Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroencephalogram (EEG).
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Electroencephalogram (EEG)
Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.
Primary outcome measures
- Safety and adverse events (AEs) [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
Inclusion criteria
Objective 1 Inclusion criteria
- Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
- ECOG Performance Status of 0-2;
- Willing to come to MD Anderson for the imaging sessions.
- Are 18 years of age or above.
- Have a diagnosis of breast cancer.
- 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 Exclusion criteria:
- Participants who are taking any antipsychotic medications.
- With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
- Have ever been diagnosed with bipolar disorder or schizophrenia.
- Known, previously diagnosed peripheral neuropathy from any causes and
- A history of head injury or who have known seizure activity.
Objective 2 Exclusion criteria
1\) Same exclusion criteria as in Objective1. Medication usage will be tracked for patients in all groups. Once prescribed, participants must remain on a stable course of medications throughout the course of chemotherapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06389721 · 2024-0145 · NCI-2024-03672