Cryotherapy in Preventing Chemotherapy-Related Peripheral Neuropathy and Nail Toxicity in Patients with Stage I-III Breast Cancer

Inclusion Criteria

• Histologically confirmed diagnosis of early stage breast cancer (stage I-III)
• Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy
• Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation
• Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs
• All patients will have given signed, informed consent prior to registration
• Patients must have a performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria

• Patients must not have received any prior taxane or platinum based chemotherapy
• Patients must not have a history of peripheral neuropathy (regardless of cause)
• Patient must not have a history of Raynaud’s disease
• Patients with partial or complete limb amputations
• Known hypersensitivity to cold
• Patient cannot be on the following medications: gamma-aminobutyric acid (GABA) analogues (such as Neurontin, Lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline)
• As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements
• Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
• Must not be pregnant or breast feeding