Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy
NCT ID: NCT06627348
Last Updated: 2024-10-04
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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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-04-17
2027-03-31
Brief Summary
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Detailed Description
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if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy.
To assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen.
Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Hilotherapy
Cooling of hands and feet during Taxan-based chemotherapy
Hilotherm ChemoCare
Hilotherapy
No Cooling
No cooling of hands and feet during Taxan-based chemotherapy
No interventions assigned to this group
Interventions
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Hilotherm ChemoCare
Hilotherapy
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Female
* Breast or genital cancer of the woman
* Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nab-Paclitaxel, Docetaxel) independent of the therapy line
* Taxan- and Platin-naivity
* Sufficient knowledge of the German language to assure an adequat survey of patient's history
Exclusion Criteria
* chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy
* Existence of one of the following diseases: Diabetes mellitus (of any type), neurological diseases that are involving peripheral nerve damage (e.g. Multiple Sclerosis, Amytrophic lateral sclerosis, Parkinson's disease), chronic pain syndrome, Cryoglobulinemia, cold hemagglutination, cold hives / cold contact hives, Raynaud's disease, significant peripheral artery disease,
* Lack of knowledge of German
* Males
18 Years
FEMALE
No
Sponsors
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Hilotherm
UNKNOWN
University of Ulm
OTHER
Responsible Party
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Prof. Wolfgang Janni
Director of the Department of Gynecology and Obstetrics
Locations
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University Hospital of Ulm
Ulm, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HIPPO
Identifier Type: -
Identifier Source: org_study_id
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