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Assessment of chemotherapy-induced peripheral neuropathy across multiple centers

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

University of Milano Bicocca · NCT04633655

This study is trying to understand how chemotherapy affects nerve function and quality of life in patients with chemotherapy-induced peripheral neuropathy by using different tests and measures.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Milano Bicocca (other)
Drugs / interventionschemotherapy
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT04633655 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the responsiveness of various outcome measures in patients experiencing chemotherapy-induced peripheral neuropathy (CIPN). Conducted internationally, it will involve assessments at baseline and the end of treatment, utilizing a range of standardized tools to measure sensory and motor function, pain intensity, and quality of life. The study will also explore biomarkers and nerve conduction studies to enhance understanding of CIPN. By collaborating with experienced neurologists and oncologists, the study seeks to provide comprehensive insights into the impact of neurotoxic chemotherapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are set to receive neurotoxic chemotherapy and have a Karnofsky performance score of 70 or higher.

Not a fit: Patients with poor prognosis or pre-existing neurologic conditions that could complicate assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved assessment and management strategies for patients suffering from CIPN, enhancing their quality of life.

How similar studies have performed: Other studies have shown promise in assessing CIPN using similar outcome measures, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chemotherapy-induced Peripheral Neuropathy, Quality of Life, clinimetrics, biomarker, PRO, outcome measures

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.