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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2019-01-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (ultrasound)

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

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

Undergo skin biopsy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Ultrasound Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo peripheral nerve ultrasound

Interventions

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Biopsy

Undergo skin biopsy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Ultrasound Tomography

Undergo peripheral nerve ultrasound

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Bx

Eligibility Criteria

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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