Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132776
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-11-03
Brief Title:
The Mamma HiToP Study
Sponsor:
Vienna Hospital Association
Organization:
Vienna Hospital Association
Study Overview
Official Title:
High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None