Chemotherapy-induced Peripheral NeuropathySUDOPEDNCT04262778
Diagnostic of Chemotherapy Induced Neuropathy in Children
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine the diagnostic accuracy of a newly developed tool (Electrochemical Skin Conductances (ESC) measurement) easy-to-perform, non-invasive, highly reproductible and not requiring specific training, to identify pediatric chemotherapy-induced-peripheral-neuropathies (CIPN). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- electrochemical skin conductance measurement
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2020to 8 Sep 2023
- Phase
- Observational
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Child receiving a Potentially Neurotoxic Chemotherapy
Who may be able to join
- aged 5-17 years
- initiating a potentially neurotoxic chemotherapy alkaloids (vincristine vinblastine, vinorelbine), Platinum compounds (oxaliplatine, cisplatine, carboplatine), proteasome inhibitors (bortezomib), Thalidomide derivatives, taxanes (such as taxol or taxotere), antiCD30 (brentuximab)
- Information of the legal representative of the patient Affiliated to social security regime or an equivalent system
Who cannot join
- history of peripheric neuropathy
- current antiepileptic medications or other treatment for neurogenic pain (tegretol, neurontin, lyrica, laroxyl, rivotril,… etc)
- distal skin lesions that do not allow electrochemical skin conductance measurement
- child not able to stand during the time of examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Electrochemical Skin Conductance Measurement in Paediatric Small Fibre Neuropathy Following Neurotoxic Chemotherapy
The purpose of this study is to determine the diagnostic accuracy of a newly developed tool (Electrochemical Skin Conductances (ESC) measurement) easy-to-perform, non-invasive, highly reproductible and not requiring specific training, to identify pediatric chemotherapy-induced-peripheral-neuropathies (CIPN). CIPN are a frequent (20 to 75% depending on the drug), early and potentially severe long-lasting and dose limiting adverse effect of treatments in immuno-hematology and cancerology. The pathophysiology, the chronology of injury (ie small then large sensory nerve fiber or vice-versa) and the age-related short/long-term impact on peripheral nerves remain largely not understood. Clinical signs of CIPN are highly heterogenous, often under-recognized and include diverse sensory symptoms and pain. Persistent loss of sensation and strength as well as neuropathic pain may have a short/long-term impact in term of functional limitations and quality of life. There is a lack of specific and sensitive measurement tools for CIPN in the pediatric population. Neurophysiological tools (except electro-neuro-myography allowing only the assessment of large myelinated nerves) are not implemented in the pediatric oncology-hematology everyday practice: they are often invasive and/or poorly reproducible, not accessible for "bedside" follow-up, and lacking normative values, thus often dedicated only to research. ESC may provide an early and quantitative assessment of small fiber dysfunction in children, a prerequisite for the identification of additional preventive or curative approaches in CIPN.
Read the detailed description
Epidemiology and suggested mechanisms involved in pediatric chemotherapy induced neuropathy: Pediatric chemotherapy induced peripheral neuropathy (CIPN) is an early (often occurring within the first three months), potentially severe long-lasting and dose limiting adverse effect of treatment in immuno-hematology and cancerology. It constitutes the second most common cause of dose limitation compromising therapy efficacy after hematological adverse effects. Expanding number of potentially toxic treatment for the peripheral nervous system are currently used. Peripheral nerve toxicity has been mainly described with the platinum-based antineoplastics (particularly oxaliplatin and cisplatin), vinca-alkaloids (particularly vincristine and vinblastine), taxanes (paclitaxel, docetaxel), proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide). Vinca-alkaloids are used for treatment of acute leukemia, lymphoma, various solid tumors and are responsible for neuropathy of any grade (National Cancer Institute Common Terminology Criteria for Adverse Effects, NCI-CTAE grade 1 to 4) in 75-100% of patients, including 10-52% grade 3/4 neuropathy with probable dose-toxicity relationship. Platinum compounds (Cisplatin, Carboplatin, Oxaliplatin) are used for the treatment of various solid tumors. Cisplatin and Carboplatin are often used in combination therapy with Vincristine making it difficult to appreciate its relative contribution to peripheral toxicity. Oxaliplatin peripheral neurotoxicity is observed in 37-50% and 3-8% of patients for Common Terminology Criteria for Adverse Effects (CTAE) grade 1/2 and grade 3/4 respectively. Bortezomib is used for