Gastrointestinal Cancer, Colorectal Cancer
Conditions
Brief summary
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.
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. 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
Interventions
DIAGNOSTIC_TESTUltrasound - Serial and Tibial Nerve
Participants will undergo a serial and tibial nerve ultrasound
PROCEDURESkin 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
OTHERAbbreviated 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.
OTHERBlood draw
12 ml blood sample will be taken
DIAGNOSTIC_TESTNerve Conduction Study
Sural and tibial nerve assessments
OTHERQLQ-CIPN20 Questionnaire Administration
Self-reported neuropathy scoring questionnaire completed same day as blood draw.
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 | 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRoy Strowd, MD
Wake Forest University Health Sciences
Outcome results
None listed