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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03708 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0264 | Other Identifier | M D Anderson Cancer Center | |
| R01NR018481 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (cordotomy) | Experimental | Patients undergo a cordotomy over 1-2 hours. |
|
| Group II (morphine, fake cordotomy) | Sham Comparator | Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordotomy | Procedure | Undergo cordotomy |
| |
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain intensity | Will be measured by the Edmonton Symptom Assessment Scale (ESAS). | Up to 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Bruera | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D002818 | Cordotomy |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D009022 | Morphine Derivatives |
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| Drug |
Given via injection |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Sham Intervention | Procedure | Undergo fake cordotomy |
|
| Up to 6 months |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |