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A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
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.
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Start Date
May 11, 2017
Primary Completion Date
December 12, 2018
Completion Date
January 11, 2019
Last Updated
April 8, 2024
20
ACTUAL participants
Biopsy
PROCEDURE
Questionnaire Administration
OTHER
Ultrasound Tomography
DIAGNOSTIC_TEST
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT07423390
NCT06401889
Data Source & Attribution
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