Clinical trial NCT06132776: The Mamma HiToP Study
Official title: High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Vienna Hospital Association
Sponsor class: OTHER_GOV
First posted: 2023-11-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Alleviation of paresthesias (VAS)
timeFrame: baseline vs. one day after the last treatment session
Secondary outcomes:
measure: Further neuropathic symptoms (via VAS questionnaire)
timeFrame: baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
measure: Further neuropathic symptoms (via EORCT CIPN20 questionnaire)
timeFrame: baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
measure: Quality of life (via EORCT C30 questionnaire)
timeFrame: baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clinics Donaustadt, Ottakring, Hietzing
Study officials:
affiliation: Vienna Healthcare Group
name: Tatjana Paternostro-Sluga, MD
role: STUDY_DIRECTOR
References: