Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

Colorectal Cancer Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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.

Secondary Objective

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

II. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients.

III. 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 patients.

IV. 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 patients.

Exploratory Objectives I. To assess activated mast cells in skin biopsies in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.

II. To assess serum inflammatory markers in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.

III. Exploratory Cohort (Oxaliplatin-induced peripheral neuropathy, OIPN) Objectives

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

V. 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

VI. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients

VII. 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 patients

VIII. 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 patients ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Peripheral Nervous System Diseases

• NCT number: NCT03958747
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Ashley Fansler, RN
• Phone: 336-716-5440
• Email: arcarrol@wakehealth.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2019
• Completion date: October 2024