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Lead
Wake Forest University Health Sciences
With
National Cancer Institute (NCI)
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
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
Unable to provide history
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