Chemotherapy-induced Peripheral NeuropathyNCT06389721
Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Electroencephalogram (EEG)
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants at MD Anderson Cancer Center
Who may be able to join
- 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.
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- 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.
Who cannot join
- Objective 1 Exclusion criteria:
- Participants who are taking any antipsychotic medications.
- With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
- Have ever been diagnosed with bipolar disorder or schizophrenia.
- Known, previously diagnosed peripheral neuropathy from any causes and
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Prinsloo, PHD, 713-745-4260, lcohen@mdanderson.org
Lorenzo Cohen, PHD
About this study
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.
Read the 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.
- Being tested
- Electroencephalogram (EEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG)Diagnostic test
Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - First 30 Participants | The first 30 participants make up Cohort 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). Receives: Diagnostic Test: Electroencephalogram (EEG) | |
| Cohort 2 - Participants 31-45 | Participants 31-45 make up Cohort 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. Receives: Diagnostic Test: Electroencephalogram (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start16 Jul 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389721
- Sponsor's protocol ID
- 2024-0145
- Other IDs
- NCI-2024-03672
- Status last verified
- May 2026
- First submitted
- 25 Apr 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06389721
- Acronym / sponsor ID
- 2024-0145
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - First 30 Participants | – | Diagnostic Test: Electroencephalogram (EEG)The first 30 participants make up Cohort 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 31-45 | – | Diagnostic Test: Electroencephalogram (EEG)Participants 31-45 make up Cohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at MD Anderson Cancer Center
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- Participants who are taking any antipsychotic medications.
- With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
- Have ever been diagnosed with bipolar disorder or schizophrenia.
- Known, previously diagnosed peripheral neuropathy from any causes and
- A history of head injury or who have known seizure activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroencephalogram (EEG)Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements. | Diagnostic test | Cohort 1 - First 30 Participants, Cohort 2 - Participants 31-45 |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
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Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Cohen, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Cohen, PHD ((713) 745-4260, lcohen@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.