International CIPN Assessment and Validation Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Consecutive patients candidated to neurotoxic chemotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
outcome measures for CIPN testing
Other interventionquestionnaires administration, physician based scales for CIPN data collection
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Patients who are receiving a neurotoxic chemotherapy1 intervention
Trial outcomes
Primary outcomes
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)
Time frame
5 YEARS2
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 YEARS3
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 YEARS4
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 YEARSSecondary outcomes
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)
Time frame
7 YEARS2
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 YEARS3
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 YEARS4
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 YEARSSponsors and contacts
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Source ClinicalTrials.gov