Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-09 @ 5:59 PM
Study NCT ID:
NCT03139435
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-00680 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CCCWFU 97217 | OTHER | Comprehensive Cancer Center of Wake Forest University | View | |
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |