Back to resultsEfficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE-2)
Primary Purpose
Hereditary Breast and Ovarian Cancer
Status
Recruiting
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:
- proven pathogenic BRCA1/2 mutation
- age >=18
- written informed consent
Exclusion Criteria:
- current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
- metastatic tumor disease
- life expectancy <3 years
- clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
- significant orthopedic disability which prevents from participating in the group interventions
- severe concomitant diseases which prevents from participating in the group interventions
- Karnofsky index <60
- maximum 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
Sites / Locations
- Humboldt Universität zu BerlinRecruiting
- Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenRecruiting
- Universitätsklinikum DüsseldorfRecruiting
- Kliniken Essen-MitteRecruiting
- Universitätsklinikum EssenRecruiting
- Universitätsklinikum FreiburgRecruiting
- Universitätsmedizin GöttingenRecruiting
- Universitätsklinikum Hamburg-EppendorfRecruiting
- Medizinische Hochschule HannoverRecruiting
- Universitätsklinium HeidelbergRecruiting
- Universitätsklinikum Schleswig-Holstein, Campus KielRecruiting
- Uniklinikum KölnRecruiting
- Universitätsklinikum Leipzig
- Technische Universität MünchenRecruiting
- Universität RegensburgRecruiting
- Interdisziplinäres Brustzentrum am DiakonieklinikumRecruiting
- Universitätsklinikum TübingenRecruiting
- Universität UlmRecruiting
- Universitätsklinikum WürzburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Study participants are instructed regarding a healthy diet according to the recommendations of the German Nutrition Society (DGE) and are informed about positive effects of physical activity on incidence and prognosis of breast cancer
Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet.
Outcomes
Primary Outcome Measures
Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)
Adherence to mediterranean diet
body mass index (BMI)
Body weight (in kilograms) divided by body height (in meters) squared.
ventilatory threshold 1 (VT1) in spiroergometry
ventilatory threshold VT1 in spiroergometry
Secondary Outcome Measures
stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire
(TICS) questionnaire
grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire
Life Orientation Test (LOT)
attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire
(BKAE) questionnaire
quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
(EORTC QLQ-C30)
maximum oxygen consumption (VO2max), as measured by spiroergometry
spiroergometry
physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)
Physical Activity
incidence of breast cancer
During study
Mediterranean Diet Adherence Screener (MEDAS) Score
(MEDAS) Score
body mass index (BMI)
(BMI)
change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry
spiroergometry
mortality rate
During study
satisfaction (questionnaire)
satisfaction (questionnaire)
tobacco consumption
survey
alcohol consumption
survey
dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ)
(EPIC-FFQ)
serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin
Blood Test
proenkephalin
Genetic test
Omega 3 fatty acid in the erythrocyte Membrane, Omega 6 fatty acid level in the erythrocyte Membraserum low density, lipoprotein cholesterolne, Omega 9 fatty acid level in the erythrocyte Membrane,
Blood Test
Full Information
NCT ID
NCT02516540
First Posted
July 22, 2015
Last Updated
October 25, 2022
Sponsor
Technical University of Munich
Collaborators
University of Hohenheim, University Hospital Schleswig-Holstein, University of Leipzig, University of Cologne
1. Study Identification
Unique Protocol Identification Number
NCT02516540
Brief Title
Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Acronym
LIBRE-2
Official Title
Prospective Randomized Multicenter Trial to Assess the Efficacy of a Structured Physical Exercise Training and Mediterranean Diet in Women With BRCA1/2 Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
University of Hohenheim, University Hospital Schleswig-Holstein, University of Leipzig, University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.
Detailed Description
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 efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.
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
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Study participants are instructed regarding a healthy diet according to the recommendations of the German Nutrition Society (DGE) and are informed about positive effects of physical activity on incidence and prognosis of breast cancer
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet.
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise training plus mediterranean diet
Intervention Description
Structured exercise training plus mediterranean diet
Primary Outcome Measure Information:
Title
Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)
Description
Adherence to mediterranean diet
Time Frame
12 months
Title
body mass index (BMI)
Description
Body weight (in kilograms) divided by body height (in meters) squared.
Time Frame
12 months
Title
ventilatory threshold 1 (VT1) in spiroergometry
Description
ventilatory threshold VT1 in spiroergometry
Time Frame
12 months
Secondary Outcome Measure Information:
Title
stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire
Description
(TICS) questionnaire
Time Frame
3, 12, 24, 36 months
Title
grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire
Description
Life Orientation Test (LOT)
Time Frame
3, 12, 24, 36 months
Title
attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire
Description
(BKAE) questionnaire
Time Frame
3, 12, 24, 36 months
Title
quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
(EORTC QLQ-C30)
Time Frame
3, 12, 24, 36 months
Title
maximum oxygen consumption (VO2max), as measured by spiroergometry
Description
spiroergometry
Time Frame
3, 12 months
Title
physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)
Description
Physical Activity
Time Frame
3, 12, 24, 36 months
Title
incidence of breast cancer
Description
During study
Time Frame
12, 24, 36 months
Title
Mediterranean Diet Adherence Screener (MEDAS) Score
Description
(MEDAS) Score
Time Frame
3, 6, 9, 12, 24, 36 months
Title
body mass index (BMI)
Description
(BMI)
Time Frame
3, 12, 24, 36 months
Title
change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry
Description
spiroergometry
Time Frame
3, 12 months
Title
mortality rate
Description
During study
Time Frame
12, 24, 36 months
Title
satisfaction (questionnaire)
Description
satisfaction (questionnaire)
Time Frame
3, 12, 24, 36 months
Title
tobacco consumption
Description
survey
Time Frame
12, 24, 36 months
Title
alcohol consumption
Description
survey
Time Frame
12, 24, 36 months
Title
dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ)
Description
(EPIC-FFQ)
Time Frame
3, 12, 24, 36 months
Title
serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin
Description
Blood Test
Time Frame
3, 12, 24, 36 months
Title
proenkephalin
Description
Genetic test
Time Frame
3, 12, 24, 36 months
Title
Omega 3 fatty acid in the erythrocyte Membrane, Omega 6 fatty acid level in the erythrocyte Membraserum low density, lipoprotein cholesterolne, Omega 9 fatty acid level in the erythrocyte Membrane,
Description
Blood Test
Time Frame
3, 12, 24, 36 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
proven pathogenic BRCA1/2 mutation
age >=18
written informed consent
Exclusion Criteria:
current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
metastatic tumor disease
life expectancy <3 years
clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
significant orthopedic disability which prevents from participating in the group interventions
severe concomitant diseases which prevents from participating in the group interventions
Karnofsky index <60
maximum 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Kiechle, Prof. Dr.
Phone
+49 89 4140 2420
Email
marion.kiechle@tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Schemmer
Phone
+49 89 4140 2433
Email
Daniela.Schemmer@mri.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Kiechle, Prof. Dr.
Organizational Affiliation
Technical University of Munich
Official's Role
Study Director
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
Michael Siniatchkin, Prof. Dr.
Organizational Affiliation
Universitätsklinikum 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, PD 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
First Name & Middle Initial & Last Name & Degree
Anne S Quante, Dr.
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humboldt Universität zu Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken Essen-Mitte
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinium Heidelberg
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Name
Uniklinikum Köln
City
Köln
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Technische Universität München
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universität Regensburg
City
Regensburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Interdisziplinäres Brustzentrum am Diakonieklinikum
City
Stuttgart
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universität Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Individual Site Status
Recruiting
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
27473440
Citation
Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff SC, Dukatz R, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Enders U, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:368. doi: 10.1186/s13063-016-1504-0.
Results Reference
derived
Learn more about this trial
Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers
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