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| Name | Class |
|---|---|
| Inova Health Care Services | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Experimental | Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gelâ„¢ 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Other |
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| |
| Paclitaxel |
| 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. |
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mary J Wilkinson, MD | Medical Oncology & Hematology Associates of Northern Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology & Hematology Associates of Northern Virginia | Fairfax | Virginia | 22031 | United States | ||
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
|
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| Medical Oncology & Hematology Associates of Northern Virginia |
| Reston |
| Virginia |
| 20190 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |