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RECRUITING
NCT06132776
NA

The Mamma HiToP Study

Sponsor: Vienna Hospital Association

View on ClinicalTrials.gov

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

DEVICE

HiToP 191 PNP

High tone therapy

DEVICE

Placebo device

Placebo therapy

Locations (1)

Clinics Donaustadt, Ottakring, Hietzing

Vienna, Austria