Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT03139435
Brief 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.
Detailed 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:
NCT03139435
Study Brief:
Protocol Section:
NCT03139435