Cordotomy for Refractory Cancer Pain
Minimally Invasive Cordotomy for Refractory Cancer Pain
2 other identifiers
interventional
18
1 country
1
Brief Summary
The goal of this clinical research study is to learn if a cordotomy reduces pain in patients with unmanageable cancer pain. A cordotomy is a procedure, guided by computed tomography (CT) scans, that is performed on the spinal cord and is designed to reduce pain transmission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2020
CompletedJune 7, 2023
June 1, 2023
5 years
January 20, 2015
June 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain Intensity using a 0-10 numeric rating scale
The response rate for both the cordotomy and control groups determined by the change in pain intensity between day 1 and day 8. Pain intensity assessed before and after cordotomy using a 0-10 numeric rating scale. Response rate defined as a 33% reduction in pain intensity with a 95% confidence interval, separately within each arm.
Day 1 and Day 8
Study Arms (2)
Cordotomy Group
EXPERIMENTALRadiologist performs a spinal tap to inject a contrast drug into the spinal fluid. A 20G spinal needle guided by real-time CT scan to the C1-C2 level opposite to participant's pain. A radiofrequency electrode inserted through the spinal needle into the spinal cord, to the anatomic location of the spinothalamic tract. Once ideal position of the electrode is confirmed, 1 or 2 radiofrequency ablations performed at 70C-80C for 60 seconds. The procedure will take 1-2 hours. Quantitative sensory testing on day prior to procedure, and on postoperative days number 1 and 7. Pain and symptom questionnaire completed at baseline, over the phone during the first week of study, and at each follow up visit/phone call. Participants undergo quantitative sensory testing on day prior to procedure, and on postoperative days number 1 and 7. Sensory testing to include sharpness and heat detection.
Comprehensive Medical Management Group
ACTIVE COMPARATORParticipants receive best supportive care for 1 week. Depending on pain level after the first week, they may have a cordotomy at that time. Pain and symptom questionnaire completed at baseline, over the phone during the first week of study, and at each follow up visit/phone call.
Interventions
Radiologist performs a spinal tap to inject a contrast drug into the spinal fluid. A 20G spinal needle guided by real-time CT scan to the C1-C2 level opposite to participant's pain. A radiofrequency electrode inserted through the spinal needle into the spinal cord, to the anatomic location of the spinothalamic tract. Once ideal position of the electrode is confirmed, 1 or 2 radiofrequency ablations performed at 70C-80C for 60 seconds. The procedure will take 1-2 hours.
Pain and symptom questionnaire completed at baseline, by phone during first week of study, and once each month by phone during 6 month follow up.
Sharpness detection determined using 8, 10, 16, 20, 32, 64, and 128g weighted needle devices. Each stimulus applied for about 1 second in ascending order. Participants asked to rate each stimulus as producing the sensation of touch, pressure, sharp, or pain. The sharpness detection threshold defined as the mean force of the stimuli deemed ''sharp'' or ''painful'' from 3 trials separated by an average interval of 30 to 90 seconds.
Thermal ramps will applied using a 3.6 x 3.6 cm Peltier thermode (Medoc Inc.) from a baseline temperature set at 32C. Skin heated at a rate of 0.30C/s, and participants asked to signal when the stimulus is perceived as first becoming warmer and then painfully hot.
Eligibility Criteria
You may qualify if:
- Patients with one-sided, somatic pain due to tumor involvement below the shoulder level (C5 dermatome).
- Patients with refractory cancer pain who are seen by the Supportive Care or Pain Medicine teams, and who either (1) are on appropriate opioid therapy at the time of consultation, or (2) who undergo an initial consultation and at least 2 clinical follow-up evaluations by these services.
- Patients with a life expectancy greater than 1 month.
- Patients must be 18 years old or older.
- Patients must be able to read, speak and understand English or Spanish.
You may not qualify if:
- \) Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- American Cancer Society, Inc.collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashwin Viswanathan, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 26, 2015
Study Start
March 10, 2015
Primary Completion
February 25, 2020
Study Completion
February 25, 2020
Last Updated
June 7, 2023
Record last verified: 2023-06