Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain
NCT ID: NCT05674240
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
30 participants
OBSERVATIONAL
2022-12-06
2026-03-20
Brief Summary
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Detailed Description
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Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3- and 6- months post-implant.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer associated pain treated with conservative medical management (CMM) only
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
Conservative medical management
Including physical therapy, oral or transdermal medications and injections
Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM
Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain
Intrathecal Targeted Drug Delivery
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
Conservative medical management
Including physical therapy, oral or transdermal medications and injections
Interventions
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Intrathecal Targeted Drug Delivery
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
Conservative medical management
Including physical therapy, oral or transdermal medications and injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Controlled pain without adverse side effects that are limiting day to day function
* Mechanical barriers
* Obstruction of Cerebrospinal Fluid (CSF)
21 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Lauren Littlefield, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Advocate Aurora Health
Oshkosh, Wisconsin, United States
Countries
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Other Identifiers
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IRB00104840
Identifier Type: -
Identifier Source: org_study_id
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