Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE-2)
Hereditary Breast and Ovarian Cancer
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
No Intervention
Experimental
Control
Intervention
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.