Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy

Baseline Tests:

If you agree to take part in this study, you will have the following baseline tests:

- You will complete 7 questionnaires about your symptoms, how you have been feeling, and
your general quality of life. It should take about 20 minutes to complete.

- Basic information about you (such as your age and education level) will also be
collected.

- You will have an EEG to measure the electrical activity of your brain. During the EEG,
researchers will place a cap containing 19 electrodes on your scalp and 1 electrode on
each earlobe. The electrodes will measure and record your brain wave activity, similar
to the way a doctor listens to your heart beat from the surface of your skin. The EEG
should take about 45 minutes to complete.

Study Groups:

After completing the baseline tests, you will be randomly assigned (as in the roll of a dice)
to 1 of 3 study groups. This is done because no one knows if one study group is better, the
same, or worse than the other group.

- If you are assigned to Group 1, you will receive traditional neurofeedback training.
Traditional neurofeedback training rewards you based on your own brain's activity.

- If you are assigned to Group 2, you will receive sham neurofeedback training. Sham
neurofeedback training does not use your own brainwaves. In sham neurofeedback, you will
be training from the brainwaves of another person who does not have neuropathy. Sham
neurofeedback is not designed to help train your brainwaves. It is designed to be
compared with traditional neurofeedback to learn if traditional neurofeedback has any
real effect. If you have any questions about how sham neurofeedback is designed to work,
talk with the study doctor or study staff.

- If you are assigned to Group 3, you will continue to receive standard care. You will not
take part in the neurofeedback training, but you will take part in the follow-up visits
(described below).

If you are assigned to Groups 1 or 2, you will not be told if you are receiving traditional
neurofeedback training or sham training.

Neurofeedback Training (Groups 1 and 2):

You will have at least 2 neurofeedback training sessions each week for up to 10 weeks (20
training sessions total). The training sessions may take place on any 2 days of the week and
may be up to 5 times a week, if you are interested in training more quickly. The study doctor
will discuss the option of training faster with you.

Each neurofeedback training session should take about 1 hour to complete.

During each session, you will have an EEG while you sit quietly, relax, and watch a computer
screen. The screen will be blank at first and then a series of pictures will appear. The
pictures will change as your brainwaves change. You may also be shown pictures of flowers,
bridges, mountains, and so on. You may be asked to play small games, for example a Pac-Man
type game in which a small character moves around a maze. You will be able to choose to
either view pictures or play a game.

When researchers see that your brain waves change in the way they are looking for, you will
be "rewarded." When you are rewarded you will see a pretty picture on screen and you will
hear a beep.

A neurotherapist will be present during each session to make sure you do not fall asleep and
that you are relaxed during the procedure.

At each neurofeedback training session, you will also be asked to rate your neuropathic
symptoms on a scale of 0-10 before you begin the neurofeedback training and again after the
session is complete. This should only take a few minutes.

Length of Participation:

Your active participation on this study will be over after follow-up. If you are in Groups 2
or 3, you may be able to stay on study for an additional 4 months if you agree to Optional
Procedure #1 (described below).

Follow-Up (All groups):

Within 1 week after your last neurofeedback training session and again about 1 month later:

- You will fill out the same 7 questionnaires you completed at baseline.

- You will have an EEG. If you are in Group 3, you will have this EEG about 1 week after
Group 1 has completed their neurofeedback training.

- After you have completed the assessment 1 month later, you will be told which group you
were in and offered neurofeedback if you were in the sham group.

Inclusion Criteria:

1. Patients must have the ability to understand and read English, sign a written informed
consent, and be willing to follow protocol requirements.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

3. Pain score >/= 4 on a 0-10 numeric pain scale and/or grade 3 neuropathic symptoms
according to the National Cancer Institute's 4 point grading scale.

4. Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating
physician).

5. Patients must report neuropathic pain for a minimum of 3 months.

6. No plans to change pain medication regimen during the course of the study.

7. Off active chemotherapy treatment for minimum of 6 months.

8. Willing to come to MD Anderson for the therapy sessions; or willing to participate in
the therapy sessions at their homes and live within a 45 minute drive of MDA main
campus; or can participate in the therapy sessions from one of MDA's Regional Care
Centers.

9. Patients who are 18 years of age or above

10. Patients who have a diagnosis of breast cancer.

Exclusion Criteria:

1. Patients who are taking any antipsychotic medications.

2. Patients with active central nervous system (CNS) disease, such as clinically-evident
metastases or leptomeningeal disease, dementia, or encephalopathy.

3. Patients who have ever been diagnosed with bipolar disorder or schizophrenia.

4. Patients with known, previously diagnosed peripheral neuropathy from causes other than
chemotherapy.

5. Patients who have a history of head injury or who have known seizure activity.