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The prevention of taxane-related toxicities at the extremities is highly important for patients' treatment and quality-of-life. Unlike standard cryotherapy with frozen gloves, hilotherapy produces cooling at a constant temperature. Comparative data with frozen gloves are unavailable. This prospective self-controlled study explores the efficacy of hilotherapy at the right hand and foot compared to frozen gloves at the left in patients with early breast cancer treated with weekly paclitaxel 80 mg/m² or three-weekly docetaxel 75 mg/m².
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hilotherapy | Active Comparator |
| |
| frozen gloves | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hilotherapy | Device | continuous cooling of hands and feet at a constant temperature |
| |
| Measure | Description | Time Frame |
|---|---|---|
| any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities) | 24 weeks |
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Inclusion criteria:
Exclusion criteria:
Patients were excluded from the analysis if they received less than two thirds of planned treatment cycles, for other reasons than the side-effects investigated in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Belgium |
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| frozen gloves |
| Device |
cooling of hands and feet using frozen gloves |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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