LymphomaNeuroTox-LNCT05378256
Chemotherapy Induced Peripheral Neuropathy (CIPN) and Lymphoma Longitudinal Follow-up and Prognostic Factors
A study testing Clinical scales of CIPN in people with Lymphoma and Peripheral Neuropathy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Peripheral Neuropathy
- What is being tested?
- Clinical scales of CIPN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2022to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Persons under forced psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Persons unable to express their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemotherapy Induced Peripheral Neuropathy (CIPN) in 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.
Read the 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).
- Conditions
- Lymphoma, Peripheral Neuropathy
- Being tested
- Clinical scales of CIPN
- Keywords
- Chemotherapy induced peripheral neuropathy, Nerve conduction study, Vincristine, lymphoma
- Medical subject headings
- Lymphoma, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Clinical scales of CIPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after the end of all the cures
Secondary outcomes (9)
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.
Measured: Before Chemotherapy first cure
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.
Measured: Before Chemotherapy first cure
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
Measured: Before Chemotherapy first cure
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
Measured: Before Chemotherapy first cure
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
Measured: Before Chemotherapy first cure
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.
Measured: Before Chemotherapy (T1)
Biological dosages
Immunological factors (IL-6, IL-1b, TNF-a, IL-33, IL-10, CXCL1, CX3CL1)
Measured: Before Chemotherapy (T1)
Biological dosages
Markers of peripheral nervous system damage (Claudine-5, Occludine, VEGF (Vascular Endothelial Growth Factor), BDNF (Brain-Derived Neurotrophic Factor)) will be mesured
Measured: Before Chemotherapy (T1)
Vincristin dosage
Vincristin dosage will be performed at each infusion
Measured: 1/4 hour after ending of each infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start10 Jan 2022
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AUZOU, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378256
- Sponsor's protocol ID
- CHRO-2021-09
- Acronym
- NeuroTox-L
- Status last verified
- Apr 2025
- First submitted
- 12 Jan 2022
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21908200Caccia 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.
PubMed 72789Casey 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.
PubMed 5428794Casey 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.
PubMed 4348690
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Induced Peripheral Neuropathy (CIPN) in Lymphoma : Longitudinal Follow up and Prognostic Factors.
- ClinicalTrials.gov ID
- NCT05378256
- Acronym / sponsor ID
- NeuroTox-L / CHRO-2021-09
- Conditions
- Lymphoma, Peripheral Neuropathy
- Keywords
- Chemotherapy induced peripheral neuropathy, Nerve conduction study, Vincristine, lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical scales of CIPN | Other | Other: Clinical scales of CIPNPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical scales of CIPNPatients 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). | Other | Clinical scales of CIPN |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
Longitudinal study of the evolution of markers of neuropathy
Time frame: Before Chemotherapy first cure
Longitudinal study of the evolution of markers of neuropathy
Time frame: Before Chemotherapy first cure
Longitudinal study of the evolution of markers of neuropathy
Time frame: Before Chemotherapy first cure
Longitudinal study of the evolution of markers of neuropathy
Time frame: Before Chemotherapy first cure
Sudoscan (dysautonomic function)
Time frame: Before Chemotherapy first cure
Gait parameters using FeetMe device
Time frame: Before Chemotherapy (T1)
Biological dosages
Time frame: Before Chemotherapy (T1)
Biological dosages
Time frame: Before Chemotherapy (T1)
Vincristin dosage
Time frame: 1/4 hour after ending of each infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Background: PubMed 21908200Argyriou 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.
- Background: PubMed 72789Caccia 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.
- Background: PubMed 5428794Casey 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.
- Background: PubMed 4348690Casey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AUZOU, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical scales of CIPN in people with Lymphoma and Peripheral Neuropathy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction parameters (time frame: Before Chemotherapy first cure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378256, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.