Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389721
• Other study ID #: 2024-0145
• Secondary ID: NCI-2024-03672
• Status: Not yet recruiting
• Start date: October 31, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Sarah Prinsloo, PHD
• Phone: (713) 563-9627
• Email: sprinsloo[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 and who are scheduled to begin chemotherapy.

6. will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel; 7) participants scheduled to receive six months of chemotherapy.

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   MD Anderson Cancer Center