Cordotomy in Reducing Pain in Patients With Advanced Cancer

NCT04119037 | Active Not Recruiting DMC

• 3 other identifiers: 2019-0264NCI-2019-03708R01NR018481
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Reduction in pain intensity

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

  Up to 6 months

Secondary Outcomes (2)

• Brief Pain Inventory pain interference items

  Up to 6 months

• Other ESAS symptoms

  Up to 6 months

Study Arms (2)

Group I (cordotomy)

EXPERIMENTAL

Patients undergo a cordotomy over 1-2 hours.

Procedure: Cordotomy; Other: Questionnaire Administration

Group II (morphine, fake cordotomy)

SHAM COMPARATOR

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

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

Interventions

Cordotomy PROCEDURE

Undergo cordotomy

Group I (cordotomy)

Morphine DRUG

Given via injection

Group II (morphine, fake cordotomy)

Sham Intervention PROCEDURE

Undergo fake cordotomy

Group II (morphine, fake cordotomy)

Questionnaire Administration OTHER

Ancillary studies

Group I (cordotomy); Group II (morphine, fake cordotomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Uncorrectable coagulopathy
• Large intracranial mass
• Inability to complete assessment forms
• Life expectancy \< 1 month
• Contraindication to intravenous sedation
• Morphine allergy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Cordotomy; Morphine

Intervention Hierarchy (Ancestors)

Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Eduardo Bruera

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 8, 2019
• Study Start: September 16, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)