Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy
ConditionEquipment and Supplies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Ulm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written consent for participation in this trail
Age ≥18 years
Female
Breast or genital cancer of the woman
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hilotherm ChemoCare
DeviceHilotherapy
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: HilotherapyActive comparator 1 intervention
Group B: No CoolingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to one year after the end of chemotherapy.Secondary outcomes
1
Changes in the result of electrophysical examinations
Changes in the result of electrophysical examinations before and after chemotherapy.
Time frame
From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.2
Adverse effects of hilotherapy
Adverse effects of hilotherapy documented as any adverse event.
Time frame
Up to one year after the end of chemotherapy.3
Tolerance of chemotherapy
Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy.
Time frame
From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.4
Patient reported Quality of Life
Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire
Time frame
Up to one year after the end of chemotherapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Ulm
Lead sponsor
Hilotherm
Collaborator
Source ClinicalTrials.gov