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Chemotherapy-induced Peripheral NeuropathyICAVSNCT04633655

International CIPN Assessment and Validation Study

An observational study of Chemotherapy-induced Peripheral Neuropathy and Quality of Life, run by University of Milano Bicocca at 30 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
outcome measures for CIPN testing
How many people
1,000 participants
Where
30 sitesin 16 countries
Study dates
8 Jun 2020to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients candidated to neurotoxic chemotherapy

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

30 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

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

30 sites in 16 countries

United States8 sites, 8 recruiting

  • University of Michigan School of Nursing

    Ann Arbor, Michigan, 48109

    Ellen Lavoie Smith, PhD, 734-936-1267, ellenls@med.umich.edu

    Not yet recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Guilherme Cantuaria, MD, PhD, Margaret.Ferreira@northside.com

    Margaret Ferreira

    Not yet recruiting

  • JHU

    Baltimore, Maryland, 21224

    Khoshnoodi Mohammad, MD, 410-502-7683, mkhoshn1@jhmi.edu

    Not yet recruiting

  • Birmingham School of Nursing, University of Alabama

    Birmingham, Alabama, 35294

    Ellen M. Lavoie Smith, PhD, esmith3@uab.edu

    Not yet recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05445

    Noah Kolb, MD, 978-886-2828, Noah.kolb@uvmhealth.org

    Not yet recruiting

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

    Columbus, Ohio, 43220

    Maryam Lustberg, MD, MPH, 410-299-1044, maryam.lustberg@osumc.edu

    Not yet recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, Pennsylvania, 03756

    Victoria H Lawson, MD, 603-650-5104, Victoria.H.Lawson@dartmouth.edu

    Not yet recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10027

    Thomas III H Brannagan, MD, 212-305-0405, tb2325@cumc.columbia.edu

    Not yet recruiting

Other trials in United States

Italy6 sites, 5 recruiting

  • Ospedale Valduce

    Como, 22063

    Withdrawn

  • Ospedale Policlinico San Martino

    Genova

    ANGELO SCHENONE, + 39 049 8213600, aschenone@neurologia.unige.it

    Recruiting

  • A.O.U. Policlinico "G. Martino"

