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The Mamma HiToP Study
Sponsor: Vienna Hospital Association
Summary
The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia. The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. The study is multicenter, randomized, double-blind, and placebo-controlled. Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.
Official title: High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2023-11-03
Completion Date
2024-12-31
Last Updated
2024-04-26
Healthy Volunteers
No
Interventions
HiToP 191 PNP
High tone therapy
Placebo device
Placebo therapy
Locations (1)
Clinics Donaustadt, Ottakring, Hietzing
Vienna, Austria