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Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy
Sponsor: Azienda Sanitaria dell'Alto Adige
Summary
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), which may negatively affect quality of life and lead to treatment modifications or discontinuation. The aim of this clinical trial is to evaluate whether acral cryotherapy during chemotherapy administration can reduce the incidence and severity of CIPN. Participants receiving cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial evaluations of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and blood tests. In addition to routine laboratory testing, extra blood samples will be collected at two time points to assess biomarkers of nerve damage.
Official title: Multimodal Evaluation of Cryotherapy to Reduce Incidence of Chemotherapy-induced Peripheral Neurotoxicity in Breast Cancer Patients Treated With Paclitaxel Weekly
Key Details
Gender
FEMALE
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-10-11
Completion Date
2028-10
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
Cryotherapy
Hilotherm Chemocare™ is a dedicated cryotherapy device designed for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. The system consists of a closed-loop circulation unit through which a temperature-controlled cooling medium is delivered to specially designed cuffs applied to the hands and feet. A processor-controlled system maintains a stable and continuous temperature throughout the treatment session. For CIPN prevention, the manufacturer-recommended target temperature is set at 15°C. Cryotherapy will be administered starting 15 minutes before the initiation of chemotherapy infusion, continued throughout the entire duration of chemotherapy administration, and maintained for 15 minutes after completion of the infusion.
Locations (4)
Ospedale di Bolzano
Bolzano, Bolzano, Italy
Ospedale di Bressanone
Brixen, Bolzano, Italy
Ospedale di Brunico
Bruneck, Bolzano, Italy
Ospedale di Merano
Merano, Bolzano, Italy