preventing antibody mediated in transplantation and for others autoimmune diseases. Thalidomide is used for the treatment of diverse inflammatory conditions such as refractory inflammatory bowel disease, juvenile rheumatoid arthritis and vasculitis and is associated with peripheral neuropathy in 20-40% (Grade > = 2). Clinical features of CIPN are heterogeneous but sensory nerves involvement is prominent. In a very recent study, 23,5% of patients presented with a decrease in sural sensory nerve amplitude several years after exposure of neurotoxic chemotherapy, suggesting a long-term impact with an irreversible reduction of functioning axons. Various molecular and cellular mechanisms have been suggested. Indeed, chemotherapy treatments result in changes to cellular structure and function including alteration in voltage gate ion channels, neurotransmission, organelle function and intracellular signalling. For example, putative mechanisms involved in the development of vincristine-induced peripheral neuropathy are highly multifactorial and depending on disease and patient factors (age, genetic alterations in pharmacokinetic/pharmacodynamic pathways, and susceptibility to hereditary neuropathy). Possible effects of vincristine on tubulin polymerization leading to microtubule destabilization and deficit in axonal transport may be the main mechanisms contributing to the development of vincristine-induced CIPN. Although the individual biological effects of these drugs on cancer cells are relatively well known and studied extensively, the age-related short- and long-term impact on peripheral nerves, prerequisite for the identification of additional preventive or curative approaches, remains incompletely understood.
-Diagnosis and management of pediatric chemotherapy induced neuropathy: Symptoms of neurotoxicity induced by chemotherapy in the peripheral nerve system are often under-recognized and undiagnosed. One major reason has been the lack of specific and sensitive measurement tools for CIPN in the pediatric population. Clinical signs of CIPN are highly heterogenous and include sensory symptoms, including paresthesia (tingling, numbness), dysesthesia, allodynia, hyperalgesia, hypoalgesia or pain (burning/shooting sensation, electric-shock-like). Clinical manifestations could be related to dysfunction of small sensory nerve fibers causing allodynia or hyperpathia. The younger the patient, the less specific the complaints may be. Patients may manifest behavior troubles or refuse to move or to be touched (4). Furthermore, little is known about the long-term impact of CIPN in survivors of childhood cancer in term of quality of life, sleep disorders, psychopathological disorders and learning skills. There is also currently no evidence-based preventive and treatment strategy for CIPN in children. Drugs used in routine clinical practice are those that are efficient in other neuropathic conditions including tricyclic antidepressant, GABAergic agents. However, systemic adverse effects of these treatments are frequent, and the control of the neuropathic pain remains to be optimized. The most commonly used assessment scale for CIPN is the CTCAE, rating 0 to 5 the severity of the sensory or motor neuropathy. CTCAE, although easy to use, displays a poor interobserver agreement and do not provide the specific clinical characteristics of CIPN. In recent years, the Total Neuropathy Scale (TNS) was developed as clinical assessment of peripheral neuropathy in adults and has demonstrated reliability and validity in measuring CIPN in adult cancer patient. The pediatric modified Total Neuropathy Scale (Ped-mTNS) has been developed and tested in population of children (for patient age above 5 years) with cancer with acceptable interrater reliability, test retest reliability and internal consistency. The Ped-mTNS has 5 clinical testing domains: light touch sensation, pin sensibility, vibration sensibility, strength, and deep tendon reflexes. The most widely agreed method for diagnosing small fiber neuropathy is skin biopsy. Intraepidermal nerve fiber density (IENFD) assessment via skin biopsies, which evaluates the epidermal loss of Aδ/C small fiber, cannot be used for follow-up in current practice due to its invasiveness, delay in obtaining results. Furthermore, normal values are lacking in children. Various neurophysiological methods are available in adult for detecting CIPN. Nerve conduction studies (NCS) allows only the assessment of large myelinated nerves and therefore are not suitable for non-myelinated small fiber assessment. In addition, specialized tool are used for the exploration of small non-myelinated fibers including, quantified exploration of the thermal sensitivity (Quantitative Sensory Testing assessing sensory C fibers), laser evoked potentials (PEL assessing sensory A-delta fibers), quantitative Sudomotor Axon Reflex Testing (QSART) assessing small fiber impairment via sudomotor function.
