The Mamma HiToP Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: HiToP 191 PNP; Device: Placebo device

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Wakolbinger-Habel, MD, PhD; Phone Number: +43 1 28802 4604; Email: robert.wakolbinger-habel@gesundheitsverbund.at
• Study Contact Backup: Name: Brigitte E Scheffold, MD, MSc, MSc; Phone Number: +43 1 28802 4604; Email: brigitteelisabeth.scheffold@gesundheitsverbund.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Clinics Donaustadt, Ottakring, Hietzing
    • Contact: Robert Wakolbinger-Habel, MD, PhD; Phone Number: 4604 +43 1 28802; Email: robert.wakolbinger-habel@gesundheitsverbund.at
    • Contact: Brigitte E Scheffold, MD, MSc, MSc; Phone Number: 4604 +43 1 28802; Email: brigitteelisabeth.scheffold@gesundheitsverbund.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Device: Placebo device; Placebo therapy
Experimental: Verum group	Device: HiToP 191 PNP; High tone therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vienna Hospital Association
• Investigators: Study Director: Tatjana Paternostro-Sluga, MD, Vienna Healthcare Group

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): November 2, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CIP_Mamma 1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No