Clinical trial NCT05674240: Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain
Official title: Intrathecal Targeted Drug Delivery for Cancer Associated Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 169
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Pain Intensity from Screening through 3-Months
timeFrame: 3-Months
measure: Change in Pain Interference from Screening through 3-Months
timeFrame: 3-Months
Secondary outcomes:
measure: Change in Drug Adverse Levels
timeFrame: 3-Months
measure: Change in Oral Opioid Intake
timeFrame: 3-Months
measure: Change in Healthcare Utilization
timeFrame: 3-Months
measure: Change in Patient Well-Being
timeFrame: 3-Months
measure: Change in Patient Global Impression Change
timeFrame: 3-Months
Other outcomes:
measure: Change in Pain Intensity
timeFrame: 2-Months
measure: Change in Pain Interference
timeFrame: 2-Months
measure: Change in Drug Adverse Levels
timeFrame: 2-Months
measure: Change in Oral Opioid Intake
timeFrame: 2-Months
measure: Change in Patient Well-Being
timeFrame: 2-Months
measure: Change in Patient Global Impression Change
timeFrame: 2-Months
measure: Change in Pain Intensity
timeFrame: 1-Month
measure: Change in Pain Interference
timeFrame: 1-Month
measure: Change in Drug Adverse Levels
timeFrame: 1-Month
measure: Change in Oral Opioid Intake
timeFrame: 1-Month
measure: Change in Patient Well-Being
timeFrame: 1-Month
measure: Change in Patient Global Impression Change
timeFrame: 1-Month
measure: Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI)
timeFrame: 6-Months
measure: Average change from baseline to 6-Months in oral opioid intake
timeFrame: 6-Months
measure: 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
timeFrame: 6-Months
measure: Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire
timeFrame: 6-Months
measure: Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire
timeFrame: 6-Months
Locations:
city: Oshkosh
country: United States
facility: Advocate Aurora Health
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mansoor M Aman, MD
role: PRINCIPAL_INVESTIGATOR
References: