RecruitingNot ApplicableNCT06132776

The Mamma HiToP Study

High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients


Sponsor

Vienna Hospital Association

Enrollment

160 participants

Start Date

Nov 3, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (Mamma HiToP) tests whether high-tone external muscle stimulation therapy can help relieve the tingling, numbness, and nerve pain (called chemotherapy-induced peripheral neuropathy) in breast cancer patients who have received taxane-based chemotherapy (such as paclitaxel or docetaxel). **You may be eligible if...** - You have been diagnosed with breast cancer and received at least 3 cycles of a taxane-based chemotherapy - It has been at least 2 weeks since your last chemotherapy cycle - You have mild-to-moderate nerve symptoms (tingling, numbness) in your hands or feet - You are able to walk (with or without aids) and have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have nerve damage from another cause (such as diabetes) - You have a pacemaker or implanted defibrillator - You have severe psychiatric or neurological conditions - You are pregnant - You have epilepsy - You have poor circulation in your legs (peripheral arterial disease grade >2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHiToP 191 PNP

High tone therapy

DEVICEPlacebo device

Placebo therapy


Locations(1)

Clinics Donaustadt, Ottakring, Hietzing

Vienna, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06132776