Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Sarah Prinsloo, PHD
sprinsloo@mdanderson.org
(713) 563-9627
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 45
Treatments
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).
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov