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NCT Number: NCT04119037

Cordotomy in Reducing Pain in Patients With Advanced Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Malignant Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cordotomy

Procedure

Undergo cordotomy

Morphine

Drug

Given via injection

Questionnaire Administration

Other

Ancillary studies

sham intervention

Procedure

Undergo fake cordotomy

Primary outcomes

  1. Reduction in pain intensity

    Time frame: Up to 6 months

    Will be measured by the Edmonton Symptom Assessment Scale (ESAS).

Secondary outcomes

  1. Brief Pain Inventory pain interference items

    Time frame: Up to 6 months

    Will provide initial estimates of the magnitude of the effect of cordotomy.

  2. Other ESAS symptoms

    Time frame: Up to 6 months

    Will provide initial estimates of the magnitude of the effect of cordotomy.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Percutaneous Cordotomy for Pain Palliation in Advanced Cancer

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2019
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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