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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
27
M D Anderson Cancer Center
Houston, Texas, United States
Reduction in pain intensity
Will be measured by the Edmonton Symptom Assessment Scale (ESAS).
Time frame: Up to 6 months
Brief Pain Inventory pain interference items
Will provide initial estimates of the magnitude of the effect of cordotomy.
Time frame: Up to 6 months
Other ESAS symptoms
Will provide initial estimates of the magnitude of the effect of cordotomy.
Time frame: Up to 6 months
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Undergo fake cordotomy