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Trial Title:
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain
NCT ID:
NCT05674240
Condition:
Cancer Pain
Chronic Pain
Cancer Associated Pain
Neuropathic Pain
Conditions: Official terms:
Neuralgia
Chronic Pain
Cancer Pain
Conditions: Keywords:
targeted drug delivery
cancer pain
conservative pain management
neuromodulation
opioid
healthcare-utilization
quality of life
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Intrathecal Targeted Drug Delivery
Description:
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to
the spinal cord.
Arm group label:
Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM
Other name:
Medtronic SynchroMed™ II pump
Intervention type:
Combination Product
Intervention name:
Conservative medical management
Description:
Including physical therapy, oral or transdermal medications and injections
Arm group label:
Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM
Arm group label:
Cancer associated pain treated with conservative medical management (CMM) only
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 months post-implant.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Advocate Aurora Health
Address:
City:
Oshkosh
Zip:
54904
Country:
United States
Status:
Recruiting
Contact:
Last name:
Merve B Figueira, MS
Phone:
920-456-1551
Email:
merve.figueira@aah.org
Investigator:
Last name:
Mansoor M Aman, MD
Email:
Principal Investigator
Investigator:
Last name:
Vishal M Patel, MD
Email:
Sub-Investigator
Start date:
December 6, 2022
Completion date:
December 6, 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674240
