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Search / Trial NCT05674240

Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Dec 21, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Targeted Drug Delivery Cancer Pain Conservative Pain Management Neuromodulation Opioid Healthcare Utilization Quality Of Life

ClinConnect Summary

This clinical trial is studying a new approach to help manage cancer-related pain. The researchers want to find out how well a targeted drug delivery system works compared to traditional medication management. Specifically, they will look at how much pain patients feel, how their pain affects their daily activities, and if they need to use other medicines or if they experience side effects from opioids (painkillers). By comparing these two methods, the goal is to see if one is more effective in improving patients' quality of life.

To participate in this study, individuals must be at least 21 years old and have uncontrolled cancer pain that is not relieved by standard oral pain medications. They should also be experiencing negative side effects from long-term use of opioids that affect their daily life. Participants can expect to be closely monitored throughout the trial, and their experiences will help researchers understand the best ways to manage cancer pain for future patients. This trial is currently recruiting participants of all genders and is designed for those who have a life expectancy of more than three months.

Gender

ALL

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)

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Oshkosh, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Mansoor M Aman, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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