All these tools are not implemented in the pediatric current clinical practice because they are either reserved for research, or technically challenging to perform. or invasive, or poorly reproducible, or lacking normal values. These methods are not accessible to pediatric oncologists and not suitable for follow up patients during chemotherapy.
-Longitudinal assessment of CIPN by the measurement of electrochemical skin conductances (ESC) by SUDOSCAN® (Impeto Medical, Paris, France) Among the small fibers, those innervating the sweat glands degenerate after toxic injury, and are the first to regenerate if the toxic injury is removed. Thus, the fibers innervating the sweat glands could be considered a good marker of small fibers injuries. A new device has been recently developed to quantify the sudomotor function, quickly, non-invasively and quantitatively. The technique is based on the measurement of an electrical signal produced by an electrochemical reaction between the chloride ions present in the sweat and stainless-steel electrodes at which a low current (< 4 V) is applied. The device automatically calculates ESC, expressed in microSiemens (µS), as the ratio between the current generated and the constant direct current stimulus applied to the electrodes. ESC is thought to reflect the innervation of cutaneous sweat glands (autonomic unmyelinated nerve fibres) containing functional chloride channels. In adult, several studies have validated the method and evaluated its diagnostic accuracy to detect small fiber dysfunction in diverse conditions, including diabetes, Familial Transthyretin Amyloid Polyneuropathy, Fabry disease, toxic neuropathy…etc. This method has been compared to reference methods assessing small fiber dysfunction and its diagnostic performance has been evaluated in comparison with the gold standard IENFD. Furthermore, the diagnostic sensitivity for detecting small-fiber neuropathies of ESC measurements was compared to four other neurophysiological tests in 87 adult patients with clinically defined (n = 33) or possible (n = 54) small-fiber neuropathy. The neurophysiological tests, performed at the four extremities (hands and feet), included a quantified study of the thermal sensitivity, with determination of the detection of warm and cold thresholds (WDT and CDT), the recording of evoked potentials by laser stimulation (ELP) and Sympathetic Skin Responses (SSR) and measurement of ESCs. ELPs were the most sensitive test (modified in 56/71 patients with at least one abnormal test (79%)), followed by ESCs (61%), WDT (55%), SSR (41%) and finally the CDT (29%). Thus, in adult, the combination of PEL, assessing sensory A-delta fibers of WDT assessing sensory C fibers, and ESCs, evaluating autonomous C fibers, seems to represent a relevant approach for the diagnosis of SFN. The ELP, although technically efficient, still has some disadvantages, such as the cost of the equipment, the duration of the examination and the technicity of the recordings, contrarily to ESCs that remains a quick test (3 minutes), easy to do and to interpret and can be used as bedside tool.
To date, no research on using this method in children has been published. Very recently normative values have been established in children. Values observed for ESC measurements in healthy children are similar in all group of age and values observed in healthy adults suggesting that sudomotor nerve maturation occurs very early in life. Thus, ESC measurement may be a quick, reproductible, non-invasive and quantitative assessment of small fiber dysfunction in children.
- Being tested
- electrochemical skin conductance measurement
- Keywords
- Chemotherapy induced peripheral neuropathy (CIPN), child, outcome, electrochemical skin conductances (ESC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrochemical skin conductance measurementDiagnostic test
electrochemical skin conductance measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of neuropathy using a ped-mTNS Score
Define as a ped-mTNS score ≥ 5
Measured: 6 months
Diagnosis of neuropathy using electrochemical skin conductance
Define as a mean of electrochemical skin conductance measured at hands and feet < pediatric norms.
Measured: 6 months
Secondary outcomes (2)
Changes in electrochemical skin conductance before clinical signs
Changes in mean of electrochemical skin conductance measured at hands and feet before clinical signs
Measured: 6 months
Changes in electrochemical skin conductance after treatment
Changes in mean of electrochemical skin conductance measured at hands and feet after treatment of neuropathic pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start20 Oct 2020
- Primary completion20 Apr 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de lutte contre les Cancers et les leucémies de l'Enfant et de l'adolescent, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Cyril Gitiaux, MD PhD, Principal investigator, Assistance Public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262778
- Sponsor's protocol ID
- APHP190700
- Other IDs
- 2019-A03044-53
- Acronym
- SUDOPED
- Status last verified
- Oct 2025
- First submitted
- 31 Jan 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kandula T, Farrar MA, Kiernan MC, Krishnan AV, Goldstein D, Horvath L, Grimison P, Boyle F, Baron-Hay S, Park SB. Neurophysiological and clinical outcomes in chemotherapy-induced neuropathy in cancer. Clin Neurophysiol. 2017 Jul;128(7):1166-1175. doi: 10.1016/j.clinph.2017.04.009. Epub 2017 Apr 25.
