Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06389721

Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Lorenzo Cohen, PHD

PRINCIPAL_INVESTIGATOR

Sarah Prinsloo, PHD

CONTACT

[email protected]

713-745-4260

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Safety and adverse events (AEs)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Cohen, PHD

CONTACT

[email protected]

(713) 745-4260

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.