The Mamma HiToP Study

Vienna Hospital Association160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Alleviation of paresthesias (VAS)

Visual analog scale, 0-10, higher score = worse

Time frame: baseline vs. one day after the last treatment session

Secondary Outcomes

Further neuropathic symptoms (via VAS questionnaire)

e.g., intensity of tightness, cramps, 0-10, higher score = worse

Time frame: 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, 1-4, higher score = worse

Time frame: 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, 1-4, higher score = worse

Time frame: baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session

The Mamma HiToP Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts