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| Name | Class |
|---|---|
| Hilotherm | UNKNOWN |
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Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.
In this trial, patients receiving Taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17°C. Randomization will be 50:50.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hilotherapy | Active Comparator | Cooling of hands and feet during Taxan-based chemotherapy |
|
| No Cooling | No Intervention | No cooling of hands and feet during Taxan-based chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hilotherm ChemoCare | Device | Hilotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of peripheral polyneuropathy | 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. | Up to one year after the end of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the result of electrophysical examinations | Changes in the result of electrophysical examinations before and after chemotherapy. | From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks. |
| Adverse effects of hilotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelina FINK, Dr. med. | Contact | +4973150058688 | angelina.fink@uniklinik-ulm.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Ulm | Recruiting | Ulm | Baden-Wurttemberg | 89075 | Germany |
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Adverse effects of hilotherapy documented as any adverse event. |
| Up to one year after the end of chemotherapy. |
| Tolerance of chemotherapy | Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy. | From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks. |
| Patient reported Quality of Life | Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire | Up to one year after the end of chemotherapy. |
| Residual Symptoms of Chemotherapy-induced polyneuropathy | 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. | Up to one year after the end of chemotherapy. |
| Subjective extent of CIPN | Subjective extent of CIPN as measured with the EORTC QLQ-CIPN20 (quality of life questionnaire regarding chemotherapy-induced peripheral neuropathy with 20 questins) questionnaire. The qustionnaire consits of 20 items on 3 scales. The minimum is 0, the maximum is 100 points. The higher the score, the worse the CIPN. | Up to one year after the end of chemotherapy. |
| Acceptance of hilotherapy | Acceptance of hilotherapy measured as the amount of patients that have to stop local cold application during a session (up to 5 minutes) or terminate earlier or stop the treament completely for the rest of chemotherapy. | From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks. |