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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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Start Date
December 17, 2019
Primary Completion Date
November 26, 2025
Completion Date
November 26, 2025
Last Updated
March 19, 2026
20
ACTUAL participants
Ultrasound - Serial and Tibial Nerve
DIAGNOSTIC_TEST
Skin Biopsy
PROCEDURE
Abbreviated Neurologic Exam
OTHER
Blood draw
OTHER
Nerve Conduction Study
DIAGNOSTIC_TEST
QLQ-CIPN20 Questionnaire Administration
OTHER
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
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