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Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy

Sponsor: Azienda Sanitaria dell'Alto Adige • ClinicalTrials.gov ID: NCT07780955

Registry updated: 2026-08-24

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Description

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.

Interventions

Cryotherapy (Device)
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.

Eligibility criteria

Inclusion Criteria: * Paclitaxel weekly (80 mg/m2) at least 12 cycles (in adjuvant, neo-adjuvant setting or metastatic setting following the present schemes: TH (Paclitaxel, Trastuzumab), AC-TH (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab), AC-THP (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab), AC-T (Doxorubicin, Cyclophosphamide, Paclitaxel) * Eastern Cooperative Oncology Group Performance Status (ECOG) \< 2 * Female sex * Age: 18-90 years * written informed consent Exclusion Criteria: * pre-existing motor/sensitive peripheral neuropathy * diabetes * Endocrinopathies * presence of brain, bone, soft tissue, or skin of hands or feet metastases * Raynaud's syndrome * Peripheral arterial disease * hand and foot syndrome * any other reason that may hamper the data collection as assessed by the examiner

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy CIPN CIPN in Adjuvant Breast Cancer Patients Chemotherapy Induced Peripheral Neuropathy Chemotherapy Induced Peripheral Neuropathy (CIPN)

Locations

Ospedale di Bolzano — Bolzano, Bolzano, Italy
Ospedale di Bressanone — Brixen, Bolzano, Italy
Ospedale di Brunico — Bruneck, Bolzano, Italy
Ospedale di Merano — Merano, Bolzano, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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