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Trial Title:
The Mamma HiToP Study
NCT ID:
NCT06132776
Condition:
Chemotherapy-induced Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicenter, randomized, double-blind, placebo-controlled
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
HiToP 191 PNP
Description:
High tone therapy
Arm group label:
Verum group
Intervention type:
Device
Intervention name:
Placebo device
Description:
Placebo therapy
Arm group label:
Placebo group
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.
Criteria for eligibility:
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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinics Donaustadt, Ottakring, Hietzing
Address:
City:
Vienna
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Robert Wakolbinger-Habel, MD, PhD
Phone:
+43 1 28802
Phone ext:
4604
Email:
robert.wakolbinger-habel@gesundheitsverbund.at
Contact backup:
Last name:
Brigitte E Scheffold, MD, MSc, MSc
Phone:
+43 1 28802
Phone ext:
4604
Email:
brigitteelisabeth.scheffold@gesundheitsverbund.at
Start date:
November 3, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Vienna Hospital Association
Agency class:
Other
Source:
Vienna Hospital Association
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06132776
