Clinical trial NCT06627348: Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy
Official title: Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy - a Unicentric, Prospective-controlled, Randomized Clinical Trial for Comparison of Local Hilotherapy Vs. No Therapy to Prevent Peripheral Polyneuropathy During Taxan-based Chemotherapy Regimen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Equipment and Supplies
Keywords: Chemo-induced Peripheral Polyneuropathy
Taxan
Hilotherapy
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Hilotherm
First posted: 2024-10-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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, 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

Primary outcomes:
measure: incidence of peripheral polyneuropathy
timeFrame: Up to one year after the end of chemotherapy.
Secondary outcomes:
measure: Changes in the result of electrophysical examinations
timeFrame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
measure: Adverse effects of hilotherapy
timeFrame: Up to one year after the end of chemotherapy.
measure: Tolerance of chemotherapy
timeFrame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
measure: Patient reported Quality of Life
timeFrame: Up to one year after the end of chemotherapy.
measure: Residual Symptoms of Chemotherapy-induced polyneuropathy
timeFrame: Up to one year after the end of chemotherapy.
measure: Subjective extent of CIPN
timeFrame: Up to one year after the end of chemotherapy.
measure: Acceptance of hilotherapy
timeFrame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Hospital of Ulm
state: Baden-Württemberg
Study officials:
References: