Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hilotherm ChemoCare.
- Who it may be relevant to
- Registry conditions: Equipment and Supplies. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Hilotherm ChemoCare
Hilotherapy
Primary outcome measures
- incidence of peripheral polyneuropathy [Time frame: Up to one year after the end of chemotherapy.]
Secondary outcome measures (7)
- Changes in the result of electrophysical examinations [Time frame: 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 [Time frame: Up to one year after the end of chemotherapy.]
- Tolerance 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.]
- Patient reported Quality of Life [Time frame: Up to one year after the end of chemotherapy.]
- Residual Symptoms of Chemotherapy-induced polyneuropathy [Time frame: Up to one year after the end of chemotherapy.]
- Subjective extent of CIPN [Time frame: Up to one year after the end of chemotherapy.]
- Acceptance of hilotherapy [Time frame: From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- University Hospital of Ulm — Ulm
Identifiers
NCT: NCT06627348 · HIPPO