Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT02087592
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2014-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Sponsor:
Technical University of Munich
Organization:
Study Overview
Official Title:
Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations
Status:
COMPLETED
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:
LIBRE
Brief Summary:
BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter feasibility trial is that a structured life-style intervention program with exercise training and mediterranean diet is feasible and improves the nutritional and fitness status as well as the weight, the quality of life and stress reacting capacity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: