rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy

PRIMARY OBJECTIVES:

I. Examine the effects of the repetitive transcranial magnetic stimulation (rTMS) training
program on perceptions of chemotherapy-induced peripheral neuropathy (CIPN) versus placebo
(PC) and wait-list control groups (WLC).

SECONDARY OBJECTIVES:

I. Explore changes in cortical activity: Electroencephalography (EEG) brain maps (low
resolution electromagnetic tomography) will be assessed over time and compared between
groups.

II. Determine if rTMS improves other aspects of CIPN, quality of life (QOL), and mental
health (MH) compared to PC and WLC.

III. Explore moderators/mediators of the intervention by examining the extent to which
changes in EEG patterns mediate the effects of the intervention and the extent to which there
are interaction effects of the intervention and each of the baseline brain regions.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.

GROUP II: Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.

GROUP III: Patients receive standard of care.

After completion of study, patients are followed up within 1 week and at 1 month.

Inclusion Criteria:

- Patients with stage I-IV cancers who received oxaliplatin chemotherapy

- Understand and read English, sign a written informed consent, and be willing to follow
protocol requirements

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

- Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4
point grading scale

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

- Patients must have neuropathic symptoms for a minimum of 3 months

- No plans to change the type of pain medication (if a patient is on pain medication)

- Willing to come to MD Anderson for the therapy sessions

Exclusion Criteria:

- Patients who are taking any antipsychotic medications

- Patients who have evidence of brain metastases or any with any active central nervous
system (CNS) disease at their time of entry into the trial

- Patients who have ever been diagnosed with bipolar disorder or schizophrenia

- Patients who have a history of head injury, focal brain lesions, or known seizure
activity

- Patients who are withdrawing from drugs

- Patients with intracranial implants or a cardiac pacemaker or any device that is not
considered magnetic resonance imaging (MRI) safe. Colorectal patients are sometimes
prescribed Tramadol to help control the symptoms of CIPN. Tramadol does lower the
seizure threshold, however these patients will be considered eligible for the study if
they discontinue the drug 48 hours before the baseline and do not use it during the
duration of the study