NCT05674240

Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Pain
• Chronic Pain
• Cancer Associated Pain
• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Intrathecal Targeted Drug Delivery	Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
COMBINATION_PRODUCT	Conservative medical management	Including physical therapy, oral or transdermal medications and injections

Timeline

• Start date: 2022-12-06
• Primary completion: 2026-03-20
• Completion: 2026-03-20
• First posted: 2023-01-06
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study