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

Not Applicable

Recruiting

• Conditions: Neuropathy;Peripheral
• Interventions: Device: Abbott® DRG / Abbott®/Medtronic® SCS; Other: Control Group

• Registration Number: NCT06121232
• Lead Sponsor: M.D. Anderson Cancer Center

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

Study Timeline

• Study First Submitted: 2023-10-25
• Study Start: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Abbott® DRG / Abbott®/Medtronic® SCS	Group 1 will receive neuromodulation.
Control Group	Control Group	Group 2 will not receive neuromodulation.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States