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

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: Cancer
• Intervention / Treatment: Device: Mediracer® NCS

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland
    • Oulu University Hospital

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oulu University Hospital

Study record dates

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: CIPN, NCS
• Additional Relevant MeSH Terms: Nervous System Diseases; Chemically-Induced Disorders; Poisoning; Neurotoxicity Syndromes
• 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