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

Study Overview
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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.

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.

Official Title
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A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy

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

Intervention / Treatment
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* Procedure: Biopsy
* Other: Questionnaire Administration
* Diagnostic Test: Ultrasound Tomography


Participation Criteria
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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 Exclusion Criteria: Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy Unable to provide history
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (ultrasound)<br>Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy. | Procedure: Biopsy<br>* Undergo skin biopsy<br>* Other names: Bx;Other: Questionnaire Administration<br>* Ancillary studies<br>Diagnostic Test: Ultrasound Tomography<br>* Undergo peripheral nerve ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tibial nerve cross-sectional area | Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of nerve response | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. | Up to 30 days | 
| Conduction velocity of nerve response | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. | Up to 30 days | 
| Distal latency of nerve response | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. | Up to 30 days | 
| Nerve fiber density in the skin | Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and intraepidermal nerve fiber density. | Up to 30 days | 
| Self-reported neuropathy score | Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale. | Up to 30 days | 
| Sural nerve cross-sectional area | Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable. | Up to 30 days |