Cordotomy for Refractory Cancer Pain

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.

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).