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Clinical Trials/NCT06121232
NCT06121232
Active, Not Recruiting
N/A

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

M.D. Anderson Cancer Center1 site in 1 country24 target enrollmentNovember 2, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neuropathy;Peripheral
Sponsor
M.D. Anderson Cancer Center
Enrollment
24
Locations
1
Primary Endpoint
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Status
Active, Not Recruiting
Last Updated
5 months ago

Overview

Brief Summary

To learn if a process called neuromodulation can help to improve pain due to CIP

Detailed Description

Inclusion Criteria: * 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

Registry
clinicaltrials.gov
Start Date
November 2, 2023
End Date
April 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time Frame: through study completion; an average of 1 year.

Study Sites (1)

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