Cooling treatment to prevent nerve damage from chemotherapy
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
Run by University of Ulm · NCT06627348 · Data updated 2026-11-12
This study is testing if a cooling treatment for the hands and feet can help women undergoing chemotherapy for breast and gynecological cancers avoid nerve damage.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | University of Ulm Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | April 17, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 4, 2024 |
| Trial ID | NCT06627348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with breast or genital cancers who are about to start Taxan-based chemotherapy.
✕Probably not a fit
Patients with pre-existing peripheral neuropathy or those who have previously received Taxan- or carboplatin-based chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the use of hilotherapy, a cooling treatment for the hands and feet, to prevent chemotherapy-induced peripheral polyneuropathy in women undergoing Taxan-based chemotherapy for breast and gynecological cancers. Participants will be randomly assigned to receive either the cooling treatment or standard care without cooling during their chemotherapy sessions. The study will assess the occurrence and severity of peripheral neuropathy through neurological examinations and quality of life questionnaires at various points during and after treatment.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence and severity of nerve damage caused by chemotherapy, improving patients' quality of life.
How similar studies have gone: While the use of cooling therapies in chemotherapy is explored, this specific approach with hilotherapy is relatively novel and has not been extensively tested in this context.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Hospital of Ulm
Ulm, Baden-Wurttemberg, Germany Recruiting
Study contacts
- Study coordinator: Angelina FINK, Dr. med.
- Email: angelina.fink@uniklinik-ulm.de
- Phone: +4973150058688
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.