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NCT Number: NCT03958747

Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

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.

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Key information

Conditions

Gastrointestinal Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

About this study

Primary Objectives

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

and oxaliplatin-induced peripheral neuropathy patients

II. 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

Secondary Objectives

I. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction studies changes in the same oxaliplatin-induced peripheral neuropathy participants

II. 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 participants

III. 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 participants

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any gastrointestinal cancer including colon, rectal, colorectal, pancreas, esophageal, or other (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

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

Treatment and study plan

Ultrasound - Serial and Tibial Nerve

Diagnostic Test

Participants will undergo a serial and tibial nerve ultrasound

skin biopsy

Procedure

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

Abbreviated Neurologic Exam

Other

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.

Blood Draw

Other

12 ml blood sample will be taken

Nerve Conduction Study

Diagnostic Test

Sural and tibial nerve assessments

QLQ-CIPN20 Questionnaire Administration

Other

Self-reported neuropathy scoring questionnaire completed same day as blood draw.

Primary outcomes

  1. Tibial Nerve Cross-Sectional Area Comparison

    Time frame: 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 outcomes

  1. Sural Nerve Cross-Sectional Area Comparison

    Time frame: 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).

  2. Amplitude of Nerve Response of Tibial Nerve

    Time frame: 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.

  3. Amplitude of Nerve Response of Sural Nerve

    Time frame: 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.

  4. Distal Latency of Nerve Response of Tibial Nerve

    Time frame: 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.

  5. Distal Latency of Nerve Response of Sural Nerve

    Time frame: 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.

  6. Conduction Velocity of Nerve Response of Tibial Nerve

    Time frame: 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.

  7. Conduction Velocity of Nerve Response of Sural Nerve

    Time frame: 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.

  8. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire

    Time frame: Up to 30 days

    The EORTC QLQ-CIPN20 is a 20-item patient-reported questionnaire evaluating chemotherapy-induced peripheral neuropathy symptoms across sensory, motor, and autonomic subscales. Items are scored from 1 (Not at all) to 4 (Very much) based on the past week, with scores linearly converted to a 0-100 scale. Higher scores indicate greater symptom severity.

  9. Reduction of Intraepidermal Nerve Fiber Density

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 22, 2019
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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