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

Not Applicable

Completed

• Conditions: Stage II Breast Cancer; Stage IIIB Breast Cancer; Peripheral Neuropathy; Stage 0 Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIC Breast Cancer; Stage III Breast Cancer
• Interventions: Procedure: Biopsy; Other: Questionnaire Administration; Diagnostic Test: Ultrasound Tomography

• Registration Number: NCT03139435
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-04
• Study Start: 2017-05-11
• Primary Completion: 2018-12-12
• Study Completion: 2019-01-11
• Results First Submitted: 2023-09-19
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Results First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (ultrasound)	Questionnaire Administration	Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
Diagnostic (ultrasound)	Biopsy	Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
Diagnostic (ultrasound)	Ultrasound Tomography	Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

Primary Outcome Measures

Name	Time	Method
Tibial Nerve Cross-sectional Area	Up to 30 days	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

Secondary Outcome Measures

Name	Time	Method
Conduction Velocity of Nerve Response - Tibial	Up to 30 days	Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial).
Distal Latency of Nerve Response - Ankle	Up to 30 days	Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle).
Nerve Fiber Density in the Skin	Up to 30 days	Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density.
Sural Nerve Cross-sectional Area	Up to 30 days	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.
Amplitude of Nerve Response - Ankle	Up to 30 days	Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle).
Self-reported Neuropathy Score	Up to 30 days	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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States