Assessment of chemotherapy-induced peripheral neuropathy across multiple centers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• "Saint Andrew's" State General Hospital
  Pátrai, Greece Recruiting
• San Gerardo Hospital
  Monza, Mb, Italy Recruiting
• Ospedale Policlinico San Martino
  Genova, Italy Recruiting
• Dong-A University - Internal Medicine Dept.
  Busan, South Korea Recruiting
• Hospital Universitari de Bellvitge-ICO L'Hospitalet
  Barcelona, Spain Recruiting
• Birmingham School of Nursing, University of Alabama
  Birmingham, Alabama, United States Not yet recruiting

Study contacts

• Principal investigator: Paola Alberti, Md — University of Milano Bicocca
• Study coordinator: Guido Cavaletti, Md
• Email: guido.cavaletti@unimib.it
• Phone: + 39 02 6448 8039

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling

  This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.

  Recruiting at 3 sites Azienda Sanitaria dell'Alto Adige · Bolzano, Bolzano and 3 other locations · NCT07780955

• SIR2501 plus Paclitaxel for solid tumors

  This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.

  Recruiting at 3 sites Phase 2 Sironax USA, Inc. · Hollywood, Florida and 4 other locations · NCT07765446

• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

  This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07673614

• Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy

  Researchers are testing a small, at-home device that you wear on the ear to see if it eases nerve pain from chemotherapy.

  Recruiting University of Miami · Coral Gables, Florida · NCT07596030

• Blood extracellular vesicles to detect chemotherapy-related nerve damage.

  We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07558447

• Virtual LASO-3 diet program to ease chemotherapy-related numbness and tingling

  This trial tests whether a virtual diet program that lowers added sugar and increases fiber and omega-3s can help cancer survivors who have numbness, tingling, or pain after neurotoxic chemotherapy.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07365007

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.