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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06132776
Other study ID # CIP_Mamma 1.1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2023
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Vienna Hospital Association
Contact Robert Wakolbinger-Habel, MD, PhD
Phone +43 1 28802 4604
Email robert.wakolbinger-habel@gesundheitsverbund.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 31, 2024
Est. primary completion date November 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HiToP 191 PNP
High tone therapy
Placebo device
Placebo therapy

Locations

Country Name City State
Austria Clinics Donaustadt, Ottakring, Hietzing Vienna

Sponsors (1)

Lead Sponsor Collaborator
Vienna Hospital Association

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alleviation of paresthesias (VAS) Visual analog scale, 0-10, higher score = worse baseline vs. one day after the last treatment session
Secondary Further neuropathic symptoms (via VAS questionnaire) e.g., intensity of tightness, cramps, 0-10, higher score = worse baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
Secondary Further neuropathic symptoms (via EORCT CIPN20 questionnaire) sensory, motor and autonomic scale, 1-4, higher score = worse baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
Secondary Quality of life (via EORCT C30 questionnaire) global health status, physical function, symptom scales, 1-4, higher score = worse baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
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