Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02087592 |
Recruitment Status :
Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : October 26, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hereditary Breast and Ovarian Cancer | Behavioral: Structured exercise training plus mediterranean diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | February 2014 |
Actual Primary Completion Date : | November 2014 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
Usual standard of care
|
|
Experimental: Intervention
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
|
Behavioral: Structured exercise training plus mediterranean diet |
- Number of patients successfully completing the intervention program [ Time Frame: 3 months ]
- Stress coping capacity (TICS) [ Time Frame: 3 months ]
- Grade of optimism (LOT) [ Time Frame: 3 months ]
- Body mass index as a marker of caloric balance [ Time Frame: 3 months ]
- Total fat intake [ Time Frame: 3 months ]
- maximum exercise capacity (VO2max) as a marker of physical fitness [ Time Frame: 3 months ]
- Quality of life (SF-36) [ Time Frame: 3 months ]
- Physical activity (IPAQ questionnaire) [ Time Frame: 3 months ]
- Anthropometric parameters (waist and hip circumference, skinfold measurements) [ Time Frame: 3 months ]
- Body composition (body impedance analysis) [ Time Frame: 3 months ]
- Eating behaviour [ Time Frame: 3 months ]
- Laboratory parameters [ Time Frame: 3 months ]
- Aerobic exercise capacity during ergometry [ Time Frame: 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087592
Germany | |
University of Cologne | |
Cologne, Germany | |
University of Schleswig-Holstein Campus Kiel | |
Kiel, Germany | |
Technische Universitaet Muenchen | |
Munich, Germany |
Principal Investigator: | Marion Kiechle, Prof. Dr. | Technical University of Munich | |
Study Director: | Martin Halle, Prof. Dr. | Technical University of Munich | |
Study Director: | Stephan C Bischoff, Prof. Dr. | Universitaet Hohenheim, Stuttgart | |
Study Director: | Wolf-Dieter Gerber, Prof. Dr. | Universitaetsklinikum Schleswig-Holstein, Campus Kiel | |
Study Director: | Markus Loeffler, Prof. Dr. | University of Leipzig | |
Study Director: | Christoph Engel, Dr. | University of Leipzig | |
Study Director: | Rita K Schmutzler, Prof. Dr. | University of Cologne | |
Study Director: | Alfons Meindl, Prof. Dr. | Technical University of Munich |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Technical University of Munich |
ClinicalTrials.gov Identifier: | NCT02087592 |
Other Study ID Numbers: |
LIBRE-F-110013 |
First Posted: | March 14, 2014 Key Record Dates |
Last Update Posted: | October 26, 2022 |
Last Verified: | October 2022 |
hereditary breast and ovarian cancer (HBOC) BRCA1/2 mutation carriers Mediterranean diet Structured exercise training prevention |
Ovarian Neoplasms Hereditary Breast and Ovarian Cancer Syndrome Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Breast Neoplasms Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Breast Diseases Skin Diseases |