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

NCT03139435 | Completed Results DMC FDA Device

• 4 other identifiers: IRB00043631NCI-2017-00680CCCWFU 97217P30CA012197
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Amplitude of Nerve Response - Ankle

  Up to 30 days

• Conduction Velocity of Nerve Response - Tibial

  Up to 30 days

• Distal Latency of Nerve Response - Ankle

  Up to 30 days

• Nerve Fiber Density in the Skin

  Up to 30 days

• Self-reported Neuropathy Score

  Up to 30 days

Other Outcomes (2)

• Serum Levels of Inflammatory Molecules

  Up to 30 days

• The Number of Activated Mast Cells

  Up to 30 days

Study Arms (1)

Diagnostic (ultrasound)

EXPERIMENTAL

Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

Procedure: Biopsy; Other: Questionnaire Administration; Diagnostic Test: Ultrasound Tomography

Interventions

Biopsy PROCEDURE

Undergo skin biopsy

Also known as: Bx

Diagnostic (ultrasound)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (ultrasound)

Ultrasound Tomography DIAGNOSTIC_TEST

Undergo peripheral nerve ultrasound

Diagnostic (ultrasound)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
• Unable to provide history

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

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

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Roy Strowd
• Organization: Wake Forest Baptist Comprehensive Cancer Center

rstrowd@wakehealth.edu

336-713-5440

Study Officials

• Roy Strowd

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 4, 2017
• Study Start: May 11, 2017
• Primary Completion: December 12, 2018
• Study Completion: January 11, 2019
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2024-04

Locations

US (1)