The Mamma HiToP Study

Study Overview
=================
Brief 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

Conditions
-----------------
Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
-----------------
* Device: HiToP 191 PNP
* Device: Placebo device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with histologically verified breast cancer and neoadjuvant or adjuvant treatment with a taxane derivate (e.g., Paclitaxel, Docetaxel): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9. Cumulative dose of at least 3 cycles Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects Life expectancy of at least 3 months Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying) Ability to walk (with or without aids) European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2 Intensity of paresthesias of > 3/10 on the Visual Analog Scale (VAS) Exclusion Criteria: - Prevalent neuropathy of different etiology Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators Epilepsy Minors or persons unable to give informed consent Current neurotoxic medication Implanted pacemakers or defibrillators Pregnancy Wounds in the area to be treated, acute local or systemic infection Peripheral arterial occlusive disease > grade 2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, double-blind, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum group<br> | Device: HiToP 191 PNP<br>* High tone therapy<br>|
| Placebo Comparator: Placebo group<br> | Device: Placebo device<br>* Placebo therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alleviation of paresthesias (VAS) |  | baseline vs. one day after the last treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further neuropathic symptoms (via VAS questionnaire) | e.g., intensity of tightness, cramps | baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session | 
| Further neuropathic symptoms (via EORCT CIPN20 questionnaire) | sensory, motor and autonomic scale | baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session | 
| Quality of life (via EORCT C30 questionnaire) | global health status, physical function, symptom scales | baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session |