Advanced CancersNCT02345629
Cordotomy for Refractory Cancer Pain
A study testing Cordotomy, Pain/Symptom Questionnaire and Sharpness Sensory Testing in people with Advanced Cancers and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Pain
- What is being tested?
- Cordotomy, Pain/Symptom Questionnaire and Sharpness Sensory Testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2015to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Minimally Invasive Cordotomy for Refractory Cancer Pain
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.
Read the detailed description
Baseline Tests:
If you agree to take part in this study, you will have the following tests and procedures:
- You will have a physical exam.
- You will complete 2 questionnaires that ask about any symptoms and pain you may be having. It should take about 10 minutes to complete the questionnaires.
- You will have sensory testing. These are tests to measure your level of pain and feelings of hot and cold in the foot, palm of the hand, and the area where your pain is the worst.
Study Groups:
You will be assigned to 1 of 2 groups. You will have an equal chance of being in either group.
- If you are in Group 1, you will have a cordotomy the day after the baseline tests.
- If you are in Group 2, you will receive the best supportive care for 1 week. Depending on your pain level after the first week, you may have a cordotomy at that time.
Cordotomy Procedure:
If you are in Group 2, you will have a physical exam on the day of the cordotomy.
The cordotomy procedure will take place in the CT scan area. Before the procedure, a radiologist will perform a spinal tap to inject a contrast drug into the spinal fluid. This will allow researchers to see the spinal cord well on the CT scan. You will be taken to the diagnostic CT scanner and given local anesthetic and standard drugs by vein to help you feel comfortable. A needle will be inserted using CT scan guidance into the side of the neck opposite to your pain. A radiofrequency electrode will pass through the needle into your spinal cord, and your nerve reactions to movement and sensation will be checked. If these reactions are not satisfactory, the needle will be adjusted or the procedure will be stopped.
Once the best position for the needle is found, the surgeon will use the radiofrequency electrode to heat the pain pathway in the spinal cord at that point, so that your sensation of pain is less. During this process, you will be checked for signs of weakness.
The procedure will take 1-2 hours. You will sign a separate consent form for this procedure.
One day to one week after the procedure, you will have a MRI to help determine the effect of the cordotomy on your spinal nerves.
Study Tests and Phone Calls:
All participants will return to the clinic or be seen in the hospital the day after the cordotomy and again 1 week later. At these visits, you will have a physical exam and sensory testing.
You will be called by phone 1 time during the first week of the study. You will be asked to complete the pain and symptom questionnaires over the phone. If you are not able to return to the clinic a week after your cordotomy, you will also be called at that time.
Follow-Up Calls:
You will return to the clinic or be called on the phone 1 time each month for as long as you are still having pain. You will be asked to complete the pain and symptom questionnaires.
Length of Study Participation:
You active participation in this study will be over 6 months after your cordotomy, if you have one.
This is an investigational study. It is investigational to perform a cordotomy to learn if the procedure reduces pain in patients with unmanageable cancer pain.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Pain
- Being tested
- Cordotomy, Pain/Symptom Questionnaire, Sharpness Sensory Testing, Heat Pain Sensory Testing
- Keywords
- Refractory cancer pain, Cordotomy, Sharpness pain sensory testing, Heat pain sensory testing, Symptom questionnaire, Advanced cancers, Pain
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CordotomyProcedure or surgery
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/Symptom QuestionnaireBehavioural
Also called Survey
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 Sensory TestingProcedure or surgery
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.
Heat Pain Sensory TestingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cordotomy Group | Experimental | 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. 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. Receives: Procedure: Cordotomy; Behavioral: Pain/Symptom Questionnaire; Procedure: Sharpness Sensory Testing; Procedure: Heat Pain Sensory Testing |
| Comprehensive Medical Management Group | Active comparator | Participants 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. Receives: Procedure: Cordotomy; Procedure: Sharpness Sensory Testing; Procedure: Heat Pain Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start10 Mar 2015
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashwin Viswanathan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345629
- Sponsor's protocol ID
- 2014-0833
- Other IDs
- NCI-2015-00206
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2015
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Cordotomy for Refractory Cancer Pain
- ClinicalTrials.gov ID
- NCT02345629
- Acronym / sponsor ID
- 2014-0833
- Conditions
- Advanced Cancers, Pain
- Keywords
- Refractory cancer pain, Cordotomy, Sharpness pain sensory testing, Heat pain sensory testing, Symptom questionnaire, Advanced cancers, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Baseline Tests:
If you agree to take part in this study, you will have the following tests and procedures:
- You will have a physical exam.
