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Clinical Trial Summary

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


Clinical Trial Description

PRIMARY OBJECTIVES: I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults. SECONDARY OBJECTIVES: I. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults. II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients. III. 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 TIPN patients. IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients. TERTIARY OBJECTIVES: I. To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings. II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings. OUTLINE: Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy. After completion of study, patients are followed up for 30 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03139435
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase N/A
Start date May 11, 2017
Completion date January 11, 2019

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