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Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03958747
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : December 22, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Colorectal Cancer 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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasound
Undergo peripheral nerve ultrasound
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    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.

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy.
  • Unable to provide history.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958747


Contacts
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Contact: Ashley Fansler, RN 336-716-5440 arcarrol@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ashley Fansler, RN         
Principal Investigator: Roy Strowd, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03958747    
Other Study ID Numbers: IRB00059662
P30CA012197 ( U.S. NIH Grant/Contract )
WFBCCC 97219 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Peripheral Nervous System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Neuromuscular Diseases
Nervous System Diseases