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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cordotomy | Undergo cordotomy |
| DRUG | Morphine | Given via injection |
| OTHER | Questionnaire Administration | Ancillary studies |
| PROCEDURE | Sham Intervention | Undergo 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.