International CIPN Assessment and Validation Study

NCT04633655 · tracked via the Priya Life Science Brazil tracker

Sponsor

University of Milano Bicocca

Phase

Observational

Started

2020-06-08

Last updated

2025-07-25

Condition(s) studied

Chemotherapy-induced Peripheral NeuropathyQuality of Life

Investigational drug(s) / intervention(s)

outcome measures for CIPN testing

outcome measures for CIPN testing: questionnaires administration, physician based scales for CIPN data collection

Study summary

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study: 1. Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1). 2. Male and female subjects who are 18 years of age or older. 3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry. 4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol. 5. Subjects must have a Karnofsky performance score greater than or equal to 70. Exclusion Criteria Subjects presenting with any of the following will not be included in the study: 1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment. 2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments. 3. Severe depression that in the opinion of the Investigator would complicate the assessments. 4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry. 5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure). 6. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g. metronidazole, isoniazid, amiodarone, antiretroviral medications). 7. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study. 8. Previous neurotoxic chemotherapy.

Primary outcome measure(s)

Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade — 5 YEARS
NCI-CTC v.5 sensory and motor (changes from base line to end treatment of a 0-5 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in PRO-CTCAE — 5 YEARS
PRO-CTCAE (changes from base line to end treatment of a 0-5 score for each item)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS) — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS) (0-10 score).
Chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN scale — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN (changes from base line to end treatment of a 0-10 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© scale — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© (changes from base line to end treatment of a 0-100 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© scale — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© (changes from base line to end treatment of a 0-44 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© scale — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© (changes from base line to end treatment of a 0-20 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC scale — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC (changes from base line to end treatment of a 0-10 score)
Chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ scale — 5 YEARS
difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ (changes from base line to end treatment of number of symptoms: this is a yes/no questionnaire for the presence of neuropathy symptoms)

Trial sites (30)

Facility	City	Region	Status
Birmingham School of Nursing, University of Alabama	Birmingham	Alabama	Not Yet Recruiting
Northside Hospital	Atlanta	Georgia	Not Yet Recruiting
JHU	Baltimore	Maryland	Not Yet Recruiting
University of Michigan School of Nursing	Ann Arbor	Michigan	Not Yet Recruiting
Columbia University Irving Medical Center	New York	New York	Not Yet Recruiting
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division	Columbus	Ohio	Not Yet Recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	Pennsylvania	Not Yet Recruiting
University of Vermont Medical Center	Burlington	Vermont	Not Yet Recruiting
Brain and Mind Center	Sydney	Australia	Not Yet Recruiting
Dept. of Neurology, Medical University of Vienna	Vienna	Austria	Not Yet Recruiting
International Centre for Diarrhoeal Disease Research	Dhaka	Bangladesh	Not Yet Recruiting
Clínica AMO	Salvador	Brazil	Not Yet Recruiting
The Ottawa Hospital	Ottawa	Canada	Not Yet Recruiting
Aarhus University Hospital	Aarhus	Denmark	Withdrawn
Hôpital Percy	Clamart	France	Not Yet Recruiting
CHU Dupuytren	Limoges	France	Not Yet Recruiting
Center for Molecular Medicine	Cologne	Germany	Not Yet Recruiting
University of Larissa	Larissa	Greece	Not Yet Recruiting
"Saint Andrew's" State General Hospital	Pátrai	Greece	Recruiting
San Gerardo Hospital	Monza	Mb	Recruiting
Ospedale Valduce	Como	Italy	Withdrawn
Ospedale Policlinico San Martino	Genova	Italy	Recruiting
A.O.U. Policlinico "G. Martino"	Messina	Italy	Not Yet Recruiting
Padova Hospital	Padova	Italy	Not Yet Recruiting
Azienda Ospedaliera Universitaria	Verona	Italy	Not Yet Recruiting
Medical Oncoloy Unit - University of Nairobi	Nairobi	Kenya	Not Yet Recruiting
Centro Hospitalar Vila Nova de Gaia/Espinho	Vila Nova de Gaia	Portugal	Not Yet Recruiting
Dong-A University - Internal Medicine Dept.	Busan	South Korea	Recruiting
Hospital Universitari de Bellvitge-ICO L'Hospitalet	Barcelona	Spain	Recruiting
University of Basel - Department of Sport, Exercise and Health	Basel	Switzerland	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04633655 on ClinicalTrials.gov ↗ ← All trials in Brazil