Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
NCT03958747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-19
Summary
This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in participants with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer participants treated with the chemotherapy drug called oxaliplatin.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
Ultrasound - Serial and Tibial Nerve
Participants will undergo a serial and tibial nerve ultrasound
- PROCEDURE
-
Skin Biopsy
Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
- OTHER
-
Abbreviated Neurologic Exam
Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
- OTHER
-
Blood draw
12 ml blood sample will be taken
- DIAGNOSTIC_TEST
-
Nerve Conduction Study
Sural and tibial nerve assessments
- OTHER
-
QLQ-CIPN20 Questionnaire Administration
Self-reported neuropathy scoring questionnaire completed same day as blood draw.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Roy Strowd, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-17
- Primary Completion
- 2025-11-26
- Completion
- 2025-11-26
- FDA Device
- Yes
Countries
- United States
Study Locations
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