This trial studies how well ultrasound works in diagnosing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer. Diagnostic procedures, such as ultrasound, may help find and diagnose peripheral neuropathy that may have been caused by a chemotherapy drug called oxaliplatin.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03958747.
PRIMARY OBJECTIVES:
I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between oxaliplatin-induced peripheral neuropathy (OIPN) patients and historical data among healthy adults and OIPN patients.
II. To compare sural sensory nerve ultrasound CSA between OIPN patients and historical data among healthy adults and OIPN patients.
SECONDARY OBJECTIVES:
I. To determine if the above changes in nerve CSA correlate with nerve conduction studies (NCS) changes in the same OIPN patients.
II. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) in the same OIPN patients.
III. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same OIPN patients.
OUTLINE:
Patients undergo an ultrasound and a nerve conduction study of the lower legs. Patients also undergo skin biopsy of the lower leg.
After completion of study, patients are followed up for 30 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRoy Ervin Strowd
