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

August 22, 2025 updated by: Jussi Koivunen, Oulu University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients receiving neurotoxic chemotherapy (oxaliplatin, vincristine, or docetaxel) as cancer treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve conductivity
Time Frame: 6 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
6 weeks
Nerve conductivity
Time Frame: 12 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
12 weeks
Nerve conductivity
Time Frame: 18 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
18 weeks
Nerve conductivity
Time Frame: 24 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
24 weeks
Neuropathy related pain
Time Frame: 6 weeks
Neuropathy related pain according to NPSI-assessment
6 weeks
Neuropathy related pain
Time Frame: 12 weeks
Neuropathy related pain according to NPSI-assessment
12 weeks
Neuropathy related pain
Time Frame: 18 weeks
Neuropathy related pain according to NPSI-assessment
18 weeks
Neuropathy related pain
Time Frame: 24 weeks
Neuropathy related pain according to NPSI-assessment
24 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
Time Frame: 6 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
6 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
Time Frame: 12 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
12 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
Time Frame: 18 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
18 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
Time Frame: 24 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
24 weeks
Frequency of CIPN by CTCAE
Time Frame: 6 weeks
Frequency of CIPN by CTCAE
6 weeks
Frequency of CIPN by CTCAE
Time Frame: 12 weeks
Frequency of CIPN by CTCAE
12 weeks
Frequency of CIPN by CTCAE
Time Frame: 18 weeks
Frequency of CIPN by CTCAE
18 weeks
Frequency of CIPN by CTCAE
Time Frame: 24 weeks
Frequency of CIPN by CTCAE
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oulu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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