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
NCT ID: NCT06121232
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
24 participants
INTERVENTIONAL
2023-11-02
2026-04-01
Brief Summary
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Detailed Description
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* 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
Exclusion Criteria:
* 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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Group 1 will receive neuromodulation.
Abbott® DRG / Abbott®/Medtronic® SCS
Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.
Control Group
Group 2 will not receive neuromodulation.
Control Group
Participants will not receive any intervention
Interventions
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Abbott® DRG / Abbott®/Medtronic® SCS
Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.
Control Group
Participants will not receive any intervention
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Foundation for Anesthesia Education and Research
OTHER
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Saba Javed, M D
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2023-09269
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0301
Identifier Type: -
Identifier Source: org_study_id
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