Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

NCT06389721 | Recruiting

• 2 other identifiers: 2024-0145NCI-2024-03672
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (2)

Cohort 1

Participants in Group 1, you will have an EEG and complete one questionnaire prior to your first dose of chemotherapy and once monthly until the end of your chemotherapy (for a maximum of 6 measurements).

Diagnostic Test: Electroencephalogram (EEG)

Cohort 2

Participants in Group 2, you will have an EEG, and complete a questionnaire before and after your chemotherapy regimen. Participants will also have a treatment called closed-loop brain-computer interface (clBCI) training twice a week for the 2 weeks leading up to starting chemotherapy, and then twice a week during chemotherapy, for a maximum of 32 sessions, which you will be able to do at home.

Diagnostic Test: Electroencephalogram (EEG)

Interventions

Electroencephalogram (EEG) DIAGNOSTIC_TEST

Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants at MD Anderson Cancer Center

You may qualify if:

• 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;

You may not qualify if:

• 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 causes other than chemotherapy; and
• A history of head injury or who have known seizure activity, or with a prior history of chemotherapy.
• Patients who will be administered ddAC-\>T.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Lorenzo Cohen, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Cohen, PHD

CONTACT

(713) 745-4260; lcohen@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)