Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Wake Forest University (WFU)

Status: Active, not recruiting

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

Treatments: Device: Intrathecal Targeted Drug Delivery; Combination Product: Conservative medical management

Study type: Observational

Funder types: Other

Identifiers

NCT05674240

IRB00104840

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 2 patient groups

Cancer associated pain treated with conservative medical management (CMM) only

Description:

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

Treatment:

Combination Product: Conservative medical management

Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM

Description:

Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain

Treatment:

Combination Product: Conservative medical management

Device: Intrathecal Targeted Drug Delivery