Back to resultsFeasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE)
Primary Purpose
Hereditary Breast and Ovarian Cancer
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Structured exercise training plus mediterranean diet
Sponsored by
About this trial
This is an interventional prevention trial for Hereditary Breast and Ovarian Cancer focused on measuring hereditary breast and ovarian cancer (HBOC), BRCA1/2 mutation carriers, Mediterranean diet, Structured exercise training, prevention
Eligibility Criteria
Inclusion Criteria:
- women with proven pathogenic BRCA1/2 mutation
Exclusion Criteria:
- metastatic tumor disease
- life expectancy <3 years
- clinically limiting cardiovascular or respiratory disease
- significant orthopedic disability which prevents from participating in the exercise training
- severe concomitant disease which prevents from participating in the group interventions
- Karnofsky index <60
- VO2max >150%
- Maximal exercise capacity < 50 W
- food allergies which prevent from mediterranean diet
- vegan diet
- body mass index <15 kg/m2
- pregnancy
- insufficient knowledge of German language
- insufficient compliance
- active participation in other interventional trials
- no informed consent
Sites / Locations
- University of Cologne
- University of Schleswig-Holstein Campus Kiel
- Technische Universitaet Muenchen
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Usual standard of care
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
Outcomes
Primary Outcome Measures
Number of patients successfully completing the intervention program
Secondary Outcome Measures
Stress coping capacity (TICS)
Grade of optimism (LOT)
Body mass index as a marker of caloric balance
Total fat intake
maximum exercise capacity (VO2max) as a marker of physical fitness
Quality of life (SF-36)
Physical activity (IPAQ questionnaire)
Full Information
NCT ID
NCT02087592
First Posted
March 12, 2014
Last Updated
October 25, 2022
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT02087592
Brief Title
Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Acronym
LIBRE
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2014 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast and Ovarian Cancer
Keywords
hereditary breast and ovarian cancer (HBOC), BRCA1/2 mutation carriers, Mediterranean diet, Structured exercise training, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual standard of care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise training plus mediterranean diet
Primary Outcome Measure Information:
Title
Number of patients successfully completing the intervention program
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Stress coping capacity (TICS)
Time Frame
3 months
Title
Grade of optimism (LOT)
Time Frame
3 months
Title
Body mass index as a marker of caloric balance
Time Frame
3 months
Title
Total fat intake
Time Frame
3 months
Title
maximum exercise capacity (VO2max) as a marker of physical fitness
Time Frame
3 months
Title
Quality of life (SF-36)
Time Frame
3 months
Title
Physical activity (IPAQ questionnaire)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Anthropometric parameters (waist and hip circumference, skinfold measurements)
Time Frame
3 months
Title
Body composition (body impedance analysis)
Time Frame
3 months
Title
Eating behaviour
Time Frame
3 months
Title
Laboratory parameters
Time Frame
3 months
Title
Aerobic exercise capacity during ergometry
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with proven pathogenic BRCA1/2 mutation
Exclusion Criteria:
metastatic tumor disease
life expectancy <3 years
clinically limiting cardiovascular or respiratory disease
significant orthopedic disability which prevents from participating in the exercise training
severe concomitant disease which prevents from participating in the group interventions
Karnofsky index <60
VO2max >150%
Maximal exercise capacity < 50 W
food allergies which prevent from mediterranean diet
vegan diet
body mass index <15 kg/m2
pregnancy
insufficient knowledge of German language
insufficient compliance
active participation in other interventional trials
no informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Kiechle, Prof. Dr.
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Halle, Prof. Dr.
Organizational Affiliation
Technical University of Munich
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephan C Bischoff, Prof. Dr.
Organizational Affiliation
Universitaet Hohenheim, Stuttgart
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wolf-Dieter Gerber, Prof. Dr.
Organizational Affiliation
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Markus Loeffler, Prof. Dr.
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christoph Engel, Dr.
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rita K Schmutzler, Prof. Dr.
Organizational Affiliation
University of Cologne
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alfons Meindl, Prof. Dr.
Organizational Affiliation
Technical University of Munich
Official's Role
Study Director
Facility Information:
Facility Name
University of Cologne
City
Cologne
Country
Germany
Facility Name
University of Schleswig-Holstein Campus Kiel
City
Kiel
Country
Germany
Facility Name
Technische Universitaet Muenchen
City
Munich
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
36055959
Citation
Seethaler B, Nguyen NK, Basrai M, Kiechle M, Walter J, Delzenne NM, Bischoff SC. Short-chain fatty acids are key mediators of the favorable effects of the Mediterranean diet on intestinal barrier integrity: data from the randomized controlled LIBRE trial. Am J Clin Nutr. 2022 Oct 6;116(4):928-942. doi: 10.1093/ajcn/nqac175.
Results Reference
derived
PubMed Identifier
35190584
Citation
Berling-Ernst A, Yahiaoui-Doktor M, Kiechle M, Engel C, Lammert J, Grill S, Dukatz R, Rhiem K, Baumann FT, Bischoff SC, Erickson N, Schmidt T, Niederberger U, Siniatchkin M, Halle M. Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1). Sci Rep. 2022 Feb 21;12(1):2907. doi: 10.1038/s41598-022-06913-1.
Results Reference
derived
PubMed Identifier
31735538
Citation
Seethaler B, Basrai M, Vetter W, Lehnert K, Engel C, Siniatchkin M, Halle M, Kiechle M, Bischoff SC. Fatty acid profiles in erythrocyte membranes following the Mediterranean diet - data from a multicenter lifestyle intervention study in women with hereditary breast cancer (LIBRE). Clin Nutr. 2020 Aug;39(8):2389-2398. doi: 10.1016/j.clnu.2019.10.033. Epub 2019 Nov 2.
Results Reference
derived
PubMed Identifier
29126396
Citation
Kiechle M, Dukatz R, Yahiaoui-Doktor M, Berling A, Basrai M, Staiger V, Niederberger U, Marter N, Lammert J, Grill S, Pfeifer K, Rhiem K, Schmutzler RK, Laudes M, Siniatchkin M, Halle M, Bischoff SC, Engel C. Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers - an interventional randomized controlled multicenter trial (LIBRE-1). BMC Cancer. 2017 Nov 10;17(1):752. doi: 10.1186/s12885-017-3732-4.
Results Reference
derived
PubMed Identifier
28521737
Citation
Hebestreit K, Yahiaoui-Doktor M, Engel C, Vetter W, Siniatchkin M, Erickson N, Halle M, Kiechle M, Bischoff SC. Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. BMC Cancer. 2017 May 18;17(1):341. doi: 10.1186/s12885-017-3337-y.
Results Reference
derived
PubMed Identifier
28031860
Citation
Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff S, Dukatz R, Gerber WD, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Marter N, Enders U, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study). Pilot Feasibility Stud. 2016 Dec 19;2:74. doi: 10.1186/s40814-016-0114-7. eCollection 2016.
Results Reference
derived
Links:
URL
http://www.frauenklinik.med.tum.de/
Description
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Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
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