Clinical trial NCT06389721: Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Official title: Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants at MD Anderson Cancer Center

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.

Detailed 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.

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.

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarah Prinsloo, PHD
role: PRINCIPAL_INVESTIGATOR
References: