Clinical trial NCT03139435: Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer
Official title: A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-04
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tibial Nerve Cross-sectional Area
timeFrame: Up to 30 days
Secondary outcomes:
measure: Amplitude of Nerve Response - Ankle
timeFrame: Up to 30 days
measure: Conduction Velocity of Nerve Response - Tibial
timeFrame: Up to 30 days
measure: Distal Latency of Nerve Response - Ankle
timeFrame: Up to 30 days
measure: Nerve Fiber Density in the Skin
timeFrame: Up to 30 days
measure: Self-reported Neuropathy Score
timeFrame: Up to 30 days
measure: Sural Nerve Cross-sectional Area
timeFrame: Up to 30 days
Other outcomes:
measure: Serum Levels of Inflammatory Molecules
timeFrame: Up to 30 days
measure: The Number of Activated Mast Cells
timeFrame: Up to 30 days
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Roy Strowd
role: PRINCIPAL_INVESTIGATOR
References: