Clinical trial NCT02345629: Cordotomy for Refractory Cancer Pain
Official title: Minimally Invasive Cordotomy for Refractory Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancers
Pain
Keywords: Refractory cancer pain
Cordotomy
Sharpness pain sensory testing
Heat pain sensory testing
Symptom questionnaire
Advanced cancers
Pain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-01-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with one-sided, somatic pain due to tumor involvement below the shoulder level (C5 dermatome).
2. 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.
3. Patients with a life expectancy greater than 1 month.
4. Patients must be 18 years old or older.
5. Patients must be able to read, speak and understand English or Spanish.

Exclusion Criteria:

1) Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion).

Primary outcomes:
measure: Change in Pain Intensity using a 0-10 numeric rating scale
timeFrame: Day 1 and Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ashwin Viswanathan, MD
role: PRINCIPAL_INVESTIGATOR
References: