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

Wake Forest University (WFU)

Status: Completed

Conditions: Stage IIIA Breast Cancer; Peripheral Neuropathy; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Stage I Breast Cancer; Stage 0 Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Stage III Breast Cancer; Stage IV Breast Cancer

Treatments: Diagnostic Test: Ultrasound Tomography; Other: Questionnaire Administration; Procedure: Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03139435

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2017-00680 (Registry Identifier)

CCCWFU 97217 (Other Identifier)

IRB00043631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Diagnostic (ultrasound)

Experimental group

Description:

Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

Treatment:

Procedure: Biopsy

Other: Questionnaire Administration

Diagnostic Test: Ultrasound Tomography