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International CIPN Assessment and Validation Study (ICAVS)

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ClinicalTrials.gov Identifier: NCT04633655
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Chemotherapy-induced Peripheral Neuropathy Quality of Life Other: outcome measures for CIPN testing

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Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : October 1, 2025

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients who are receiving a neurotoxic chemotherapy

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


Outcome Measures
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Primary Outcome Measures :
  1. Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade [ Time Frame: 5 YEARS ]
    NCI-CTC v.5 sensory and motor (changes from base line to end treatment of a 0-5 score)

  2. Chemotherapy-induced peripheral neurotoxicity as assessed by change in PRO-CTCAE [ Time Frame: 5 YEARS ]
    PRO-CTCAE (changes from base line to end treatment of a 0-5 score for each item)

  3. Chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 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).

  4. Chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN scale [ Time Frame: 5 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)

  5. Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© scale [ Time Frame: 5 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)

  6. Chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© scale [ Time Frame: 5 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)

  7. Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© scale [ Time Frame: 5 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)

  8. Chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC scale [ Time Frame: 5 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)

  9. Chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ scale [ Time Frame: 5 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)


Secondary Outcome Measures :
  1. Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN15 scale [ Time Frame: 7 YEARS ]
    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)

  2. Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSc© scale [ Time Frame: 7 YEARS ]
    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)

  3. Chemotherapy-induced peripheral neurotoxicity as assessed by change in nerve conduction studies [ Time Frame: 7 YEARS ]
    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.

  4. Chemotherapy-induced peripheral neurotoxicity as assessed by change in Quantitative sensory testing (QST) [ Time Frame: 7 YEARS ]
    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

  5. Chemotherapy-induced peripheral neurotoxicity as assessed by change in neurofilament light chain (NfL) levels [ Time Frame: 7 YEARS ]
    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)

  6. Chemotherapy-induced peripheral neurotoxicity as assessed by change in DN4 scale [ Time Frame: 7 YEARS ]
    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)


Biospecimen Retention:   Samples Without DNA
Serum samples for neurofilament light chain detection

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients candidated to neurotoxic chemotherapy
Criteria

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:

  1. Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).
  2. Male and female subjects who are 18 years of age or older.
  3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
  4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
  5. Subjects must have a Karnofsky performance score greater than or equal to 70. Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

  1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
  2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
  3. Severe depression that in the opinion of the Investigator would complicate the assessments.
  4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
  5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
  6. 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).
  7. 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.
  8. Previous neurotoxic chemotherapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633655


Contacts
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Contact: GUIDO CAVALETTI, MD + 39 02 6448 8039 guido.cavaletti@unimib.it
Contact: PAOLA ALBERTI, MD, PhD +39 02 6448 8154 paola.alberti@unimib.it

Locations
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Sponsors and Collaborators
University of Milano Bicocca
Investigators
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Study Chair: GUIDO CAVALETTI, MD University of Milano Bicocca
Principal Investigator: PAOLA ALBERTI, MD University of Milano Bicocca
More Information
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04633655    
Other Study ID Numbers: ICAVS
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
clinimetrics
biomarker
PRO
outcome measures
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases