Cordotomy in Reducing Pain in Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT04119037 |
Recruitment Status :
Recruiting
First Posted : October 8, 2019
Last Update Posted : December 17, 2019
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Tracking Information | |||||
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First Submitted Date ICMJE | September 11, 2019 | ||||
First Posted Date ICMJE | October 8, 2019 | ||||
Last Update Posted Date | December 17, 2019 | ||||
Actual Study Start Date ICMJE | September 16, 2019 | ||||
Estimated Primary Completion Date | September 30, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Reduction in pain intensity [ Time Frame: Up to 6 months ] Will be measured by the Edmonton Symptom Assessment Scale (ESAS).
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Original Primary Outcome Measures ICMJE |
Reduction in pain intensity: Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: Up to 6 months ] ESAS consists of 10 symptom items to measure severity of participants symptoms. Grading severity of symptoms from "no" 0 to "worst symptom" 10.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cordotomy in Reducing Pain in Patients With Advanced Cancer | ||||
Official Title ICMJE | Percutaneous Cordotomy for Pain Palliation in Advanced Cancer | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Supportive Care |
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Condition ICMJE | Advanced Malignant Neoplasm | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
42 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 30, 2024 | ||||
Estimated Primary Completion Date | September 30, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04119037 | ||||
Other Study ID Numbers ICMJE | 2019-0264 NCI-2019-03708 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2019-0264 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) R01NR018481 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |