Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity: A Prospective Self-controlled Trial Comparing Hilotherapy With Frozen Gloves in Early Breast Cancer
NCT ID: NCT04659980
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2019-06-20
2020-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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hilotherapy
hilotherapy
continuous cooling of hands and feet at a constant temperature
frozen gloves
frozen gloves
cooling of hands and feet using frozen gloves
Interventions
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hilotherapy
continuous cooling of hands and feet at a constant temperature
frozen gloves
cooling of hands and feet using frozen gloves
Eligibility Criteria
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Inclusion Criteria
* treated with weekly paclitaxel 80 mg/m² (12 cycles) or three-weekly docetaxel 75 mg/m² (4 or 6 cycles) in an adjuvant or neo-adjuvant setting.
Exclusion Criteria
* Raynaud's phenomenon, cold intolerance or any condition to the nails or peripheral blood vessels that could pose a risk to the compliance with the study interventions
* insufficient understanding of the Dutch language for self-reporting the side-effects under investigation
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.
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S62794
Identifier Type: -
Identifier Source: org_study_id
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