Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer; Colorectal Cancer
• Interventions: Diagnostic Test: Ultrasound - Serial and Tibial Nerve; Procedure: Skin Biopsy; Other: Abbreviated Neurologic Exam; Other: Blood draw; Diagnostic Test: Nerve Conduction Study; Other: QLQ-CIPN20 Questionnaire Administration

• Registration Number: NCT03958747
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in patients with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer patients treated with the chemotherapy drug called a oxaliplatin.

Detailed Description

Primary Objectives

I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.

Secondary Objective

I. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.

II. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients.

III. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients.

IV. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients.

Exploratory Objectives I. To assess activated mast cells in skin biopsies in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.

II. To assess serum inflammatory markers in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.

III. Exploratory Cohort (Oxaliplatin-induced peripheral neuropathy, OIPN) Objectives

IV. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and OIPN patients

V. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients

VI. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients

VII. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients

VIII. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-22
• Study Start: 2019-12-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Gastrointestinal cancer
• Colorectal cancer (any stage)
• Previously or currently receiving oxaliplatin -based chemotherapy.
• Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -based therapy.
• Ability and willingness to understand and sign an informed consent.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound - Serial and Tibial Nerve	Undergo peripheral nerve ultrasound
Ultrasound	Blood draw	Undergo peripheral nerve ultrasound
Ultrasound	Skin Biopsy	Undergo peripheral nerve ultrasound
Ultrasound	Nerve Conduction Study	Undergo peripheral nerve ultrasound
Ultrasound	Abbreviated Neurologic Exam	Undergo peripheral nerve ultrasound
Ultrasound	QLQ-CIPN20 Questionnaire Administration	Undergo peripheral nerve ultrasound

Primary Outcome Measures

Name	Time	Method
Tibial Nerve Cross-Sectional Area Comparison	Up to 30 days	Tibial nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).

Secondary Outcome Measures

Name	Time	Method
Amplitude of Nerve Response of Sural Nerve	Up to 30 days	Amplitude will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Sural Nerve Cross-Sectional Area Comparison	Up to 30 days	Sural nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
Amplitude of Nerve Response of Tibial Nerve	Up to 30 days	Amplitude will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Distal Latency of Nerve Response of Tibial Nerve	Up to 30 days	Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Distal Latency of Nerve Response of Sural Nerve	Up to 30 days	Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Conduction Velocity of Nerve Response of Tibial Nerve	Up to 30 days	Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire	Up to 30 days	A 20-item self-reported neuropathy score questionnaire for participants to report neuropathy symptoms or problems. Scoring ranges from 1-4, 1 being not at all, 4 being very much.
Conduction Velocity of Nerve Response of Sural Nerve	Up to 30 days	Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Reduction of Intraepidermal Nerve Fiber Density	Up to 30 days	Biopsies will be taken from the distal leg or proximal thigh to evaluate peripheral neuropathy. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and intraepidermal nerve fiber density.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States