Actively Recruiting

Age: 18Years +
All Genders
NCT04633655

International CIPN Assessment and Validation Study

Led by University of Milano Bicocca · Updated on 2025-07-25

1000

Participants Needed

30

Research Sites

290 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

International CIPN Assessment and Validation Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Candidates for neurotoxic chemotherapy at doses expected to cause nerve damage
  • Male or female aged 18 years or older
  • Able to provide signed informed consent
  • Willing to complete all study activities and follow-up visits
  • Karnofsky performance score of 70 or higher
Not Eligible

You will not qualify if you...

  • Poor prognosis making completion of chemotherapy unlikely
  • Neurologic conditions interfering with assessments (e.g., brain tumor, metastases)
  • Severe depression complicating assessments
  • Chronic use of antiepileptic drugs, antidepressants, or major analgesics unless stable for 3 months
  • Use of preventive interventions like antioxidants or cryotherapy
  • Current use of medications known to cause peripheral nerve toxicity besides chemotherapy
  • Any other condition reducing ability to provide satisfactory data
  • Previous treatment with neurotoxic chemotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

Birmingham School of Nursing, University of Alabama

Birmingham, Alabama, United States, 35294

Not Yet Recruiting

2

Northside Hospital

Atlanta, Georgia, United States, 30342

Not Yet Recruiting

3

JHU

Baltimore, Maryland, United States, 21224

Not Yet Recruiting

4

University of Michigan School of Nursing

Ann Arbor, Michigan, United States, 48109

Not Yet Recruiting

5

Columbia University Irving Medical Center

New York, New York, United States, 10027

Not Yet Recruiting

6

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

Columbus, Ohio, United States, 43220

Not Yet Recruiting

7

Dartmouth-Hitchcock Medical Center

Lebanon, Pennsylvania, United States, 03756

Not Yet Recruiting

8

University of Vermont Medical Center

Burlington, Vermont, United States, 05445

Not Yet Recruiting

9

Brain and Mind Center

Sydney, Australia

Not Yet Recruiting

10

Dept. of Neurology, Medical University of Vienna

Vienna, Austria

Not Yet Recruiting

11

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

Not Yet Recruiting

12

Clínica AMO

Salvador, Brazil

Not Yet Recruiting

13

The Ottawa Hospital

Ottawa, Canada

Not Yet Recruiting

14

Aarhus University Hospital

Aarhus, Denmark

Withdrawn

15

Hôpital Percy

Clamart, France

Not Yet Recruiting

16

CHU Dupuytren

Limoges, France

Not Yet Recruiting

17

Center for Molecular Medicine

Cologne, Germany

Not Yet Recruiting

18

University of Larissa

Larissa, Greece

Not Yet Recruiting

19

"Saint Andrew's" State General Hospital

Pátrai, Greece

Actively Recruiting

20

San Gerardo Hospital

Monza, Mb, Italy, 20900

Actively Recruiting

21

Ospedale Valduce

Como, Italy, 22063

Withdrawn

22

Ospedale Policlinico San Martino

Genova, Italy

Actively Recruiting

23

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

Messina, Italy

Not Yet Recruiting

24

Padova Hospital

Padova, Italy

Not Yet Recruiting

25

Azienda Ospedaliera Universitaria

Verona, Italy

Not Yet Recruiting

26

Medical Oncoloy Unit - University of Nairobi

Nairobi, Kenya

Not Yet Recruiting

27

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Portugal

Not Yet Recruiting

28

Dong-A University - Internal Medicine Dept.

Busan, South Korea

Actively Recruiting

29

Hospital Universitari de Bellvitge-ICO L'Hospitalet

Barcelona, Spain

Actively Recruiting

30

University of Basel - Department of Sport, Exercise and Health

Basel, Switzerland

Not Yet Recruiting

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Research Team

G

GUIDO CAVALETTI, MD

CONTACT

P

PAOLA ALBERTI, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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