Cordotomy in Reducing Pain in Patients With Advanced Cancer

Percutaneous Cordotomy for Pain Palliation in 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Cordotomy; Drug: Morphine; Procedure: Sham Intervention

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 Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Bruera; Phone Number: 713-792-6084; Email: ebruera@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Eduardo Bruera; Phone Number: 713-792-6084
      • Principal Investigator: Eduardo Bruera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (cordotomy); Patients undergo a cordotomy over 1-2 hours.	Other: Questionnaire Administration; Ancillary studies; Procedure: Cordotomy; Undergo cordotomy
Sham Comparator: Group II (morphine, fake cordotomy); Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.	Other: Questionnaire Administration; Ancillary studies; Drug: Morphine; Given via injection; Procedure: Sham Intervention; Undergo fake cordotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in pain intensity	Will be measured by the Edmonton Symptom Assessment Scale (ESAS).	Up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Eduardo Bruera, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 2019-0264 (Other Identifier: M D Anderson Cancer Center); NCI-2019-03708 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01NR018481 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No