An interventional study of hilotherapy and frozen gloves in Breast Cancer, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 62 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Device: hilotherapy
Device: frozen gloves
continuous cooling of hands and feet at a constant temperature
cooling of hands and feet using frozen gloves
any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)
Time frame: 24 weeks
grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)
Time frame: 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven