Clinical Trial Details
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NCT02573766 : Neuromodulation as a Treatment for Chemotherapy-Induced Peripheral Neuropathy
AgesMin: 18 Years Max: N/A
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

5. Patients must have had 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. Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.)
therapies allowed as long as they will be continued during the course of the study.

9. 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

10. Patients who are 18 years of age or above

11. 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.
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