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

Not Applicable

Completed

Brief Summary: To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Detailed Description: 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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.

Primary Outcome Measures

Name	Time	Method
Prevention of Peripheral Neuropathy During Taxane Chemotherapy	Change from baseline to 6 months post chemo (up to 14 months)	A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.
Evaluate Safety of Cryotherapy Use	Baseline to 6 months post Cryotherapy (up to 14 months)	Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes

Secondary Outcome Measures