Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy

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.

• Changes in the result of electrophysical examinations [Срок оценки: 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 [Срок оценки: Up to one year after the end of chemotherapy.]
• Tolerance of chemotherapy [Срок оценки: 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 [Срок оценки: Up to one year after the end of chemotherapy.]
• Residual Symptoms of Chemotherapy-induced polyneuropathy [Срок оценки: Up to one year after the end of chemotherapy.]
• Subjective extent of CIPN [Срок оценки: Up to one year after the end of chemotherapy.]
• Acceptance of hilotherapy [Срок оценки: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.]