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

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

Detailed Description
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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.

Official Title
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Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

Conditions
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Peripheral Neuropathies

Intervention / Treatment
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* Device: Cryotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryotherapy<br>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. | Device: Cryotherapy<br>* An Elasto gel™ frozen (4°C) glove and sock<br>* Other names: Elasto gel™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of peripheral neuropathy during taxane chemotherapy | Subjects will be asked to complete sensory questionnaires | Change from baseline to 6 months post chemo |