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Procedure
Cordotomy for Cancer Pain Management
N/A
Recruiting
Led By Eduardo Bruera
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)
Has undergone 3 palliative care evaluations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial is studying how well cordotomy works in reducing pain for patients with advanced cancer. Cordotomy is a procedure where a needle is used to target the spinal cord, guided by CT scans. The study is being done to see if cordotomy can help reduce pain for patients with cancer who can't manage their pain.
Who is the study for?
This trial is for advanced cancer patients with pain intensity of 4 or higher on a scale of 0-10, specifically below the shoulder level. Participants must have had three palliative care evaluations and be able to consent. Those who can't complete forms, have less than a month to live, issues with blood clotting, sedation risks, brain tumors or morphine allergies cannot join.Check my eligibility
What is being tested?
The study tests if cordotomy—a needle procedure on the spinal cord guided by CT scans—can reduce severe cancer-related pain better than standard treatments like morphine. Patients will also answer questionnaires about their pain levels.See study design
What are the potential side effects?
Cordotomy may cause discomfort at the injection site, potential nerve damage leading to weakness or numbness, and risks associated with sedation. Morphine's side effects include drowsiness, constipation, nausea and potential dependency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cancer-related pain in one side of my body below the shoulder.
Select...
I have had three evaluations for symptom management and support.
Select...
My pain level is 4 or higher on a scale of 0 to 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in pain intensity
Secondary outcome measures
Brief Pain Inventory pain interference items
Other ESAS symptoms
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (cordotomy)Experimental Treatment2 Interventions
Patients undergo a cordotomy over 1-2 hours.
Group II: Group II (morphine, fake cordotomy)Placebo Group3 Interventions
Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cordotomy
2015
N/A
~20
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,519 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,963 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer-related pain in one side of my body below the shoulder.I have a blood clotting disorder that cannot be corrected.I have a large brain tumor.I cannot have medicines that make me sleep through an IV.I have had three evaluations for symptom management and support.Your doctor thinks you may not survive for more than a month.My pain level is 4 or higher on a scale of 0 to 10.You are allergic to morphine.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (morphine, fake cordotomy)
- Group 2: Group I (cordotomy)
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any historical cases of Cordotomy being used in clinical studies?
"Presently, 54 studies related to Cordotomy are being conducted globally. Of those trials, 15 have reached the third phase of testing. Although most experiments take place in Boston, MA., clinical sites across 131 locations are working on this intervention."
Answered by AI
Are there any available slots in this research trial for volunteers?
"Affirmative. According to the clinicaltrials.gov portal, this medical investigation is currently recruiting patients and was first published on September 16th 2019. The study requires 42 participants from a single location for successful completion."
Answered by AI
How many volunteers have been recruited for this clinical trial?
"Correct. According to the information hosted on clinicaltrials.gov, this medical research is currently in search of 42 participants from 1 recruitment centre and was initially posted on September 16th 2019 before being updated most recently on December 5th 2022."
Answered by AI
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