Clinical trial NCT03958747: Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
Official title: A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Colorectal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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.

Primary outcomes:
measure: Tibial Nerve Cross-Sectional Area Comparison
timeFrame: Up to 30 days
Secondary outcomes:
measure: Sural Nerve Cross-Sectional Area Comparison
timeFrame: Up to 30 days
measure: Amplitude of Nerve Response of Tibial Nerve
timeFrame: Up to 30 days
measure: Amplitude of Nerve Response of Sural Nerve
timeFrame: Up to 30 days
measure: Distal Latency of Nerve Response of Tibial Nerve
timeFrame: Up to 30 days
measure: Distal Latency of Nerve Response of Sural Nerve
timeFrame: Up to 30 days
measure: Conduction Velocity of Nerve Response of Tibial Nerve
timeFrame: Up to 30 days
measure: Conduction Velocity of Nerve Response of Sural Nerve
timeFrame: Up to 30 days
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire
timeFrame: Up to 30 days
measure: Reduction of Intraepidermal Nerve Fiber Density
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Roy Strowd, MD
role: PRINCIPAL_INVESTIGATOR
References: