Lymphoma, Peripheral Neuropathy
Conditions
Keywords
Chemotherapy induced peripheral neuropathy, Nerve conduction study, Vincristine, lymphoma
Brief summary
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
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).
Interventions
OTHERClinical scales of CIPN
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).
Sponsors
Centre Hospitalier Régional d'Orléans
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve conduction parameters | Before Chemotherapy first cure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal study of the evolution of markers of neuropathy | Before Chemotherapy first cure | 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. |
| Sudoscan (dysautonomic function) | Before Chemotherapy first cure | 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 |
| Gait parameters using FeetMe device | Before Chemotherapy (T1) | 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. |
| Biological dosages | Before Chemotherapy (T1) | Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1) |
| Vincristin dosage | 1/4 hour after ending of each infusion | Vincristin dosage will be performed at each infusion |
Countries
France
Outcome results
None listed