NCT03958747

Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Gastrointestinal Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-17
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2019-05-22
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study