Cordotomy in Reducing Pain in Patients With Advanced Cancer

Advanced Malignant Neoplasm Clinical Trial

Official title:

Percutaneous Cordotomy for Pain Palliation in Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04119037
• Other study ID #: 2019-0264
• Secondary ID: NCI-2019-0370820
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Eduardo Bruera
• Phone: 713-792-6084
• Email: ebruera[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Cordotomy
Undergo cordotomy

Drug:
• Morphine
Given via injection

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Sham Intervention
Undergo fake cordotomy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain intensity	Will be measured by the Edmonton Symptom Assessment Scale (ESAS).	Up to 6 months
Secondary	Brief Pain Inventory pain interference items	Will provide initial estimates of the magnitude of the effect of cordotomy.	Up to 6 months
Secondary	Other ESAS symptoms	Will provide initial estimates of the magnitude of the effect of cordotomy.	Up to 6 months

External Links

•   MD Anderson Cancer Center Website