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Cordotomy in Reducing Pain in Patients With Advanced Cancer

Cordotomy in Reducing Pain in Patients With Advanced Cancer

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Study details
    Advanced Malignant Neoplasm

NCT04119037

M.D. Anderson Cancer Center

20 August 2025

FAQs

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