CompletedNot Applicable

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

Finland12 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Nerve conductivity

Timeframe: 6 weeks

Nerve conductivity

Timeframe: 12 weeks

Nerve conductivity

Timeframe: 18 weeks

Nerve conductivity

Timeframe: 24 weeks

Neuropathy related pain

Timeframe: 6 weeks

Neuropathy related pain

Timeframe: 12 weeks

Neuropathy related pain

Timeframe: 18 weeks

Neuropathy related pain

Timeframe: 24 weeks

Chemotherapy induced peripheral neuropathy (CIPN)

Timeframe: 6 weeks

Trial details

NCT IDNCT04778878

SponsorOulu University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-28

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