Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer

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.

Inclusion Criteria:

- Breast cancer (any stage)

- Previously or currently receiving taxane-based chemotherapy

- Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be
secondary to taxane-based therapy

- Ability and willingness to understand and sign an informed consent

Exclusion Criteria:

- Self-reported or documented history of pre-existing peripheral neuropathy prior to
initiation of taxane chemotherapy

- Unable to provide history