RecruitingNot ApplicableNCT06627348

Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy

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


Sponsor

University of Ulm

Enrollment

150 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

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Interventions

DEVICEHilotherm ChemoCare

Hilotherapy


Locations(1)

University Hospital of Ulm

Ulm, Baden-Wurttemberg, Germany

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NCT06627348


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