Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

NCT03958747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Roy Strowd, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2025-11-26
Completion
2025-11-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958747 on ClinicalTrials.gov