    Messina

    Massimo Russo, MD, massimo.russo@unime.it

    Not yet recruiting

  • San Gerardo Hospital

    Monza, Mb, 20900

    PAOLA ALBERTI, MD, PhD, paola.alberti@unimib.it

    GUIDO CAVALETTI, MD, guido.cavaletti@unimib.it

    Recruiting

  • Padova Hospital

    Padova

    BRIANI CHIARA, MD, + 39 049 8213600, chiara.briani@unipd.it

    Not yet recruiting

  • Azienda Ospedaliera Universitaria

    Verona

    Stefano Tamburin, MD, PhD, +39 3475235580, stefano.tamburin@univr.it

    Not yet recruiting

Other trials in Italy

France2 sites, 2 recruiting

  • Hôpital Percy

    Clamart

    Camille Tafani, MD, +33679848495, cdelescalopier@gmail.com

    Not yet recruiting

  • CHU Dupuytren

    Limoges

    Laurent Magy, MD, +335 55 05 65 68, laurent.magy@unilim.fr

    Not yet recruiting

Other trials in France

Greece2 sites, 2 recruiting

  • University of Larissa

    Larissa

    Efthmios Efthmios Dardiotis, MD, +302410685651, edar@med.uth.gr

    Not yet recruiting

  • "Saint Andrew's" State General Hospital

    Pátrai

    Andreas A Argyriou, MD, +30_2610_227908, andargyriou@yahoo.gr

    Recruiting

Other trials in Greece

Australia1 site, 1 recruiting

  • Brain and Mind Center

    Sydney

    Susanan B Park, PhD, +61293510701, susanna.park@sydney.edu.au

    Not yet recruiting

Other trials in Australia

Austria1 site, 1 recruiting

  • Dept. of Neurology, Medical University of Vienna

    Vienna

    Anna Grisold, MD, 004314040031450, anna.grisold@meduniwien.ac.at

    Not yet recruiting

Other trials in Austria

Bangladesh1 site, 1 recruiting

  • International Centre for Diarrhoeal Disease Research

    Dhaka

    Badrul Islam, +88 01711595367, bislamdmch@gmail.com

    Not yet recruiting

Other trials in Bangladesh

Brazil1 site, 1 recruiting

  • Clínica AMO

    Salvador

    André Muniz, MD, 557133116500, Muniz.a@uol.com.br

    Not yet recruiting

Other trials in Brazil

Canada1 site, 1 recruiting

  • The Ottawa Hospital

    Ottawa

    Kristopher Dennis, MD, 613) 737-7700 ext. 70212, krdennis@toh.ca

    Not yet recruiting

Other trials in Canada

Denmark1 site

  • Aarhus University Hospital

    Aarhus

    Withdrawn

Other trials in Denmark

Germany1 site, 1 recruiting

  • Center for Molecular Medicine

    Cologne

    Helmar Lehmann, MD, PhD, 0221-478-87091, helmar.lehmann@uk-koeln.de

    Not yet recruiting

Other trials in Germany

Kenya1 site, 1 recruiting

  • Medical Oncoloy Unit - University of Nairobi

    Nairobi

    Ezzi Mohamed, MD, +254721211807, mohammed.ezzi81@gmail.com

    Not yet recruiting

Other trials in Kenya

Portugal1 site, 1 recruiting

  • Centro Hospitalar Vila Nova de Gaia/Espinho

    Vila Nova de Gaia

    Anabela Amarelo, MD, +351917163485, anabelaamarelo@gmail.com

    Not yet recruiting

Other trials in Portugal

South Korea1 site, 1 recruiting

  • Dong-A University - Internal Medicine Dept.

    Busan

    Ji H Lee, MD, 82-51-240-5044, hidrleejh@dau.ac.kr

    Recruiting

Other trials in South Korea

Spain1 site, 1 recruiting

  • Hospital Universitari de Bellvitge-ICO L'Hospitalet

    Barcelona

    Jordi Bruna, MD, PhD, 0034932607711, jbruna@bellvitgehospital.cat

    Recruiting

Other trials in Spain

Switzerland1 site, 1 recruiting

  • University of Basel - Department of Sport, Exercise and Health

    Basel

    Fiona Streckmann, MD, +41 (0) 61 207 47 30, fiona.streckmann@unibas.ch

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study

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.

Read the detailed description

The study will be performed at all participating centers and will consist of the following assessments:

Core study (assessments at baseline and at the end of treatment)

  • Standard oncology assessment per local site
  • NCI-CTC (national cancer institute common toxicity criteria) v.5 sensory and motor
  • PRO-CTCAE (patient reported outcome-cancer common tocixity adverse event)
  • PI-NRS (pain intensity numeric rating scale)
  • NPS-CIN (Neuropathic Pain Scale for chemotherapy-induced neuropathy)
  • EORTC CIPN20© (The European Organisation of Research and Treatment of. Cancer Quality of Life Questionnaire-CIPN twenty-item scale)
  • FACT-GOG NTX v.4© (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity)
  • TNSn© (total neuropathy score, nurse version)
  • PGIC (patient global impression of change)
  • OXA-NQ (oxaliplatin neurotoxicity questionnaire)

Extended study (at all available sites - any combination of assessment methods is allowed, minimum at baseline and at the end of treatment)

  • EORTC CIPN15
  • CIPN-R-ODS (CIPN Rash overall disability scale)
  • TNSc© at the same time points as for questionnaire
  • OXA-NQ (also at mid-treatment)
  • nerve conduction study of the radial (motor and sensory), ulnar (motor and sensory), sural, dorsal sural and common peroneal nerves (*)
  • QST (*) [quantitative sensory testing]
  • Serum for biomarkers search (*)
  • DN4

Rationale: Within a multi-center international collaboration among experienced neurologists, oncologists, nurses and symptom scientists, the principal aim of this study is to evaluate responsiveness of a set of outcome measures for CIPN evaluation in order to define the gold standard for its assessment.

The assessment of CIPN will be performed at different levels of investigation. The Core study will allow the evaluation of subjects with common devices, so that an assessment can be performed at any medical site (expected time for questionnaires completion 15 minutes).

