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NCT06132776

The Mamma HiToP Study

High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
Vienna Hospital Association·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chemotherapy-induced Peripheral Neuropathy
Drug/Device/Intervention
HiToP 191 PNP
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Vienna Hospital Association
Location
Vienna, Austria
Timeline & enrollment
Phase
N/A
Start date
Nov 03, 2023
End date
Dec 31, 2024
Enrollment
160 participants
Primary outcome

Alleviation of paresthesias (VAS)

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.

ICD-10 classifications
Drug-induced polyneuropathyParaneoplastic neuromyopathy and neuropathyPolyneuropathy due to other toxic agentsIdiopathic peripheral autonomic neuropathyIdiopathic progressive neuropathy
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06132776
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06132776 through Pure Global AI's free database. This phase not specified trial is sponsored by Vienna Hospital Association and is currently Recruiting. The study focuses on Chemotherapy-induced Peripheral Neuropathy. Target enrollment is 160 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.