Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.

Official Title
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Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device

Conditions
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Cancer

Intervention / Treatment
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* Device: Mediracer® NCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen [FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin] Age >18y ECOG 0-2 Patient compliant with the study procedures Exclusion Criteria: Patient not fit/suitable for aforementioned chemotherapy regimen at baseline Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves General vulnerability affecting the participation in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mediracer® NCS|A point-of-care, hand-held nerve conduction device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conductivity | Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS | 6 weeks | 
| Nerve conductivity | Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS | 12 weeks | 
| Nerve conductivity | Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS | 18 weeks | 
| Nerve conductivity | Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS | 24 weeks | 
| Neuropathy related pain | Neuropathy related pain according to NPSI-assessment | 6 weeks | 
| Neuropathy related pain | Neuropathy related pain according to NPSI-assessment | 12 weeks | 
| Neuropathy related pain | Neuropathy related pain according to NPSI-assessment | 18 weeks | 
| Neuropathy related pain | Neuropathy related pain according to NPSI-assessment | 24 weeks | 
| Chemotherapy induced peripheral neuropathy (CIPN) | CIPN assessed by EORTC QLQ-CIPN20 questionnaire | 6 weeks | 
| Chemotherapy induced peripheral neuropathy (CIPN) | CIPN assessed by EORTC QLQ-CIPN20 questionnaire | 12 weeks | 
| Chemotherapy induced peripheral neuropathy (CIPN) | CIPN assessed by EORTC QLQ-CIPN20 questionnaire | 18 weeks | 
| Chemotherapy induced peripheral neuropathy (CIPN) | CIPN assessed by EORTC QLQ-CIPN20 questionnaire | 24 weeks | 
| Frequency of CIPN by CTCAE | Frequency of CIPN by CTCAE | 6 weeks | 
| Frequency of CIPN by CTCAE | Frequency of CIPN by CTCAE | 12 weeks | 
| Frequency of CIPN by CTCAE | Frequency of CIPN by CTCAE | 18 weeks | 
| Frequency of CIPN by CTCAE | Frequency of CIPN by CTCAE | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIPN, NCS