The Extended study will add any combination of the listed assessment methods/biological sample collection, in order to ascertain whether this approach can provide a more careful and clinically-relevant estimate of the peripheral nervous system damage. Comparison between healthcare evaluation and subjects' report of CIPN severity using established questionnaires will be performed in both Core and Extended studies.

Aims: The primary aim for this study is to test responsiveness of the different assessment methods used in the core study, in a multi-center, multi-regional International setting, comparing changes from baseline to end of treatment. Secondary aims are:

  • to evaluate responsiveness (changes from base line to end of treatment) also of the other outcome measures used in the Extended Study;
  • to evaluate mid-treatment data predictiveness of end of treatment neurological status for each outcome measure;
  • to evaluate recovery rate/modification of the neurological status for the follow up evaluations (3/6/12/24 months after treatment), stratifying data for different drugs.

Study Design: 1000 patients who are candidates for neurotoxic chemotherapy for any cancer with non-investigational drugs (including immune checkpoint inhibitors and "targeted" drugs) will be enrolled from participating centers. A trained investigator in each participating center will perform the selected healthcare-assessed scales and supervise the patient-completed measures as presented in Table 1. Subjects will be examined at least at baseline and end of treatment (Core Study) and at additional intermediate and follow-up timepoints (Extended study), according to their treatment plan.

Study Treatments: There are no study-specified treatments, as subjects will receive only their standard of care chemotherapy. The investigators will not influence decisions regarding treatment duration nor supply medication for this study. However, all treatment regimens will be registered.

Participating Centers minimum requirements: Participating Centers should:

  1. accept the study protocol and have their participation approved by a local Ethics Committee/Institutional Review Board
  2. have access through an internet connection to the secure server located at the main site
  3. guarantee the proper assessment of the selected patients at least at the Core study level
  4. have the potential to recruit at least 30 patients/year
  5. have the capacity to upload the data collected from each patient within 1 week
Being tested
outcome measures for CIPN testing
Keywords
clinimetrics, biomarker, PRO, outcome measures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • outcome measures for CIPN testingOther

    questionnaires administration, physician based scales for CIPN data collection

Study groups in NCT04633655
Study groupRoleWhat they receive
Patients who are receiving a neurotoxic chemotherapyList 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
Receives: Other: outcome measures for CIPN testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 5 YEARS

  2. 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)

    Measured: 5 YEARS

  3. 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).

    Measured: 5 YEARS

  4. 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)

    Measured: 5 YEARS

  5. 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)

    Measured: 5 YEARS

  6. 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)

    Measured: 5 YEARS

  7. 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)

    Measured: 5 YEARS

  8. 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)

    Measured: 5 YEARS

  9. 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)

    Measured: 5 YEARS

Secondary outcomes (6)

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

    difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN15 (changes of the global score of this questionnaire, 0-60)

    Measured: 7 YEARS

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

    difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSc© (changes of the global score of this physician base scale ranging 0-48)

    Measured: 7 YEARS

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

    difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in nerve conduction study of the radial (motor and sensory), ulnar (motor and sensory), sural, dorsal sural and common peroneal nerves. Amplitude (microV for sensory and mV for motor recordings) and velocity (m/sec) will be obtained. A decrease under the normative values at all time points respect to base line will be considered as sign of neuropathy.

    Measured: 7 YEARS

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

    difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in QST: scores in seconds for time to pain onset and pain intensity (0=no pain; 10=worst pain

    Measured: 7 YEARS

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

    difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in Serum for biomarkers search: NfL dosage (pg/mL)

    Measured: 7 YEARS

  6. Chemotherapy-induced peripheral neurotoxicity as assessed by change in DN4 scale

    difference between baseline and end of treatment of chemotherapy-induced peripheral neurotoxicity as assessed by change in DN4 (this is a scale ranging 0-10)

    Measured: 7 YEARS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start8 Jun 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633655
Sponsor's protocol ID
ICAVS
Acronym
ICAVS
Status last verified
Jul 2025
First submitted
9 Jun 2020
Last updated
25 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-induced Peripheral Neuropathy and Quality of Life, run by University of Milano Bicocca at 30 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Italy, France, Greece, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GUIDO CAVALETTI, MD (+ 39 02 6448 8039, guido.cavaletti@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade (time frame: 5 YEARS). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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