Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2023-11-03
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Verum group
HiToP 191 PNP
High tone therapy
Placebo group
Placebo device
Placebo therapy
Interventions
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HiToP 191 PNP
High tone therapy
Placebo device
Placebo therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vienna Hospital Association
OTHER_GOV
Responsible Party
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Principal Investigators
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Tatjana Paternostro-Sluga, MD
Role: STUDY_DIRECTOR
Vienna Healthcare Group
Locations
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Clinics Donaustadt, Ottakring, Hietzing
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP_Mamma 1.1
Identifier Type: -
Identifier Source: org_study_id
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