Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

This is a therapeutic study investigating the use of cryotherapy in the prevention of
chemotherapy-induced peripheral neuropathy (CIPN) and associated nail toxicities. The
therapeutic intervention will involve patients wearing an Elasto-Gel cold glove and sock on
one hand and one foot (both on the right side or both on the left side). The patients will
wear the glove and sock during each infusion of taxane chemotherapy.

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.

- Age > 18 years. There is no upper age limit for participation in this study.

- 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 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: 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 participant in the clinical trial

- Must not be pregnant or breast feeding