Cordotomy in Reducing Pain in Patients With Advanced Cancer

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Advanced Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Procedure: Cordotomy; Procedure: Sham Intervention; Drug: Morphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04119037

2019-0264 (Other Identifier)

NCI-2019-03708 (Registry Identifier)

R01NR018481 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Group I (cordotomy)

Experimental group

Description:

Patients undergo a cordotomy over 1-2 hours.

Treatment:

Other: Questionnaire Administration

Procedure: Cordotomy

Group II (morphine, fake cordotomy)

Sham Comparator group

Description:

Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.

Treatment:

Drug: Morphine

Procedure: Sham Intervention

Other: Questionnaire Administration