The Mamma HiToP Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Verum group
|
Device: HiToP 191 PNP
High tone therapy
|
| Placebo Comparator: Placebo group
|
Device: Placebo device
Placebo therapy
|
Outcome Measures
Primary Outcome Measures
- Alleviation of paresthesias (VAS) [baseline vs. one day after the last treatment session]
Secondary Outcome Measures
- Further neuropathic symptoms (via VAS questionnaire) [baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session]
e.g., intensity of tightness, cramps
- Further neuropathic symptoms (via EORCT CIPN20 questionnaire) [baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session]
sensory, motor and autonomic scale
- Quality of life (via EORCT C30 questionnaire) [baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session]
global health status, physical function, symptom scales
Eligibility Criteria
Criteria
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
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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)
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Ability to walk (with or without aids)
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European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinics Donaustadt, Ottakring, Hietzing | Vienna | Austria |
Sponsors and Collaborators
- Vienna Hospital Association
Investigators
- Study Director: Tatjana Paternostro-Sluga, MD, Vienna Healthcare Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP_Mamma 1.1