The Mamma HiToP Study

Vienna Hospital Association

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: HiToP 191 PNP; Device: Placebo device

Study type: Interventional

Funder types: Other

Identifiers

NCT06132776

CIP_Mamma 1.1

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Verum group

Experimental group

Treatment:

Device: HiToP 191 PNP

Placebo group

Placebo Comparator group

Treatment:

Device: Placebo device