Targeted Drug Delivery<br>* Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.<br>* Other names: Medtronic SynchroMed™ II pump;Combination Product: Conservative medical management<br>* Including physical therapy, oral or transdermal medications and injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity from Screening through 3-Months | Change from baseline to Month 3 post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome) | 3-Months | 
| Change in Pain Interference from Screening through 3-Months | Change from baseline to Month 3 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29) | 3-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Drug Adverse Levels | Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria | 3-Months | 
| Change in Oral Opioid Intake | Average change from baseline to 3-Months in oral opioid intake | 3-Months | 
| Change in Healthcare Utilization | Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain | 3-Months | 
| Change in Patient Well-Being | Average change from baseline to 3-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome) | 3-Months | 
| Change in Patient Global Impression Change | Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome) | 3-Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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targeted drug delivery, cancer pain, conservative pain management, neuromodulation, opioid, healthcare-utilization, quality of life