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Diagnostic of Chemotherapy Induced Neuropathy in Children (SUDOPED)

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ClinicalTrials.gov Identifier: NCT04262778
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Société Française de lutte contre les cancers et leucémies de l'enfant et de l'adolescent (SFCE)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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). 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.

Condition or disease Intervention/treatment
Chemotherapy-induced Peripheral Neuropathy Diagnostic Test: electrochemical skin conductance measurement

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Accuracy of Electrochemical Skin Conductance Measurement in Paediatric Small Fibre Neuropathy Following Neurotoxic Chemotherapy
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: electrochemical skin conductance measurement
    electrochemical skin conductance measurement


Primary Outcome Measures :
  1. Diagnosis of neuropathy using a ped-mTNS Score [ Time Frame: 6 months ]
    Define as a ped-mTNS score > 5

  2. 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.


Secondary Outcome Measures :
  1. Changes in electrochemical skin conductance before clinical signs [ Time Frame: 6 months ]
    Changes in mean of electrochemical skin conductance measured at hands and feet before clinical signs

  2. Changes in electrochemical skin conductance after treatment [ Time Frame: 6 months ]
    Changes in mean of electrochemical skin conductance measured at hands and feet after treatment of neuropathic pain



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Child receiving a Potentially Neurotoxic Chemotherapy
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262778


Contacts
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Contact: Cyril Gitiaux, MD PhD +33 1 44 49 58 36 cyril.gitiaux@aphp.fr
Contact: Nelly Briand, PhD + 33 1 44 38 18 62 nelly.briand@ahp.fr

Locations
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France
Necker- enfants maladies hospital Recruiting
Paris, France, 75015
Contact: Cyril Gitiaux, MD PhD    +33 1 44 49 58 36    cyril.gitiaux@aphp.fr   
Contact: Céline Gréco, MD PhD    +33 1 42 19 27 28    celine.greco@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société Française de lutte contre les cancers et leucémies de l'enfant et de l'adolescent (SFCE)
Investigators
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Principal Investigator: Cyril Gitiaux, MD PhD Assistance Public Hôpitaux de Paris
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04262778    
Other Study ID Numbers: APHP190700
2019-A03044-53 ( Registry Identifier: ID-RCB )
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chemotherapy induced peripheral neuropathy (CIPN)
child
outcome
electrochemical skin conductances (ESC)
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases