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

Cancer Clinical Trial

— APPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04778878
• Other study ID #: 48/2019
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neurotoxicity Syndromes

Intervention

Device:
• Mediracer® NCS
A point-of-care, hand-held nerve conduction device

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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