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NCT Number: NCT05378256

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Orléans

Orléans, 45067, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical scales of CIPN

Other

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 outcomes

  1. Nerve conduction parameters

    Time frame: 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.

  2. Nerve conduction parameters

    Time frame: Immediately after 4th Chemotherapy course

    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.

  3. Nerve conduction parameters

    Time frame: Immediately at the end of all the Chemotherapy courses

    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.

  4. Nerve conduction parameters

    Time frame: 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 outcomes

  1. Longitudinal study of the evolution of markers of neuropathy

    Time frame: 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.

  2. Longitudinal study of the evolution of markers of neuropathy

    Time frame: Before Chemotherapy first cure

    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.

  3. Longitudinal study of the evolution of markers of neuropathy

    Time frame: Before Chemotherapy first cure

    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

  4. Longitudinal study of the evolution of markers of neuropathy

    Time frame: 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

  5. Sudoscan (dysautonomic function)

    Time frame: 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

  6. Gait parameters using FeetMe device

    Time frame: 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.

  7. Biological dosages

    Time frame: Before Chemotherapy (T1)

    Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1)

  8. Biological dosages

    Time frame: 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

  9. Vincristin dosage

    Time frame: 1/4 hour after ending of each infusion

    Vincristin dosage will be performed at each infusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: NeuroTox-L

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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