Cordotomy in Reducing Pain in Patients With Advanced Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percutaneous Cordotomy for Pain Palliation in Advanced Cancer

Conditions
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Advanced Malignant Neoplasm

Intervention / Treatment
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* Procedure: Cordotomy
* Drug: Morphine
* Other: Questionnaire Administration
* Procedure: Sham Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |