RECRUITING

Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

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Conditions

Chemotherapy-induced Peripheral Neuropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Quick Facts

Study Start:2024-07-16
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06389721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
  2. 2. ECOG Performance Status of 0-2;
  3. 3. Willing to come to MD Anderson for the imaging sessions.
  4. 4. Are 18 years of age or above.
  5. 5. Have a diagnosis of breast cancer and who are scheduled to begin chemotherapy.
  6. 6. will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel; 7) participants scheduled to receive six months of chemotherapy.
  1. 1. Participants who are taking any antipsychotic medications.
  2. 2. With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
  3. 3. Have ever been diagnosed with bipolar disorder or schizophrenia.
  4. 4. Known, previously diagnosed peripheral neuropathy from causes other than chemotherapy; and
  5. 5. A history of head injury or who have known seizure activity, or with a prior history of chemotherapy.
  6. 6. Patients who will be administered ddAC-\>T.

Contacts and Locations

Study Contact

Sarah Prinsloo, PHD
CONTACT
(713) 563-9627
sprinsloo@mdanderson.org

Principal Investigator

Sarah Prinsloo, PHD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Sarah Prinsloo, PHD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-07-16
Study Completion Date2027-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chemotherapy-induced Peripheral Neuropathy