Clinical trial NCT05378256: Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors
Official title: Chemotherapy Induced Peripheral Neuropathy (CIPN) in Lymphoma : Longitudinal Follow up and Prognostic Factors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Peripheral Neuropathy
Keywords: Chemotherapy induced peripheral neuropathy
Nerve conduction study
Vincristine
lymphoma
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Nerve conduction parameters
timeFrame: Before Chemotherapy first cure
measure: Nerve conduction parameters
timeFrame: Immediately after 4th Chemotherapy course
measure: Nerve conduction parameters
timeFrame: Immediately at the end of all the Chemotherapy courses
measure: Nerve conduction parameters
timeFrame: 6 months after the end of all the cures
Secondary outcomes:
measure: Longitudinal study of the evolution of markers of neuropathy
timeFrame: Before Chemotherapy first cure
measure: Longitudinal study of the evolution of markers of neuropathy
timeFrame: Before Chemotherapy first cure
measure: Longitudinal study of the evolution of markers of neuropathy
timeFrame: Before Chemotherapy first cure
measure: Longitudinal study of the evolution of markers of neuropathy
timeFrame: Before Chemotherapy first cure
measure: Sudoscan (dysautonomic function)
timeFrame: Before Chemotherapy first cure
measure: Gait parameters using FeetMe device
timeFrame: Before Chemotherapy (T1)
measure: Biological dosages
timeFrame: Before Chemotherapy (T1)
measure: Biological dosages
timeFrame: Before Chemotherapy (T1)
measure: Vincristin dosage
timeFrame: 1/4 hour after ending of each infusion
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR d'Orléans
name: Pascal AUZOU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012 Apr;82(1):51-77. doi: 10.1016/j.critrevonc.2011.04.012. Epub 2011 Sep 10.
citation: Caccia MR, Comotti B, Ubiali E, Lucchetti A. Vincristine polyneuropathy in man. A clinical and electrophysiological study. J Neurol. 1977 Aug 18;216(1):21-6. doi: 10.1007/BF00312811.
citation: Casey EB, Fullerton PM, Jelliffe AW. Vincristine neurotoxicity: a clinical and electrophysiological study of eighteen patients. Clin Sci. 1970 Apr;38(4):23P-24P. doi: 10.1042/cs038023pb. No abstract available.
citation: Casey EB, Jellife AM, Le Quesne PM, Millett YL. Vincristine neuropathy. Clinical and electrophysiological observations. Brain. 1973;96(1):69-86. doi: 10.1093/brain/96.1.69. No abstract available.