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

• Conditions: Cancer

• Registration Number: NCT04778878
• Lead Sponsor: Oulu University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2021-02-23
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-05-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland