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

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

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.

Study Overview

• Status: Completed
• Conditions: Stage 0 Breast Cancer; Stage I Breast Cancer; Peripheral Neuropathy; Stage IV Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIC Breast Cancer; Stage III Breast Cancer
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biopsy; Diagnostic test: Ultrasound Tomography

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (ultrasound); Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biopsy; Undergo skin biopsy; Other Names: Bx; Diagnostic test: Ultrasound Tomography; Undergo peripheral nerve ultrasound

What is the study measuring?

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 - Ankle	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).	Up to 30 days
Conduction Velocity of Nerve Response - Tibial	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).	Up to 30 days
Distal Latency of Nerve Response - Ankle	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).	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 distal 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Levels of Inflammatory Molecules	Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.	Up to 30 days
The Number of Activated Mast Cells	Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.	Up to 30 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Roy Strowd, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): January 11, 2019

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neuromuscular Diseases; Carcinoma in Situ; Breast Neoplasms; Peripheral Nervous System Diseases; Breast Carcinoma In Situ
• Other Study ID Numbers: IRB00043631; P30CA012197 (U.S. NIH Grant/Contract); NCI-2017-00680 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 97217 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes