Cancer
Conditions
Keywords
CIPN, NCS
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.
Interventions
DEVICEMediracer® NCS
A point-of-care, hand-held nerve conduction device
Sponsors
Oulu University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve conductivity | 6 weeks | Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS |
| Neuropathy related pain | 6 weeks | Neuropathy related pain according to NPSI-assessment |
| Chemotherapy induced peripheral neuropathy (CIPN) | 6 weeks | CIPN assessed by EORTC QLQ-CIPN20 questionnaire |
| Frequency of CIPN by CTCAE | 6 weeks | Frequency of CIPN by CTCAE |
Countries
Finland
Outcome results
None listed