Understanding the socio-economic impact of chemotherapy-induced peripheral neurotoxicity

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 pilot study focuses on the socio-economic burden associated with chemotherapy-induced peripheral neurotoxicity (CIPN) in cancer patients. It will collect detailed healthcare-related costs and patient assessments, including neurological evaluations and patient-reported outcomes. Additionally, the study aims to compare collected data with larger administrative datasets to identify potential proxy variables for CIPN. This approach seeks to enhance understanding of CIPN's impact on patients and inform policy decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cancer patients with this characteristics:

   1. at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);
   2. at least 75 consecutive subjects sent for a neurological evaluation due to stable CIPN condition (CIPN defined as TNSc \> or = 1) after chemotherapy completion (at least 2 months off treatment).
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:

1. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
2. Severe depression that in the opinion of the Investigator would complicate the assessments.
3. 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).
4. Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes)
5. 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.

Where it's running

• ASST Monza
  Monza, Italy Recruiting

Study contacts

• Study coordinator: Paola Alberti, MD
• Email: paola.alberti@unimib.it
• Phone: +39 02 6448 8154

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

• Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy

  This study tests whether adding a structured exercise program to electroacupuncture helps cancer survivors with CIPN more than electroacupuncture alone.

  Recruiting at 2 sites Show Chwan Memorial Hospital · Changhua, Changhua and 1 other locations · NCT07700901

• Virtual exercise program to help with chemotherapy-induced nerve symptoms

  This trial tests whether a remote, personalized exercise program (EX-CIPN) can reduce CIPN symptoms and related disability in cancer survivors who have persistent neuropathy after chemotherapy, compared with usual care.

  Recruiting Phase 3 University Health Network, Toronto · Toronto, Ontario · NCT07481149

• Acupuncture and compression to prevent chemotherapy-induced nerve damage in breast cancer

  This trial will test whether wearing compression garments and/or receiving acupuncture during taxane chemotherapy can prevent chemotherapy-induced peripheral neuropathy in adults with early-stage breast cancer.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07377279

• PEA and Scutellaria combined with exercise for chemotherapy-related nerve pain

  This trial will see if taking PEA and Scutellaria together with therapeutic exercise helps adults who have nerve pain after chemotherapy.

  Recruiting University of Palermo · Palermo, Italia · NCT07352514

• Assessing Functional Impairments in CIPN Patients

  This study tests how CIPN affects daily function by using functional tests alongside patient self-reports to see how well the tests reflect everyday difficulties.

  Recruiting Paracelsus Medical University · Salzburg · NCT07315334

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.