An observational study in Chemotherapy-induced Peripheral Neuropathy and Quality of Life, sponsored by University of Milano Bicocca. Recruiting at 30 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by University of Milano Bicocca · Observational
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.
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)
Extended study (at all available sites - any combination of assessment methods is allowed, minimum at baseline and at the end of treatment)
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:
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:
University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients candidated to neurotoxic chemotherapy
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
Subjects presenting with any of the following will not be included in the study:
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
questionnaires administration, physician based scales for CIPN data collection
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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 5 YEARS
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)
Time frame: 7 YEARS
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)
Time frame: 7 YEARS
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.
Time frame: 7 YEARS
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
Time frame: 7 YEARS
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)
Time frame: 7 YEARS
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)
Time frame: 7 YEARS
Plan to share: No
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University of Milano Bicocca