Trials / Recruiting
RecruitingNCT06132776
The Mamma HiToP Study
High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Vienna Hospital Association · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HiToP 191 PNP | High tone therapy |
| DEVICE | Placebo device | Placebo therapy |
Timeline
- Start date
- 2023-11-03
- Primary completion
- 2024-11-02
- Completion
- 2024-12-31
- First posted
- 2023-11-15
- Last updated
- 2024-04-26
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT06132776. Inclusion in this directory is not an endorsement.