Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

NCT05674240 | Completed FDA Drug FDA Device

• 1 other identifier: IRB00104840
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain; Chronic Pain; Cancer Associated Pain; Neuropathic Pain

Keywords

targeted drug delivery; cancer pain; conservative pain management; neuromodulation; opioid; healthcare-utilization; quality of life

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  3-Months

Secondary Outcomes (5)

• Change in Drug Adverse Levels

  3-Months

• Change in Oral Opioid Intake

  3-Months

• Change in Healthcare Utilization

  3-Months

• Change in Patient Well-Being

  3-Months

• Change in Patient Global Impression Change

  3-Months

Other Outcomes (17)

• Change in Pain Intensity

  2-Months

• Change in Pain Interference

  2-Months

• Change in Drug Adverse Levels

  2-Months

Study Arms (2)

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

Combination Product: Conservative medical management

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

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

Interventions

Intrathecal Targeted Drug Delivery DEVICE

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

Also known as: Medtronic SynchroMed™ II pump

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

Conservative medical management COMBINATION_PRODUCT

Including physical therapy, oral or transdermal medications and injections

Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM; Cancer associated pain treated with conservative medical management (CMM) only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 169 subjects with cancer-associated pain who are going to be treated either with conservative medical management (CMM) only or with Intrathecal Drug Delivery along with CMM per treatment plan.

You may qualify if:

• 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

You may not qualify if:

• Active infections
• Controlled pain without adverse side effects that are limiting day to day function
• Mechanical barriers
• Obstruction of Cerebrospinal Fluid (CSF)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Aurora Health

Oshkosh, Wisconsin, 54904, United States

Location

MeSH Terms

Conditions

Cancer Pain; Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Lauren Littlefield, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 6, 2023
• Study Start: December 6, 2022
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)