Chronic Pain Clinical Trial
Official title:
Intrathecal Targeted Drug Delivery for Cancer Associated Pain
NCT number | NCT05674240 |
Other study ID # | 22-820 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 6, 2022 |
Est. completion date | December 6, 2025 |
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.
Status | Recruiting |
Enrollment | 169 |
Est. completion date | December 6, 2025 |
Est. primary completion date | June 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Advocate Aurora Health | Oshkosh | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Mansoor Aman, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Change in Oral Opioid Intake | Average change from baseline to 2-Months in oral opioid intake | 2-Months | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Change in Oral Opioid Intake | Average change from baseline to 1-Month in oral opioid intake | 1-Month | |
Other | 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 | |
Other | 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 | |
Other | Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI) | 6-Months | ||
Other | Average change from baseline to 6-Months in oral opioid intake | 6-Months | ||
Other | 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 | ||
Other | Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire | 6-Months | ||
Other | Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire | 6-Months | ||
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Change in Oral Opioid Intake | Average change from baseline to 3-Months in oral opioid intake | 3-Months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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