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Completed

NCT Number: NCT05674240

Prospective Evaluation of 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.

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Key information

Conditions

Cancer Pain Cancer Associated Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advocate Aurora Health

Oshkosh, Wisconsin, 54904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intrathecal Targeted Drug Delivery

Device

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

Other names: Medtronic SynchroMed™ II pump

Conservative medical management

Combination Product

Including physical therapy, oral or transdermal medications and injections

Primary outcomes

  1. Change in Pain Intensity from Screening through 3-Months

    Time frame: 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)

  2. Change in Pain Interference from Screening through 3-Months

    Time frame: 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 outcomes

  1. Change in Drug Adverse Levels

    Time frame: 3-Months

    Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria

  2. Change in Oral Opioid Intake

    Time frame: 3-Months

    Average change from baseline to 3-Months in oral opioid intake

  3. Change in Healthcare Utilization

    Time frame: 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

  4. Change in Patient Well-Being

    Time frame: 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)

  5. Change in Patient Global Impression Change

    Time frame: 3-Months

    Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

Other outcomes

  1. Change in Pain Intensity

    Time frame: 2-Months

    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. Change in Pain Interference

    Time frame: 2-Months

    Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  3. Change in Drug Adverse Levels

    Time frame: 2-Months

    Average change from baseline to 2-Months in drug adverse levels as assessed through the Common Toxicity Criteria

  4. Change in Oral Opioid Intake

    Time frame: 2-Months

    Average change from baseline to 2-Months in oral opioid intake

  5. Change in Patient Well-Being

    Time frame: 2-Months

    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)

  6. Change in Patient Global Impression Change

    Time frame: 2-Months

    Average change from baseline to 2-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

  7. Change in Pain Intensity

    Time frame: 1-Month

    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)

  8. Change in Pain Interference

    Time frame: 1-Month

    Change from baseline to 1-Month post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  9. Change in Drug Adverse Levels

    Time frame: 1-Month

    Average change from baseline to 1-Month in drug adverse levels as assessed through the Common Toxicity Criteria

  10. Change in Oral Opioid Intake

    Time frame: 1-Month

    Average change from baseline to 1-Month in oral opioid intake

  11. Change in Patient Well-Being

    Time frame: 1-Month

    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)

  12. Change in Patient Global Impression Change

    Time frame: 1-Month

    Average change from baseline to 1-Month in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

  13. Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI)

    Time frame: 6-Months

  14. Average change from baseline to 6-Months in oral opioid intake

    Time frame: 6-Months

  15. 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

    Time frame: 6-Months

  16. Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire

    Time frame: 6-Months

  17. Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire

    Time frame: 6-Months

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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