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

Lymphoma Clinical Trial

— NeuroTox-L  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378256
• Other study ID #: CHRO-2021-09
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: January 2025

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Pascal AUZOU, Dr
• Phone: 0238229947
• Email: pascal.auzou[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	CHR Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Biological dosages	Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1)	Before Chemotherapy (T1)
Secondary	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)
Secondary	Vincristin dosage	Vincristin dosage will be performed at each infusion	1/4 hour after ending of each infusion