The Mamma HiToP Study

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132776
• Other study ID #: CIP_Mamma 1.1
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Vienna Hospital Association
• Contact: Robert Wakolbinger-Habel, MD, PhD
• Phone: +43 1 28802 4604
• Email: robert.wakolbinger-habel[@]gesundheitsverbund.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: November 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• HiToP 191 PNP
High tone therapy
• Placebo device
Placebo therapy

Locations

Country	Name	City	State
Austria	Clinics Donaustadt, Ottakring, Hietzing	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Hospital Association

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alleviation of paresthesias (VAS)	Visual analog scale, 0-10, higher score = worse	baseline vs. one day after the last treatment session
Secondary	Further neuropathic symptoms (via VAS questionnaire)	e.g., intensity of tightness, cramps, 0-10, higher score = worse	baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
Secondary	Further neuropathic symptoms (via EORCT CIPN20 questionnaire)	sensory, motor and autonomic scale, 1-4, higher score = worse	baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
Secondary	Quality of life (via EORCT C30 questionnaire)	global health status, physical function, symptom scales, 1-4, higher score = worse	baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session