Tracking and preventing nerve pain from chemotherapy

Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

This study is testing how to track and prevent nerve pain caused by chemotherapy in breast cancer patients by monitoring their brain activity and trying a new brain-computer interface to help reduce the pain.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide, doxorubicin
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06389721 on ClinicalTrials.gov

What this trial studies

This observational study aims to understand and prevent chemotherapy-induced peripheral neuropathy (CIPN) by tracking its onset and progression in patients undergoing chemotherapy for breast cancer. Participants will be monitored for changes in brain activity and CIPN symptoms using electrophysiological markers and electroencephalogram (EEG) assessments. Additionally, the study will evaluate the effectiveness of a closed-loop brain-computer interface (clBCI) in regulating brain function and potentially alleviating CIPN-related pain during treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of breast cancer who are scheduled to receive specific chemotherapy agents.

Not a fit: Patients with active central nervous system diseases or those taking antipsychotic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new methods for preventing or reducing nerve pain in patients receiving chemotherapy.

How similar studies have performed: While there is ongoing research in the area of CIPN, the use of a closed-loop brain-computer interface for this purpose is relatively novel and has not been extensively tested.

Eligibility criteria

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 Exclusion criteria:

1. Participants who are taking any antipsychotic medications.
2. With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
3. Have ever been diagnosed with bipolar disorder or schizophrenia.
4. Known, previously diagnosed peripheral neuropathy from causes other than chemotherapy; and
5. A history of head injury or who have known seizure activity, or with a prior history of chemotherapy.
6. Patients who will be administered ddAC-\>T.

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.

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Lorenzo Cohen, PHD — M.D. Anderson Cancer Center
• Study coordinator: Lorenzo Cohen, PHD

Conditions Chemotherapy-induced Peripheral Neuropathy