Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy

Inclusion Criteria

• •Women \> 18 years of age
• •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• •Radically operated infiltrating breast cancer, pT1-T3, pN0-2, M0
• •Candidate to adjuvant chemotherapy that includes weekly paclitaxel 80 mg/m2 intravenous for 12 weeks \[either following anthracyclines and/or in association with trastuzumab\]
• •Negative pregnancy test at baseline (in fertile women)
• •Willing and able to sign informed consent for protocol treatment
• •Any serious concurrent infection or any clinically significant medical illness (in particular clinically significant liver disease, clinically significant renal dysfunction, clinically significant cardiovascular disease, uncontrolled infections) which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• •Pre-existing motor or sensory neuropathy of any grade, for any reason
• •Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause PN
• •History of Raynaud phenomenon, either primary or secondary to autoimmune or connective tissue diseases such as systemic lupus erythematous, scleroderma, Buerger disease, Sjögren syndrome, rheumatoid arthritis, occlusive vascular disease, such as atherosclerosis, polymyositis, cold agglutinin disease or cryoglobulinemia, thyroid disorders, pulmonary hypertension
• •Cold urticaria / cold contact urticaria
• •Severe arterial disease
• •Trophic tissue lesions
• •Diabetes mellitus
• •Alcohol abuse
• •History of severe allergic, anaphylactic, or other hypersensitivity reactions to the components of Hilotherm Chemo care device
• •Simultaneous use of Dignicap system to prevent hair loss from chemotherapy