- You will complete 2 questionnaires that ask about any symptoms and pain you may be having. It should take about 10 minutes to complete the questionnaires.
- You will have sensory testing. These are tests to measure your level of pain and feelings of hot and cold in the foot, palm of the hand, and the area where your pain is the worst.
Study Groups:
You will be assigned to 1 of 2 groups. You will have an equal chance of being in either group.
- If you are in Group 1, you will have a cordotomy the day after the baseline tests.
- If you are in Group 2, you will receive the best supportive care for 1 week. Depending on your pain level after the first week, you may have a cordotomy at that time.
Cordotomy Procedure:
If you are in Group 2, you will have a physical exam on the day of the cordotomy.
The cordotomy procedure will take place in the CT scan area. Before the procedure, a radiologist will perform a spinal tap to inject a contrast drug into the spinal fluid. This will allow researchers to see the spinal cord well on the CT scan. You will be taken to the diagnostic CT scanner and given local anesthetic and standard drugs by vein to help you feel comfortable. A needle will be inserted using CT scan guidance into the side of the neck opposite to your pain. A radiofrequency electrode will pass through the needle into your spinal cord, and your nerve reactions to movement and sensation will be checked. If these reactions are not satisfactory, the needle will be adjusted or the procedure will be stopped.
Once the best position for the needle is found, the surgeon will use the radiofrequency electrode to heat the pain pathway in the spinal cord at that point, so that your sensation of pain is less. During this process, you will be checked for signs of weakness.
The procedure will take 1-2 hours. You will sign a separate consent form for this procedure.
One day to one week after the procedure, you will have a MRI to help determine the effect of the cordotomy on your spinal nerves.
Study Tests and Phone Calls:
All participants will return to the clinic or be seen in the hospital the day after the cordotomy and again 1 week later. At these visits, you will have a physical exam and sensory testing.
You will be called by phone 1 time during the first week of the study. You will be asked to complete the pain and symptom questionnaires over the phone. If you are not able to return to the clinic a week after your cordotomy, you will also be called at that time.
Follow-Up Calls:
You will return to the clinic or be called on the phone 1 time each month for as long as you are still having pain. You will be asked to complete the pain and symptom questionnaires.
Length of Study Participation:
You active participation in this study will be over 6 months after your cordotomy, if you have one.
This is an investigational study. It is investigational to perform a cordotomy to learn if the procedure reduces pain in patients with unmanageable cancer pain.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cordotomy Group | Experimental | Procedure: Cordotomy, Behavioral: Pain/Symptom Questionnaire, Procedure: Sharpness Sensory Testing, Procedure: Heat Pain Sensory TestingRadiologist 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 comparator | Procedure: Cordotomy, Procedure: Sharpness Sensory Testing, Procedure: Heat Pain Sensory TestingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CordotomyRadiologist 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. | Procedure or surgery | Comprehensive Medical Management Group, Cordotomy Group |
| Pain/Symptom QuestionnaireAlso: SurveyPain and symptom questionnaire completed at baseline, by phone during first week of study, and once each month by phone during 6 month follow up. | Behavioural | Cordotomy Group |
| Sharpness Sensory TestingSharpness 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. | Procedure or surgery | Comprehensive Medical Management Group, Cordotomy Group |
| Heat Pain Sensory TestingThermal 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. | Procedure or surgery | Comprehensive Medical Management Group, Cordotomy Group |
Primary outcome
Change in Pain Intensity using a 0-10 numeric rating scale
Time frame: Day 1 and Day 8
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashwin Viswanathan, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordotomy, Pain/Symptom Questionnaire and Sharpness Sensory Testing in people with Advanced Cancers and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity using a 0-10 numeric rating scale (time frame: Day 1 and Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.