Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
2 other identifiers
interventional
24
1 country
1
Brief Summary
To learn if a process called neuromodulation can help to improve pain due to CIP
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedStudy Start
First participant enrolled
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedNovember 17, 2025
November 1, 2025
2.4 years
October 25, 2023
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
through study completion; an average of 1 year.
Study Arms (2)
Treatment Group
EXPERIMENTALGroup 1 will receive neuromodulation.
Control Group
EXPERIMENTALGroup 2 will not receive neuromodulation.
Interventions
Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.
Eligibility Criteria
You may qualify if:
- Ability to understand and the willingness to sign a written informed consent document
- Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
- Patients seen at Pain Management Center at MD Anderson Cancer Center
- Patient ages greater or equal to 18 years but less than or equal to 85 years
You may not qualify if:
- Patients with cognitive dysfunction
- Patient with recent history (\<6 months) of drug or alcohol abuse
- Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saba Javed, M D
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
November 7, 2023
Study Start
November 2, 2023
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
November 17, 2025
Record last verified: 2025-11