Overview
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.
Description
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), a frequent and potentially dose-limiting toxicity caused by damage to peripheral nerves. Symptoms of CIPN may persist long after treatment completion and can significantly impair quality of life and daily functioning.
The application of cold to the hands and feet during chemotherapy administration may reduce the incidence and severity of CIPN by decreasing local blood flow and limiting exposure of peripheral nerves to chemotherapy agents. The aim of this study is to evaluate whether continuous-flow cryotherapy at 15°C during weekly paclitaxel administration can reduce the incidence and severity of CIPN in breast cancer patients.
Participants receiving continuous-flow 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 assessments of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and laboratory testing. In addition to routine blood tests, extra blood samples will be collected at two time points to assess biomarkers associated with nerve damage.
Eligibility
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
