Cordotomy in Reducing Pain in Patients With Advanced Cancer

Percutaneous Cordotomy for Pain Palliation in Advanced Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04119037

Enrollment

Registered

2019-10-08

Start date

2019-09-16

Completion date

2028-12-01

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignant Neoplasm

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.

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.

Interventions

PROCEDURECordotomy

Undergo cordotomy

DRUGMorphine

Given via injection

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESham Intervention

Undergo fake cordotomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREduardo Bruera

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026