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NCT Number: NCT03139435

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

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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Key information

Conditions

Peripheral Neuropathy Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases 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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

Undergo skin biopsy

Other names: Bx

Questionnaire Administration

Other

Ancillary studies

Ultrasound Tomography

Diagnostic Test

Undergo peripheral nerve ultrasound

Primary outcomes

  1. Tibial Nerve Cross-sectional Area

    Time frame: 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 outcomes

  1. Amplitude of Nerve Response - Ankle

    Time frame: 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).

  2. Conduction Velocity of Nerve Response - Tibial

    Time frame: 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).

  3. Distal Latency of Nerve Response - Ankle

    Time frame: 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).

  4. Nerve Fiber Density in the Skin

    Time frame: 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.

  5. Self-reported Neuropathy Score

    Time frame: 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.

  6. Sural Nerve Cross-sectional Area

    Time frame: 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.

Other outcomes

  1. Serum Levels of Inflammatory Molecules

    Time frame: Up to 30 days

    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.

  2. The Number of Activated Mast Cells

    Time frame: Up to 30 days

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 4, 2017
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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