Prevention of Paclitaxel Neuropathy With Cryotherapy

Study Overview
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Brief Summary
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The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.

Official Title
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Prevention of Paclitaxel Neuropathy With Cryotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Cryotherapy
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Women 18 years of age or older Histologically or cytological proven diagnosis of breast cancer Stage I- III. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting. May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Patient signed informed consent. Patient willing and able to comply with scheduled visits and treatment plan. Exclusion Criteria Patient presents with Grade 2 or greater peripheral neuropathy. History of Raynaud's Disease. Patient presents open or poorly-healing wounds on the hands or feet. Patients with cold intolerance. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Cryotherapy<br>Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes. | Other: Cryotherapy<br> <br> * Other names: Elasto gel™;Drug: Paclitaxel<br> <br> * Other names: Taxanes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel. |  | From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy. |  | From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryotherapy, Cold therapy, Peripheral Neuropathy, Paclitaxel, Breast Cancer, Symptom management, Prevention