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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2026-04-01

Brief Summary

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

Detailed Description

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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

Conditions

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Neuropathy;Peripheral

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Group 1 will receive neuromodulation.

Group Type EXPERIMENTAL

Abbott® DRG / Abbott®/Medtronic® SCS

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Control Group

Intervention Type OTHER

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.

Intervention Type DEVICE

Control Group

Participants will not receive any intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Anesthesia Education and Research

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

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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