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NCT07780955 · ClinicalTrials.gov record · last posted 2026-08-24

Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy

StatusRecruiting
PhaseNot applicable
Started2025-10-11
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07780955
Lead Sponsor Azienda Sanitaria dell'Alto Adige
Collaborators: University of Milano Bicocca, Paracelsus Medical University
Conditions CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN, CIPN in Adjuvant Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy (CIPN)
Enrollment 144 participants
Start Date 2025-10-11
Primary Completion 2028-07 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-24