PubMed 28511129Kandula T, Farrar MA, Cohn RJ, Mizrahi D, Carey K, Johnston K, Kiernan MC, Krishnan AV, Park SB. Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes. JAMA Neurol. 2018 Aug 1;75(8):980-988. doi: 10.1001/jamaneurol.2018.0963.
PubMed 29799906Gilchrist LS, Tanner L. The pediatric-modified total neuropathy score: a reliable and valid measure of chemotherapy-induced peripheral neuropathy in children with non-CNS cancers. Support Care Cancer. 2013 Mar;21(3):847-56. doi: 10.1007/s00520-012-1591-8. Epub 2012 Sep 20.
PubMed 22993026Gibbons CH, Wang N, Freeman R. Capsaicin induces degeneration of cutaneous autonomic nerve fibers. Ann Neurol. 2010 Dec;68(6):888-98. doi: 10.1002/ana.22126.
PubMed 21061393Castro J, Miranda B, Castro I, de Carvalho M, Conceicao I. The diagnostic accuracy of Sudoscan in transthyretin familial amyloid polyneuropathy. Clin Neurophysiol. 2016 May;127(5):2222-7. doi: 10.1016/j.clinph.2016.02.013. Epub 2016 Feb 27.
PubMed 27072093Lefaucheur JP, Wahab A, Plante-Bordeneuve V, Sene D, Menard-Lefaucheur I, Rouie D, Tebbal D, Salhi H, Creange A, Zouari H, Ng Wing Tin S. Diagnosis of small fiber neuropathy: A comparative study of five neurophysiological tests. Neurophysiol Clin. 2015 Dec;45(6):445-55. doi: 10.1016/j.neucli.2015.09.012. Epub 2015 Nov 17.
PubMed 26596193Leclair-Visonneau L, Bosquet T, Magot A, Fayet G, Gras-Le Guen C, Hamel A, Pereon Y. Electrochemical skin conductance for quantitative assessment of sweat function: Normative values in children. Clin Neurophysiol Pract. 2016 Jul 27;1:43-45. doi: 10.1016/j.cnp.2016.07.001. eCollection 2016.
PubMed 30214959
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Electrochemical Skin Conductance Measurement in Paediatric Small Fibre Neuropathy Following Neurotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT04262778
- Acronym / sponsor ID
- SUDOPED / APHP190700
- Keywords
- Chemotherapy induced peripheral neuropathy (CIPN), child, outcome, electrochemical skin conductances (ESC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société Française de lutte contre les Cancers et les leucémies de l'Enfant et de l'adolescent, URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 10 Feb 2020 (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.
The purpose of this study is to determine the diagnostic accuracy of a newly developed tool (Electrochemical Skin Conductances (ESC) measurement) easy-to-perform, non-invasive, highly reproductible and not requiring specific training, to identify pediatric chemotherapy-induced-peripheral-neuropathies (CIPN). CIPN are a frequent (20 to 75% depending on the drug), early and potentially severe long-lasting and dose limiting adverse effect of treatments in immuno-hematology and cancerology. The pathophysiology, the chronology of injury (ie small then large sensory nerve fiber or vice-versa) and the age-related short/long-term impact on peripheral nerves remain largely not understood. Clinical signs of CIPN are highly heterogenous, often under-recognized and include diverse sensory symptoms and pain. Persistent loss of sensation and strength as well as neuropathic pain may have a short/long-term impact in term of functional limitations and quality of life. There is a lack of specific and sensitive measurement tools for CIPN in the pediatric population. Neurophysiological tools (except electro-neuro-myography allowing only the assessment of large myelinated nerves) are not implemented in the pediatric oncology-hematology everyday practice: they are often invasive and/or poorly reproducible, not accessible for "bedside" follow-up, and lacking normative values, thus often dedicated only to research. ESC may provide an early and quantitative assessment of small fiber dysfunction in children, a prerequisite for the identification of additional preventive or curative approaches in CIPN.
