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

Stage IV Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139435
• Other study ID #: IRB00043631
• Secondary ID: NCI-2017-00680CC
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: January 11, 2019

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 11, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Peripheral Nervous System Diseases
• 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

Procedure:
• Biopsy
Undergo skin biopsy

Other:
• Questionnaire Administration
Ancillary studies

Diagnostic Test:
• Ultrasound Tomography
Undergo peripheral nerve ultrasound

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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