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

Not Applicable

Recruiting

• Conditions: Lymphoma; Peripheral Neuropathy
• Interventions: Other: Clinical scales of CIPN

• Registration Number: NCT05378256
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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).

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical scales of CIPN	Clinical 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).

Primary Outcome Measures

Name	Time	Method
Nerve conduction parameters	6 months after the end of all the cures	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 Outcome Measures

Name	Time	Method
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
Biological dosages	Before Chemotherapy (T1)	Markers of peripheral nervous system damage (Claudine-5, Occludine, VEGF (Vascular Endothelial Growth Factor), BDNF (Brain-Derived Neurotrophic Factor)) will be mesured
Vincristin dosage	1/4 hour after ending of each infusion	Vincristin dosage will be performed at each infusion
Longitudinal study of the evolution of markers of neuropathy	Before Chemotherapy first cure	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
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.

Trial Locations

Locations (1)

CHR Orléans; 🇫🇷 Orléans, France