Status:
RECRUITING
The Mamma HiToP Study
Lead Sponsor:
Vienna Hospital Association
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 subje...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06132776
Start Date
November 3 2023
End Date
December 31 2024
Last Update
April 26 2024
Active Locations (1)
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1
Clinics Donaustadt, Ottakring, Hietzing
Vienna, Austria