Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04119037

Cordotomy in Reducing Pain in Patients With Advanced Cancer

Percutaneous Cordotomy for Pain Palliation in Advanced Cancer

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. This study is being done to learn if a cordotomy reduces pain in patients with unmanageable cancer pain.

Detailed description

PRIMARY OBJECTIVES: I. Assess the efficacy of cordotomy for patients with unilateral advanced cancer pain. SECONDARY OBJECTIVES: I. Define the patient experience of cordotomy for cancer pain refractory to palliative care. II. Determine whether magnetic resonance imaging (MRI) can be used as a noninvasive biomarker for a successful cordotomy. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo a cordotomy over 1-2 hours. GROUP II: Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours. After completion of study, patients are followed up at 2 weeks and once every month for up to 6 months.

Conditions

Interventions

TypeNameDescription
PROCEDURECordotomyUndergo cordotomy
DRUGMorphineGiven via injection
OTHERQuestionnaire AdministrationAncillary studies
PROCEDURESham InterventionUndergo fake cordotomy

Timeline

Start date
2019-09-16
Primary completion
2028-12-01
Completion
2028-12-01
First posted
2019-10-08
Last updated
2026-03-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04119037. Inclusion in this directory is not an endorsement.