Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT03219502
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03219502
Study Brief:
Protocol Section:
NCT03219502