Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06627348

Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy

Led by University of Ulm · Updated on 2024-10-04

150

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

U

University of Ulm

Lead Sponsor

H

Hilotherm

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent for participation in this trial
  • Age 18 years or older
  • Female
  • Diagnosed with breast or genital cancer
  • Planned treatment with a Taxan-based chemotherapy regimen (Paclitaxel, Nab-Paclitaxel, Docetaxel) regardless of therapy line
  • No prior treatment with Taxan or Platin chemotherapy
  • Sufficient knowledge of German to complete patient history and questionnaires
Not Eligible

You will not qualify if you...

  • Existing peripheral polyneuropathy
  • Prior chemotherapy with taxan- and/or carboplatin-based regimens
  • Having diseases such as diabetes mellitus, neurological diseases affecting peripheral nerves (e.g., Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's disease), chronic pain syndrome, cryoglobulinemia, cold hemagglutination, cold hives/cold contact hives, Raynaud's disease, or significant peripheral artery disease
  • Lack of German language proficiency
  • Male gender

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Ulm

Ulm, Baden-Wurttemberg, Germany, 89075

Actively Recruiting

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Research Team

A

Angelina FINK, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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