A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Neuropathy
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Tibial Nerve Cross-sectional Area
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
- 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)
- Sural Nerve Cross-sectional Area(Up to 30 days)
- Amplitude of Nerve Response - Ankle(Up to 30 days)
- Self-reported Neuropathy Score(Up to 30 days)