Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

Wake Forest University (WFU)

Status

Completed

Conditions

Gastrointestinal Cancer

Colorectal Cancer

Treatments

Diagnostic Test: Nerve Conduction Study

Other: Blood draw

Diagnostic Test: Ultrasound - Serial and Tibial Nerve

Other: Abbreviated Neurologic Exam

Other: QLQ-CIPN20 Questionnaire Administration

Procedure: Skin Biopsy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03958747

IRB00059662

P30CA012197 (U.S. NIH Grant/Contract)

WFBCCC 97219 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria