NCT05378256 - Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

40

Conditions

Lymphoma Peripheral Neuropathy

Interventions

Clinical scales of CIPNOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHR Orléans

Orléans, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months after the end of all the cures

Secondary Outcomes

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.