Chemotherapy-induced Peripheral Neuropathy
Conditions
Brief summary
Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN). Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN.
Detailed description
Primary Objectives: Objective 1 (Primary Objective): to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment. Secondary Objectives: Objective 2 (Secondary Objective): To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy. Exploratory Objective: Explore whether there are associations between change in brain function and subjective report of CIPN.
Interventions
DIAGNOSTIC_TESTElectroencephalogram (EEG)
Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Objective 1 Inclusion criteria 1. Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements. 2. ECOG Performance Status of 0-2; 3. Willing to come to MD Anderson for the imaging sessions. 4. Are 18 years of age or above. 5. Have a diagnosis of breast cancer. 6. will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel; Objective 2 Inclusion criteria: 1\) Inclusion criteria: Identical to Objective 1 and are willing to participate in the therapy sessions at their homes.
Exclusion criteria
Objective 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs) | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
Primary ContactSarah Prinsloo, PHD
Outcome results
None listed