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International Study of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

This is an observational study looking at chemotherapy-induced peripheral neuropathy (CIPN), a type of nerve damage that can be caused by certain cancer treatments. The study aims to understand how different ways of measuring CIPN, like questionnaires and doctor-based scales, work in people receiving chemotherapy. You could be eligible if you are 18 years or older and are about to start chemotherapy that is known to potentially cause nerve damage. The study will follow participants for up to 5 years to see how CIPN changes over time, using tools like the NCI-CTC v.5 (a scale for side effects), PRO-CTCAE (patient-reported side effects), and a pain intensity scale. The current recruitment status is unclear, and the study plans to enroll 1000 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatment. It plans to enroll 1000 participants.
What's involved
You would complete various questionnaires and have doctor-based assessments at the start of your chemotherapy and at the end of treatment. Some sites may also include additional tests like nerve conduction studies or blood tests.
Compensation
Not stated in the trial record.
Follow-up
Your chemotherapy-induced peripheral neuropathy will be assessed for up to 5 years after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04633655

International CIPN Assessment and Validation Study

Recruiting
Not specifiedAges 18+Observational
University of Milano Bicocca
~1,000 participants
Updated 2025-07-25 on ClinicalTrials.gov
What's tested:outcome measures for CIPN testing

At a glance

Recruiting sites
5 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade
Measured over 5 YEARS
+8 more outcomes measured

Conditions

Chemotherapy-induced Peripheral Neuropathy
Quality of Life

Explore related trials

Chemotherapy-Induced Peripheral Neuropathy

Where it's being run

30 sites across 24 states
Italy5
France2
Greece2
Alabama1
Georgia1
Maryland1
Michigan1
New York1

Study leadership

  • GUIDO CAVALETTI, MD · STUDY_CHAIR · University of Milano Bicocca
  • PAOLA ALBERTI, MD · PRINCIPAL_INVESTIGATOR · University of Milano Bicocca

Who to contact

GUIDO CAVALETTI, MD
[email protected]
+ 39 02 6448 8039
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade5 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-CTCAE5 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 scale5 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© scale5 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© scale5 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© scale5 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 scale5 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 scale5 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)