NCT03139435

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo skin biopsy
OTHER	Questionnaire Administration	Ancillary studies
DIAGNOSTIC_TEST	Ultrasound Tomography	Undergo peripheral nerve ultrasound

Timeline

• Start date: 2017-05-11
• Primary completion: 2018-12-12
• Completion: 2019-01-11
• First posted: 2017-05-04
• Last updated: 2024-04-08
• Results posted: 2024-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study