Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Active, not recruiting

• Conditions: Chronic Pain; Neuropathic Pain; Cancer Pain; Cancer Associated Pain

• Registration Number: NCT05674240
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Study Start: 2022-12-06
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-01-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity from Screening through 3-Months	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)
Change in Pain Interference from Screening through 3-Months	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)

Secondary Outcome Measures

Name	Time	Method
Change in Oral Opioid Intake	3-Months	Average change from baseline to 3-Months in oral opioid intake
Change in Patient Well-Being	3-Months	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)
Change in Patient Global Impression Change	3-Months	Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
Change in Drug Adverse Levels	3-Months	Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria
Change in Healthcare Utilization	3-Months	Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain

Trial Locations

Locations (1)

Advocate Aurora Health; 🇺🇸 Oshkosh, Wisconsin, United States