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

Neuropathy;Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121232
• Other study ID #: 2023-0301
• Secondary ID: NCI-2023-09269
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Saba Javed, M D
• Phone: (713) 792-9530
• Email: sjaved[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Device:
• 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.

Other:
• Control Group
Participants will not receive any intervention

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Foundation for Anesthesia Education and Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   M D Anderson Cancer Center