Status:
WITHDRAWN
Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial studies how well a home-based neurofeedback program works in treating participants with chemotherapy-induced peripheral neuropathy (nerve damage that affects motor function). Neurofeedback ...
Detailed Description
PRIMARY OBJECTIVES: I. Examine the feasibility of using a home-based neurofeedback system and dry electroencephalography (EEG) cap to treat chemotherapy-induced peripheral neuropathy (CIPN). SECONDA...
Eligibility Criteria
Inclusion
- Patients must have the ability to 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.
- Neuropathic pain score \>= 4 on a 0-10 numeric pain scale (numeric rating scale \[NRS\]) and/or grade 3 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 had neuropathic symptoms for a minimum of 3 months.
- No plans to change pain medication regimen during the course of the study.
- Off active chemotherapy treatment for minimum of 6 months.
- 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.
- Willing to come to MD Anderson for the intake and follow up data acquisition and to receive their equipment.
- Willing to allow research staff to come to their homes or to return the equipment to MD Anderson (MDA) in the case of equipment malfunction.
- Have had a diagnosis of cancer treated with chemotherapy.
- Live within a 50 mile radius of MD Anderson's main campus.
Exclusion
- Patients who are taking any antipsychotic medications.
- Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.
- Patients who have ever been diagnosed with bipolar disorder or schizophrenia.
- Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
- Patients who have a history of head injury or who have known seizure activity.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03436680
Start Date
September 1 2020
End Date
December 31 2021
Last Update
March 4 2022
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