Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients

Study Overview
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Brief Summary
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This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.

Detailed Description
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PRIMARY OBJECTIVE: I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. OUTLINE: Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.

Official Title
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Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Device: Medical Device Usage and Evaluation
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >= 18 years of age with a diagnosis of breast cancer Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks) Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Ability to complete questionnaires by themselves or with assistance Ability to give signed informed consent Exclusion Criteria: History of prior sensory/motor peripheral neuropathy from any cause History of prior Raynaud's phenomenon History of cryoglobulinemia Active peripheral vascular disease Cold intolerance Prior exposure to neurotoxic chemotherapy in the last 10 years Hand-foot syndrome Tumor metastasis in bone, soft tissue, or skin of the hands or feet Absence of one or more fingers or toes Prior exposure to taxane chemotherapy

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (Elasto Gel Therapy Mittens and Foot Wraps)<br>Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. | Device: Medical Device Usage and Evaluation<br>* Wear Elasto Gel Therapy Mittens and Foot Wraps<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral neuropathy (PN) | The overall estimate of PN in the group will be estimated with a simple percentage, and 95% confidence intervals will be calculated for that estimate. In additional other measures of symptoms or other parameters will be summarized in the group. Categorical parameters will be estimated using percentages, and continuous measures will be summarized using means, or medians. The decision about which measure to use for the continuous measures will depend on the distribution of the data of interest. | Up to 3 months post chemotherapy |