Detailed description
Epidemiology and suggested mechanisms involved in pediatric chemotherapy induced neuropathy: Pediatric chemotherapy induced peripheral neuropathy (CIPN) is an early (often occurring within the first three months), potentially severe long-lasting and dose limiting adverse effect of treatment in immuno-hematology and cancerology. It constitutes the second most common cause of dose limitation compromising therapy efficacy after hematological adverse effects. Expanding number of potentially toxic treatment for the peripheral nervous system are currently used. Peripheral nerve toxicity has been mainly described with the platinum-based antineoplastics (particularly oxaliplatin and cisplatin), vinca-alkaloids (particularly vincristine and vinblastine), taxanes (paclitaxel, docetaxel), proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide). Vinca-alkaloids are used for treatment of acute leukemia, lymphoma, various solid tumors and are responsible for neuropathy of any grade (National Cancer Institute Common Terminology Criteria for Adverse Effects, NCI-CTAE grade 1 to 4) in 75-100% of patients, including 10-52% grade 3/4 neuropathy with probable dose-toxicity relationship. Platinum compounds (Cisplatin, Carboplatin, Oxaliplatin) are used for the treatment of various solid tumors. Cisplatin and Carboplatin are often used in combination therapy with Vincristine making it difficult to appreciate its relative contribution to peripheral toxicity. Oxaliplatin peripheral neurotoxicity is observed in 37-50% and 3-8% of patients for Common Terminology Criteria for Adverse Effects (CTAE) grade 1/2 and grade 3/4 respectively. Bortezomib is used for preventing antibody mediated in transplantation and for others autoimmune diseases. Thalidomide is used for the treatment of diverse inflammatory conditions such as refractory inflammatory bowel disease, juvenile rheumatoid arthritis and vasculitis and is associated with peripheral neuropathy in 20-40% (Grade > = 2). Clinical features of CIPN are heterogeneous but sensory nerves involvement is prominent. In a very recent study, 23,5% of patients presented with a decrease in sural sensory nerve amplitude several years after exposure of neurotoxic chemotherapy, suggesting a long-term impact with an irreversible reduction of functioning axons. Various molecular and cellular mechanisms have been suggested. Indeed, chemotherapy treatments result in changes to cellular structure and function including alteration in voltage gate ion channels, neurotransmission, organelle function and intracellular signalling. For example, putative mechanisms involved in the development of vincristine-induced peripheral neuropathy are highly multifactorial and depending on disease and patient factors (age, genetic alterations in pharmacokinetic/pharmacodynamic pathways, and susceptibility to hereditary neuropathy). Possible effects of vincristine on tubulin polymerization leading to microtubule destabilization and deficit in axonal transport may be the main mechanisms contributing to the development of vincristine-induced CIPN. Although the individual biological effects of these drugs on cancer cells are relatively well known and studied extensively, the age-related short- and long-term impact on peripheral nerves, prerequisite for the identification of additional preventive or curative approaches, remains incompletely understood.
-Diagnosis and management of pediatric chemotherapy induced neuropathy: Symptoms of neurotoxicity induced by chemotherapy in the peripheral nerve system are often under-recognized and undiagnosed. One major reason has been the lack of specific and sensitive measurement tools for CIPN in the pediatric population. Clinical signs of CIPN are highly heterogenous and include sensory symptoms, including paresthesia (tingling, numbness), dysesthesia, allodynia, hyperalgesia, hypoalgesia or pain (burning/shooting sensation, electric-shock-like). Clinical manifestations could be related to dysfunction of small sensory nerve fibers causing allodynia or hyperpathia. The younger the patient, the less specific the complaints may be. Patients may manifest behavior troubles or refuse to move or to be touched (4). Furthermore, little is known about the long-term impact of CIPN in survivors of childhood cancer in term of quality of life, sleep disorders, psychopathological disorders and learning skills. There is also currently no evidence-based preventive and treatment strategy for CIPN in children. Drugs used in routine clinical practice are those that are efficient in other neuropathic conditions including tricyclic antidepressant, GABAergic agents. However, systemic adverse effects of these treatments are frequent, and the control of the neuropathic pain remains to be optimized. The most commonly used assessment scale for CIPN is the CTCAE, rating 0 to 5 the