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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06121232

Collaborator

Foundation for Anesthesia Education and Research (Other)

Enrollment

Location

Arms

28.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neuropathy;Peripheral	Device: Abbott® DRG / Abbott®/Medtronic® SCS Other: Control Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Group 1 will receive neuromodulation.	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.
Experimental: Control Group Group 2 will not receive neuromodulation.	Other: Control Group Participants will not receive any intervention

Arm

Intervention/Treatment

Experimental: Treatment Group

Group 1 will receive neuromodulation.

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.

Experimental: Control Group

Group 2 will not receive neuromodulation.

Other: Control Group

Participants will not receive any intervention

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

Principal Investigator: Saba Javed, M D, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

M D Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT06121232

Other Study ID Numbers:

2023-0301
NCI-2023-09269

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Nov 7, 2023