Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors (NeuroTox-L)
Primary Purpose
Lymphoma, Peripheral Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical scales of CIPN
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma focused on measuring Chemotherapy induced peripheral neuropathy, Nerve conduction study, Vincristine, lymphoma
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
Sites / Locations
- CHR OrléansRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinical scales of CIPN
Arm 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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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
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
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
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.
Biological dosages
Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1)
Biological dosages
Markers of peripheral nervous system damage (Claudine-5, Occludine, VEGF (Vascular Endothelial Growth Factor), BDNF (Brain-Derived Neurotrophic Factor)) will be mesured
Vincristin dosage
Vincristin dosage will be performed at each infusion
Full Information
NCT ID
NCT05378256
First Posted
January 12, 2022
Last Updated
June 14, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT05378256
Brief Title
Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors
Acronym
NeuroTox-L
Official Title
Chemotherapy Induced Peripheral Neuropathy (CIPN) in Lymphoma : Longitudinal Follow up and Prognostic Factors.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Peripheral Neuropathy
Keywords
Chemotherapy induced peripheral neuropathy, Nerve conduction study, Vincristine, lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical scales of CIPN
Arm Type
Other
Arm 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).
Intervention Type
Other
Intervention Name(s)
Clinical scales of CIPN
Intervention 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).
Primary Outcome Measure Information:
Title
Nerve conduction parameters
Description
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
Title
Nerve conduction parameters
Description
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
Title
Nerve conduction parameters
Description
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
Title
Nerve conduction parameters
Description
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 Outcome Measure Information:
Title
Longitudinal study of the evolution of markers of neuropathy
Description
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.
Time Frame
Before Chemotherapy first cure
Title
Longitudinal study of the evolution of markers of neuropathy
Description
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.
Time Frame
Before Chemotherapy first cure
Title
Longitudinal study of the evolution of markers of neuropathy
Description
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
Time Frame
Before Chemotherapy first cure
Title
Longitudinal study of the evolution of markers of neuropathy
Description
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
Time Frame
Before Chemotherapy first cure
Title
Sudoscan (dysautonomic function)
Description
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
Time Frame
Before Chemotherapy first cure
Title
Gait parameters using FeetMe device
Description
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.
Time Frame
Before Chemotherapy (T1)
Title
Biological dosages
Description
Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1)
Time Frame
Before Chemotherapy (T1)
Title
Biological dosages
Description
Markers of peripheral nervous system damage (Claudine-5, Occludine, VEGF (Vascular Endothelial Growth Factor), BDNF (Brain-Derived Neurotrophic Factor)) will be mesured
Time Frame
Before Chemotherapy (T1)
Title
Vincristin dosage
Description
Vincristin dosage will be performed at each infusion
Time Frame
1/4 hour after ending of each infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal AUZOU, Dr
Phone
0238229947
Email
pascal.auzou@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal AUZOU, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal AUZOU, DR
Phone
+33 2 38 22 99 47
Email
pascal.auzou@chr-orleans.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
21908200
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.
Results Reference
background
PubMed Identifier
72789
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.
Results Reference
background
PubMed Identifier
5428794
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.
Results Reference
background
PubMed Identifier
4348690
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.
Results Reference
background
Learn more about this trial
Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors
We'll reach out to this number within 24 hrs