G62.0 C50.9 C54 C56 C53
Conditions
Interventions
Group 1: no hilotherapy of hands and feet
Group 2: hilotherapy of hands and feet
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: * Written consent for participation in this trail * Age =18 years * Female * Breast or genital cancer of the woman * Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nac-Paclitaxel) 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
Exclusion criteria: * pre-existing peripheral polyneuropathy • 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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS = 11) in patients with gynecologic malignoma that are undergoing Taxan-based chemotherapy regimen with or without a preventive hilotherapy of hands and feet. Study visits will take place at the beginning, in the middle and at the end of the planned chemotherapy regimen. Additionally, two follow-up visits will take place six months and twelve months after the end of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Subjective extent of CIPN as measured with the EORTC QLQ-CIPN20 questionnaire. * Changes in the result of electrophysical examinations before and after chemotherapy. * Acceptance of hilotherapy measured as the amount of patients that have to stop local cold application during a session (> 5 miutes) or terminate earlier or stop the treament completely for the rest of chemotherapy. * Adverse effects of hilotherapy documented as any adverse event. * Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy. * Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire * Comparison of the time of regression, cTNS score of persisting symptoms and amount of patients without residues after end of chemotherapy and follow-up between patients with and without preventive hilotherapy. | — |
Countries
Germany
Outcome results
None listed