Nervous System Diseases

All Conditions

Neoplasms

Digestive System Diseases

Peripheral Nervous System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuromuscular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Participants will undergo a serial and tibial nerve ultrasound

Ultrasound - Serial and Tibial Nerve

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

Skin Biopsy

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.

Abbreviated Neurologic Exam

Blood draw

Nerve Conduction Study

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

QLQ-CIPN20 Questionnaire Administration

Ashley Fansler, RN

Roy Strowd, MD

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.

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

Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy

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

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).

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 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 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 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.

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.

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.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Vincristine

Patients with lymphoma will be evaluated before chemotherapy (T1), after 4 cycles (T2), at the end of the chemotherapy treatment (If more than 4 cycles) (T3) and 6 month after the end of chemotherapy (T4).

Clinical scales of CIPN

Pascal AUZOU, Dr

Pascal AUZOU, DR

Vincristine-induced peripheral neuropathy, which is commonly a sensorimotor neuropathy, remains a major complication of lymphoma patients treated with R-CHOP. The investigators propose a clinical, electrophysiological and biological follow up of patients treated by vincristine for lymphoma to determine the factors implied in VIPN occurrence.

Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors

Chemotherapy Induced Peripheral Neuropathy (CIPN) in Lymphoma : Longitudinal Follow up and Prognostic Factors.

Nerve conduction study (NCS) with standard NCS of the tibial and peroneal motor, sural, sural dorsal, superficial peroneal, median, ulnar, and radial sensory nerves. ENMG study will be bilateral at lower limb and only left side at upper limb. T-Reflex and F-waves will be used to assess proximal nerve function.

The evolutionary follow-up will be done from NCI-CTC (National Cancer Institute-Common Toxicity Criteria) score (ranging from 0 - 4). Higher score mean a worse outcome.

The evolutionary follow-up will be done from the TNS (Total Neuropathy Score) scale which is based on symptoms, signs and basic instrumental evaluations and provides a much larger range of scoring values (0 - 40) than NCI-CTC scale, thus allowing the severity of CIPN to be graded more precisely. The TNS has so far been used to assess the neurotoxicity of various CIPN-relevant chemotherapeutic agents, and its results are clearly correlated with the clinically relevant results of NCI-CTC scale, which are commonly used by oncologists. Higher scores mean a worse outcome.

The evolutionary follow-up will be done from the DN4 scale which is a pain scale (ranging from 0 to 10) where 0 equals to no pain and 10 to maximum pain

The evolutionary follow-up will be done from the EORTC QOL-CIPN20 which is a quality of life scale (ranging from 0-80) where the lower score correspond to less symptoms and the highest score correspond to higher symptoms

Sudoscan performs a quantitative evaluation of sweat gland function based on an electrochemical reaction between sweat chlorides and electrodes in contact with the hands and feet using reverse iontophoresis and chronoamperometry

The quantified evaluation of the subjects' walking will be carried out instrumentally over a 10-meter course using the FeetMe.

FeetMeR Monitor insole (FeetMe, Paris, France) is a new wearable medical device (class Im) combining plantar pressure sensors, accelerometers, and gyroscopes.

Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1)

Markers of peripheral nervous system damage (Claudine-5, Occludine, VEGF (Vascular Endothelial Growth Factor), BDNF (Brain-Derived Neurotrophic Factor)) will be mesured

Vincristin dosage will be performed at each infusion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy	NCT03958747	Gastrointestina... Colorectal Canc...	Ultrasound - Se... Skin Biopsy Abbreviated Neu... Blood draw Nerve Conductio... QLQ-CIPN20 Ques...	18 Years -	Wake Forest University Health Sciences
Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors	NCT05378256	Lymphoma Peripheral Neur...	Clinical scales...	18 Years -	Centre Hospitalier Régional d'Orléans

Spots Global Cancer Trial Database for nerve conduction study