Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neuropathic Pain; Cancer Pain; Cancer Associated Pain
• Intervention / Treatment: Combination product: Conservative medical management; Device: Intrathecal Targeted Drug Delivery

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Oshkosh, Wisconsin, United States, 54904
      • Advocate Aurora Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Including physical therapy, oral or transdermal medications and injections
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	Combination product: Conservative medical management; Including physical therapy, oral or transdermal medications and injections; Device: Intrathecal Targeted Drug Delivery; Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.; Other Names: Medtronic SynchroMed™ II pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oral Opioid Intake	Average change from baseline to 3-Months in oral opioid intake	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	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)	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)	3-Months
Change in Drug Adverse Levels	Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria	3-Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	Change from baseline to 2-Months post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)	2-Months
Change in Pain Interference	Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)	2-Months
Change in Oral Opioid Intake	Average change from baseline to 2-Months in oral opioid intake	2-Months
Change in Patient Well-Being	Average change from baseline to 2-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)	2-Months
Change in Patient Global Impression Change	Average change from baseline to 2-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)	2-Months
Change in Pain Intensity	Change from baseline to 1-Month post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)	1-Month
Change in Pain Interference	Change from baseline to 1-Month post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)	1-Month
Change in Oral Opioid Intake	Average change from baseline to 1-Month in oral opioid intake	1-Month
Change in Patient Well-Being	Average change from baseline to 1-Month in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)	1-Month
Change in Patient Global Impression Change	Average change from baseline to 1-Month in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)	1-Month
Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI)		6-Months
Average change from baseline to 6-Months in oral opioid intake		6-Months
Average change from baseline to 6-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain and length of hospital stays		6-Months
Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire		6-Months
Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire		6-Months
Change in Drug Adverse Levels	Average change from baseline to 2-Months in drug adverse levels as assessed through the Common Toxicity Criteria	2-Months
Change in Drug Adverse Levels	Average change from baseline to 1-Month in drug adverse levels as assessed through the Common Toxicity Criteria	1-Month

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Lauren Littlefield, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): March 20, 2026
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: opioid; quality of life; neuromodulation; cancer pain; targeted drug delivery; conservative pain management; healthcare-utilization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cancer Pain; Chronic Pain; Neuralgia
• Other Study ID Numbers: IRB00104840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes