Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

July 17, 2026 updated by: Wake Forest University Health Sciences

A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in participants with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer participants treated with the chemotherapy drug called oxaliplatin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.

and oxaliplatin-induced peripheral neuropathy patients

II. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients

Secondary Objectives

I. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction studies changes in the same oxaliplatin-induced peripheral neuropathy participants

II. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy participants

III. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy participants

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any gastrointestinal cancer including colon, rectal, colorectal, pancreas, esophageal, or other (any stage)
  • Previously or currently receiving oxaliplatin -based chemotherapy.
  • Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -based therapy.
  • Ability and willingness to understand and sign an informed consent.

Exclusion Criteria:

  • Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy.
  • Unable to provide history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
Undergo peripheral nerve ultrasound
Diagnostic test: Ultrasound - Serial and Tibial Nerve
Participants will undergo a serial and tibial nerve ultrasound
Procedure: Skin Biopsy
Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
Other: Abbreviated Neurologic Exam
Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
Other: Blood draw
12 ml blood sample will be taken
Diagnostic test: Nerve Conduction Study
Sural and tibial nerve assessments
Other: QLQ-CIPN20 Questionnaire Administration
Self-reported neuropathy scoring questionnaire completed same day as blood draw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tibial Nerve Cross-Sectional Area Comparison
Time Frame: Up to 30 days
Tibial nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sural Nerve Cross-Sectional Area Comparison
Time Frame: Up to 30 days
Sural nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
Up to 30 days
Amplitude of Nerve Response of Tibial Nerve
Time Frame: Up to 30 days
Amplitude will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Up to 30 days
Amplitude of Nerve Response of Sural Nerve
Time Frame: Up to 30 days
Amplitude will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Up to 30 days
Distal Latency of Nerve Response of Tibial Nerve
Time Frame: Up to 30 days
Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Up to 30 days
Distal Latency of Nerve Response of Sural Nerve
Time Frame: Up to 30 days
Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Up to 30 days
Conduction Velocity of Nerve Response of Tibial Nerve
Time Frame: Up to 30 days
Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Up to 30 days
Conduction Velocity of Nerve Response of Sural Nerve
Time Frame: Up to 30 days
Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Up to 30 days
Reduction of Intraepidermal Nerve Fiber Density
Time Frame: Up to 30 days
Biopsies will be taken from the distal leg or proximal thigh to evaluate peripheral neuropathy. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and intraepidermal nerve fiber density.
Up to 30 days
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire
Time Frame: Up to 30 days
The EORTC QLQ-CIPN20 is a 20-item patient-reported questionnaire evaluating chemotherapy-induced peripheral neuropathy symptoms across sensory, motor, and autonomic subscales. Items are scored from 1 (Not at all) to 4 (Very much) based on the past week, with scores linearly converted to a 0-100 scale. Higher scores indicate greater symptom severity.
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roy Strowd, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Actual)

November 26, 2025

Study Completion (Actual)

November 26, 2025

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00059662
  • P30CA012197 (U.S. NIH Grant/Contract)
  • WFBCCC 97219 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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