NCT06389721 Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
| NCT ID | NCT06389721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Chemotherapy-induced Peripheral Neuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-07-16 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2024-07-16 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 any causes and 5. A history of head injury or who have known seizure activity. 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.
Contact & Investigator
Lorenzo Cohen, PHD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06389721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389721 currently recruiting?
Yes, NCT06389721 is actively recruiting participants. Contact the research team at lcohen@mdanderson.org for enrollment information.
Where is the NCT06389721 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06389721 clinical trial?
NCT06389721 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Lorenzo Cohen, PHD at M.D. Anderson Cancer Center. The trial plans to enroll 45 participants.