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Completed

NCT Number: NCT04778878

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital

Oulu, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediracer® NCS

Device

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

Primary outcomes

  1. Nerve conductivity

    Time frame: 6 weeks

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

  2. Nerve conductivity

    Time frame: 12 weeks

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

  3. Nerve conductivity

    Time frame: 18 weeks

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

  4. Nerve conductivity

    Time frame: 24 weeks

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

  5. Neuropathy related pain

    Time frame: 6 weeks

    Neuropathy related pain according to NPSI-assessment

  6. Neuropathy related pain

    Time frame: 12 weeks

    Neuropathy related pain according to NPSI-assessment

  7. Neuropathy related pain

    Time frame: 18 weeks

    Neuropathy related pain according to NPSI-assessment

  8. Neuropathy related pain

    Time frame: 24 weeks

    Neuropathy related pain according to NPSI-assessment

  9. Chemotherapy induced peripheral neuropathy (CIPN)

    Time frame: 6 weeks

    CIPN assessed by EORTC QLQ-CIPN20 questionnaire

  10. Chemotherapy induced peripheral neuropathy (CIPN)

    Time frame: 12 weeks

    CIPN assessed by EORTC QLQ-CIPN20 questionnaire

  11. Chemotherapy induced peripheral neuropathy (CIPN)

    Time frame: 18 weeks

    CIPN assessed by EORTC QLQ-CIPN20 questionnaire

  12. Chemotherapy induced peripheral neuropathy (CIPN)

    Time frame: 24 weeks

    CIPN assessed by EORTC QLQ-CIPN20 questionnaire

  13. Frequency of CIPN by CTCAE

    Time frame: 6 weeks

    Frequency of CIPN by CTCAE

  14. Frequency of CIPN by CTCAE

    Time frame: 12 weeks

    Frequency of CIPN by CTCAE

  15. Frequency of CIPN by CTCAE

    Time frame: 18 weeks

    Frequency of CIPN by CTCAE

  16. Frequency of CIPN by CTCAE

    Time frame: 24 weeks

    Frequency of CIPN by CTCAE

Sponsors and collaborators

Lead sponsor

Oulu University Hospital

Other

Registry information

Acronym: APPS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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