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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Lymphoma, Peripheral Neuropathy

Intervention / Treatment
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* Other: Clinical scales of CIPN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of indolent or aggressive B/T NHL confirmed by biopsy and requiring chemotherapy after PCR decision including vincristine, RCHOP/CHOP protocol or CHOEP Accept to participate in the study Age > 18 year Able and willing to provide informed consent Affiliated to a social security system Exclusion Criteria: Life-threatening emergency requiring chemotherapy in extreme urgency Neuro-meningeal damage at diagnosis Protected person (under guardianship or curators) Person under court protection Pregnant or breastfeeding woman Persons deprived of liberty by judicial or administrative decision Persons under forced psychiatric care Persons admitted to a health or social institution for purposes other than research Persons unable to express their consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical scales of CIPN<br>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). | Other: Clinical scales of CIPN<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction parameters | 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. | Before Chemotherapy first cure | 
| Nerve conduction parameters | 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. | Immediately after 4th Chemotherapy course | 
| Nerve conduction parameters | 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. | Immediately at the end of all the Chemotherapy courses | 
| Nerve conduction parameters | 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. | 6 months after the end of all the cures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal study of the evolution of markers of neuropathy | 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. | Before Chemotherapy first cure | 
| Longitudinal study of the evolution of markers of neuropathy | 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. | Before Chemotherapy first cure | 
| Longitudinal study of the evolution of markers of neuropathy | 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 | Before Chemotherapy first cure | 
| Longitudinal study of the evolution of markers of neuropathy | 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 | Before Chemotherapy first cure | 
| Sudoscan (dysautonomic function) | 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 | Before Chemotherapy first cure | 
| Gait parameters using FeetMe device | 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. | Before Chemotherapy (T1) | 
| Biological dosages | Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1) | Before Chemotherapy (T1) | 
| Biological dosages | Markers of peripheral nervous system damage (Claudine-5, Occludine, VEGF (Vascular Endothelial Growth Factor), BDNF (Brain-Derived Neurotrophic Factor)) will be mesured | Before Chemotherapy (T1) | 
| Vincristin dosage | Vincristin dosage will be performed at each infusion | 1/4 hour after ending of each infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy induced peripheral neuropathy, Nerve conduction study, Vincristine, lymphoma