Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

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: Colorectal Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Diagnostic test: Ultrasound - Serial and Tibial Nerve; Procedure: Skin Biopsy; Other: Abbreviated Neurologic Exam; Other: Blood draw; Diagnostic test: Nerve Conduction Study; Other: QLQ-CIPN20 Questionnaire Administration

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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	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	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	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	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	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	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	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

• 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

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): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Gastrointestinal Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Diagnostic Techniques, Neurological; Electrodiagnosis; Nerve Conduction Studies; Blood Specimen Collection
• 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