Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device
Completed
- Conditions
- Cancer
- Registration Number
- NCT04778878
- Lead Sponsor
- Oulu University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Nerve conductivity 24 weeks Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Neuropathy related pain 24 weeks Neuropathy related pain according to NPSI-assessment
Chemotherapy induced peripheral neuropathy (CIPN) 24 weeks CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Frequency of CIPN by CTCAE 24 weeks Frequency of CIPN by CTCAE
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland
Oulu University Hospital🇫🇮Oulu, Finland