International CIPN Assessment and Validation Study

NCT04633655 | Recruiting

• 1 other identifier: ICAVS
• Study Type: observational
• Target: 1,000
• Locations: 15 countries
• Sites: 29

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Quality of Life

Keywords

clinimetrics; biomarker; PRO; outcome measures

Outcome Measures

Primary Outcomes (9)

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade

  NCI-CTC v.5 sensory and motor (changes from base line to end treatment of a 0-5 score)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in PRO-CTCAE

  PRO-CTCAE (changes from base line to end treatment of a 0-5 score for each item)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS)

  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).

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN scale

  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)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© scale

  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)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© scale

  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)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© scale

  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)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC scale

  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)

  5 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ scale

  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)

  5 YEARS

Secondary Outcomes (6)

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN15 scale

  7 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSc© scale

  7 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in nerve conduction studies

  7 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in Quantitative sensory testing (QST)

  7 YEARS

• Chemotherapy-induced peripheral neurotoxicity as assessed by change in neurofilament light chain (NfL) levels

  7 YEARS

Study Arms (1)

Patients who are receiving a neurotoxic chemotherapy

List of neurotoxic drugs eligible for enrolment * Platinum drugs * Taxanes * Vinca alkaloids * Epothilones * Proteasome inhibitors * Thalidomide * Vedotin-based drugs * checkpoint inhibitors * Any combination of the aforementioned drugs

Other: outcome measures for CIPN testing

Interventions

outcome measures for CIPN testing OTHER

questionnaires administration, physician based scales for CIPN data collection

Patients who are receiving a neurotoxic chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients candidated to neurotoxic chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (30)

Birmingham School of Nursing, University of Alabama

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

NOT YET RECRUITING

JHU

Baltimore, Maryland, 21224, United States

NOT YET RECRUITING

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Columbia University Irving Medical Center

New York, New York, 10027, United States

NOT YET RECRUITING

Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division

Columbus, Ohio, 43220, United States

NOT YET RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, Pennsylvania, 03756, United States

NOT YET RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05445, United States

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, 20900, Italy

RECRUITING

Ospedale Valduce

Como, 22063, Italy

WITHDRAWN

Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

A.O.U. Policlinico "G. Martino"

Messina, Italy

NOT YET RECRUITING

Padova Hospital

Padua, 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for neurofilament light chain detection

MeSH Terms

Interventions

Outcome Assessment, Health Care

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• GUIDO CAVALETTI, MD

  University of Milano Bicocca

  STUDY CHAIR

• PAOLA ALBERTI, MD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GUIDO CAVALETTI, MD

CONTACT

+ 39 02 6448 8039; guido.cavaletti@unimib.it

PAOLA ALBERTI, MD, PhD

CONTACT

+39 02 6448 8154; paola.alberti@unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: November 18, 2020
• Study Start: June 8, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1); BR (1); GR (2); AU (1); ES (1); DE (1); PT (1); DK (1); CH (1); KR (1); US (8); IT (6); CA (1); FR (2); KE (1)