Cordotomy in Reducing Pain in Patients With Advanced Cancer

Not Applicable

Active, not recruiting

• Conditions: Advanced Malignant Neoplasm
• Interventions: Procedure: Cordotomy; Drug: Morphine; Other: Questionnaire Administration; Procedure: Sham Intervention

• Registration Number: NCT04119037
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-11
• Study Start: 2019-09-16
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Ability to provide informed consent
• Has undergone 3 palliative care evaluations
• Pain intensity >= 4 on a 0-10 numerical scale
• Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)

Exclusion Criteria

• Uncorrectable coagulopathy
• Large intracranial mass
• Inability to complete assessment forms
• Life expectancy < 1 month
• Contraindication to intravenous sedation
• Morphine allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (morphine, fake cordotomy)	Questionnaire Administration	Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
Group I (cordotomy)	Cordotomy	Patients undergo a cordotomy over 1-2 hours.
Group I (cordotomy)	Questionnaire Administration	Patients undergo a cordotomy over 1-2 hours.
Group II (morphine, fake cordotomy)	Sham Intervention	Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
Group II (morphine, fake cordotomy)	Morphine	Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.

Primary Outcome Measures

Name	Time	Method
Reduction in pain intensity	Up to 6 months	Will be measured by the Edmonton Symptom Assessment Scale (ESAS).

Secondary Outcome Measures

Name	Time	Method
Other ESAS symptoms	Up to 6 months	Will provide initial estimates of the magnitude of the effect of cordotomy.
Brief Pain Inventory pain interference items	Up to 6 months	Will provide initial estimates of the magnitude of the effect of cordotomy.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States