Evaluating targeted drug delivery for cancer pain management
Intrathecal Targeted Drug Delivery for Cancer Associated Pain
This study is testing if using targeted drug delivery along with regular pain management helps people with cancer pain feel better compared to just using regular treatment alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 169 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Oshkosh, Wisconsin) |
| Trial ID | NCT05674240 on ClinicalTrials.gov |
What this trial studies
This observational registry study aims to compare treatment outcomes between patients with cancer-associated pain receiving conservative medical management and those receiving intrathecal targeted drug delivery in addition to conservative management. Up to 169 subjects will be enrolled and followed for up to 3 months, with evaluations conducted monthly to assess pain intensity, medication use, quality of life, and healthcare utilization. The study will also track any adverse effects related to opioid use in both groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with uncontrolled cancer-associated pain despite high doses of oral opioids.
Not a fit: Patients with controlled pain or those experiencing adverse side effects that do not significantly affect their daily function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pain management strategy for patients suffering from cancer-associated pain.
How similar studies have performed: Other studies have shown promise in using targeted drug delivery for pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Oshkosh, Wisconsin
- Advocate Aurora Health — Oshkosh, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Mansoor M Aman, MD — Wake Forest University Health Sciences
- Study coordinator: Mansoor M Aman, MD
- Email: mansoor.aman@aah.org
- Phone: 9204564030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.