International CIPN Assessment and Validation Study

Recruiting now

Conditions studied: Chemotherapy-induced Peripheral Neuropathy, Quality of Life

In brief

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.

Key facts

Study ID: NCT04633655
Run by: University of Milano Bicocca
People needed: 1000
Starts: 2020-06-08
Expected to finish: 2025-12-31
Last updated by the study team: 2025-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).
Male and female subjects who are 18 years of age or older.
Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
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:
Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
Severe depression that in the opinion of the Investigator would complicate the assessments.
Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
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).
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.
Previous neurotoxic chemotherapy.

Where it is running

San Gerardo Hospital — Monza, Mb, Italy (enrolling)
"Saint Andrew's" State General Hospital — Pátrai, Greece (enrolling)
Dong-A University - Internal Medicine Dept. — Busan, South Korea (enrolling)
Hospital Universitari de Bellvitge-ICO L'Hospitalet — Barcelona, Spain (enrolling)
Ospedale Policlinico San Martino — Genova, Italy (enrolling)
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division — Columbus, Ohio, United States
Dartmouth-Hitchcock Medical Center — Lebanon, Pennsylvania, United States
University of Vermont Medical Center — Burlington, Vermont, United States
Brain and Mind Center — Sydney, Australia
Dept. of Neurology, Medical University of Vienna — Vienna, Austria
International Centre for Diarrhoeal Disease Research — Dhaka, Bangladesh
Clínica AMO — Salvador, Brazil
The Ottawa Hospital — Ottawa, Canada
Aarhus University Hospital — Aarhus, Denmark
Hôpital Percy — Clamart, France
CHU Dupuytren — Limoges, France
Center for Molecular Medicine — Cologne, Germany
University of Larissa — Larissa, Greece
Ospedale Valduce — Como, Italy
A.O.U. Policlinico "G. Martino" — Messina, Italy
Padova Hospital — Padova, Italy
Azienda Ospedaliera Universitaria — Verona, Italy
Medical Oncoloy Unit - University of Nairobi — Nairobi, Kenya
Centro Hospitalar Vila Nova de Gaia/Espinho — Vila Nova de Gaia, Portugal
Birmingham School of Nursing, University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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