Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Wake Forest University Health Sciences30 enrolled

Overview

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.

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- and 6- months post-implant.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cancer Pain Chronic Pain Cancer Associated Pain Neuropathic Pain

Interventions

Intrathecal Targeted Drug DeliveryDEVICE

Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.

Conservative medical managementCOMBINATION_PRODUCT

Including physical therapy, oral or transdermal medications and injections

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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)

Locations (1)

Advocate Aurora Health

Oshkosh, Wisconsin, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 3-Months

Secondary Outcomes

Change in Drug Adverse Levels

Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria

Time frame: 3-Months

Change in Oral Opioid Intake

Average change from baseline to 3-Months in oral opioid intake

Time frame: 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

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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