severity of the sensory or motor neuropathy. CTCAE, although easy to use, displays a poor interobserver agreement and do not provide the specific clinical characteristics of CIPN. In recent years, the Total Neuropathy Scale (TNS) was developed as clinical assessment of peripheral neuropathy in adults and has demonstrated reliability and validity in measuring CIPN in adult cancer patient. The pediatric modified Total Neuropathy Scale (Ped-mTNS) has been developed and tested in population of children (for patient age above 5 years) with cancer with acceptable interrater reliability, test retest reliability and internal consistency. The Ped-mTNS has 5 clinical testing domains: light touch sensation, pin sensibility, vibration sensibility, strength, and deep tendon reflexes. The most widely agreed method for diagnosing small fiber neuropathy is skin biopsy. Intraepidermal nerve fiber density (IENFD) assessment via skin biopsies, which evaluates the epidermal loss of Aδ/C small fiber, cannot be used for follow-up in current practice due to its invasiveness, delay in obtaining results. Furthermore, normal values are lacking in children. Various neurophysiological methods are available in adult for detecting CIPN. Nerve conduction studies (NCS) allows only the assessment of large myelinated nerves and therefore are not suitable for non-myelinated small fiber assessment. In addition, specialized tool are used for the exploration of small non-myelinated fibers including, quantified exploration of the thermal sensitivity (Quantitative Sensory Testing assessing sensory C fibers), laser evoked potentials (PEL assessing sensory A-delta fibers), quantitative Sudomotor Axon Reflex Testing (QSART) assessing small fiber impairment via sudomotor function.
All these tools are not implemented in the pediatric current clinical practice because they are either reserved for research, or technically challenging to perform. or invasive, or poorly reproducible, or lacking normal values. These methods are not accessible to pediatric oncologists and not suitable for follow up patients during chemotherapy.
-Longitudinal assessment of CIPN by the measurement of electrochemical skin conductances (ESC) by SUDOSCAN® (Impeto Medical, Paris, France) Among the small fibers, those innervating the sweat glands degenerate after toxic injury, and are the first to regenerate if the toxic injury is removed. Thus, the fibers innervating the sweat glands could be considered a good marker of small fibers injuries. A new device has been recently developed to quantify the sudomotor function, quickly, non-invasively and quantitatively. The technique is based on the measurement of an electrical signal produced by an electrochemical reaction between the chloride ions present in the sweat and stainless-steel electrodes at which a low current (< 4 V) is applied. The device automatically calculates ESC, expressed in microSiemens (µS), as the ratio between the current generated and the constant direct current stimulus applied to the electrodes. ESC is thought to reflect the innervation of cutaneous sweat glands (autonomic unmyelinated nerve fibres) containing functional chloride channels. In adult, several studies have validated the method and evaluated its diagnostic accuracy to detect small fiber dysfunction in diverse conditions, including diabetes, Familial Transthyretin Amyloid Polyneuropathy, Fabry disease, toxic neuropathy…etc. This method has been compared to reference methods assessing small fiber dysfunction and its diagnostic performance has been evaluated in comparison with the gold standard IENFD. Furthermore, the diagnostic sensitivity for detecting small-fiber neuropathies of ESC measurements was compared to four other neurophysiological tests in 87 adult patients with clinically defined (n = 33) or possible (n = 54) small-fiber neuropathy. The neurophysiological tests, performed at the four extremities (hands and feet), included a quantified study of the thermal sensitivity, with determination of the detection of warm and cold thresholds (WDT and CDT), the recording of evoked potentials by laser stimulation (ELP) and Sympathetic Skin Responses (SSR) and measurement of ESCs. ELPs were the most sensitive test (modified in 56/71 patients with at least one abnormal test (79%)), followed by ESCs (61%), WDT (55%), SSR (41%) and finally the CDT (29%). Thus, in adult, the combination of PEL, assessing sensory A-delta fibers of WDT assessing sensory C fibers, and ESCs, evaluating autonomous C fibers, seems to represent a relevant approach for the diagnosis of SFN. The ELP, although technically efficient, still has some disadvantages, such as the cost of the equipment, the duration of the examination and the technicity of the recordings, contrarily to ESCs that remains a quick test (3 minutes), easy to do and to interpret and can be used as bedside tool.
