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

Oulu University Hospital12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cancer

Interventions

Mediracer® NCSDEVICE

A point-of-care, hand-held nerve conduction device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent 2. Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen \[FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin\] 3. Age \>18y 4. ECOG 0-2 5. Patient compliant with the study procedures Exclusion Criteria: 1. Patient not fit/suitable for aforementioned chemotherapy regimen at baseline 2. Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves 3. General vulnerability affecting the participation in the trial

Locations (1)

Oulu University Hospital

Oulu, Finland

Outcomes

Primary Outcomes

Nerve conductivity

Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS

Time frame: 6 weeks

Nerve conductivity

Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS

Time frame: 12 weeks

Nerve conductivity

Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS

Time frame: 18 weeks

Nerve conductivity

Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS

Time frame: 24 weeks

Neuropathy related pain

Neuropathy related pain according to NPSI-assessment

Time frame: 6 weeks

Neuropathy related pain

Neuropathy related pain according to NPSI-assessment

Time frame: 12 weeks

Neuropathy related pain

Neuropathy related pain according to NPSI-assessment

Time frame: 18 weeks

Neuropathy related pain

Neuropathy related pain according to NPSI-assessment

Time frame: 24 weeks

Chemotherapy induced peripheral neuropathy (CIPN)

CIPN assessed by EORTC QLQ-CIPN20 questionnaire

Time frame: 6 weeks

Chemotherapy induced peripheral neuropathy (CIPN)

Data from ClinicalTrials.gov

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