Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy (HiPPo)

University of Ulm

Status

Enrolling

Conditions

Equipment and Supplies

Treatments

Device: Hilotherm ChemoCare

Study type

Interventional

Funder types

Other

Identifiers

NCT06627348

HIPPO

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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, 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

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 (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