To date, no research on using this method in children has been published. Very recently normative values have been established in children. Values observed for ESC measurements in healthy children are similar in all group of age and values observed in healthy adults suggesting that sudomotor nerve maturation occurs very early in life. Thus, ESC measurement may be a quick, reproductible, non-invasive and quantitative assessment of small fiber dysfunction in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child receiving a Potentially Neurotoxic Chemotherapy
Key inclusion criteria (3 listed)
- aged 5-17 years
- initiating a potentially neurotoxic chemotherapy alkaloids (vincristine vinblastine, vinorelbine), Platinum compounds (oxaliplatine, cisplatine, carboplatine), proteasome inhibitors (bortezomib), Thalidomide derivatives, taxanes (such as taxol or taxotere), antiCD30 (brentuximab)
- Information of the legal representative of the patient Affiliated to social security regime or an equivalent system
Key exclusion criteria (4 listed)
- history of peripheric neuropathy
- current antiepileptic medications or other treatment for neurogenic pain (tegretol, neurontin, lyrica, laroxyl, rivotril,… etc)
- distal skin lesions that do not allow electrochemical skin conductance measurement
- child not able to stand during the time of examination
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 |
|---|---|---|
| electrochemical skin conductance measurementelectrochemical skin conductance measurement | Diagnostic test | – |
Primary outcome
Diagnosis of neuropathy using a ped-mTNS Score
Time frame: 6 months
Define as a ped-mTNS score ≥ 5
Diagnosis of neuropathy using electrochemical skin conductance
Time frame: 6 months
Define as a mean of electrochemical skin conductance measured at hands and feet < pediatric norms.
2 secondary outcomes
Changes in electrochemical skin conductance before clinical signs
Time frame: 6 months
Changes in electrochemical skin conductance after treatment
Time frame: 6 months
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 20 Nov 2025.
- Background: PubMed 28511129Kandula T, Farrar MA, Kiernan MC, Krishnan AV, Goldstein D, Horvath L, Grimison P, Boyle F, Baron-Hay S, Park SB. Neurophysiological and clinical outcomes in chemotherapy-induced neuropathy in cancer. Clin Neurophysiol. 2017 Jul;128(7):1166-1175. doi: 10.1016/j.clinph.2017.04.009. Epub 2017 Apr 25.
- Background: PubMed 29799906Kandula T, Farrar MA, Cohn RJ, Mizrahi D, Carey K, Johnston K, Kiernan MC, Krishnan AV, Park SB. Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes. JAMA Neurol. 2018 Aug 1;75(8):980-988. doi: 10.1001/jamaneurol.2018.0963.
- Background: PubMed 22993026Gilchrist LS, Tanner L. The pediatric-modified total neuropathy score: a reliable and valid measure of chemotherapy-induced peripheral neuropathy in children with non-CNS cancers. Support Care Cancer. 2013 Mar;21(3):847-56. doi: 10.1007/s00520-012-1591-8. Epub 2012 Sep 20.
- Background: PubMed 21061393Gibbons CH, Wang N, Freeman R. Capsaicin induces degeneration of cutaneous autonomic nerve fibers. Ann Neurol. 2010 Dec;68(6):888-98. doi: 10.1002/ana.22126.
- Background: PubMed 27072093Castro J, Miranda B, Castro I, de Carvalho M, Conceicao I. The diagnostic accuracy of Sudoscan in transthyretin familial amyloid polyneuropathy. Clin Neurophysiol. 2016 May;127(5):2222-7. doi: 10.1016/j.clinph.2016.02.013. Epub 2016 Feb 27.
- Background: PubMed 26596193Lefaucheur JP, Wahab A, Plante-Bordeneuve V, Sene D, Menard-Lefaucheur I, Rouie D, Tebbal D, Salhi H, Creange A, Zouari H, Ng Wing Tin S. Diagnosis of small fiber neuropathy: A comparative study of five neurophysiological tests. Neurophysiol Clin. 2015 Dec;45(6):445-55. doi: 10.1016/j.neucli.2015.09.012. Epub 2015 Nov 17.
- Background: PubMed 30214959Leclair-Visonneau L, Bosquet T, Magot A, Fayet G, Gras-Le Guen C, Hamel A, Pereon Y. Electrochemical skin conductance for quantitative assessment of sweat function: Normative values in children. Clin Neurophysiol Pract. 2016 Jul 27;1:43-45. doi: 10.1016/j.cnp.2016.07.001. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Cyril Gitiaux, MD PhD principal investigator
Assistance Public Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 4 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 20 Nov 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?
Diagnosis of neuropathy using a ped-mTNS Score (time frame: 6 months). The study lists 2 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 NCT04262778, which also lists 7 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 20 Nov 2025.