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Clinical Trials in Italy / NCT04633655
Recruiting Observational

International CIPN Assessment and Validation Study

NCT04633655 · tracked via the Priya Life Science Italy 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
No
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)

FacilityCityRegionStatus
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 Italy