C50 C56
Conditions
Interventions
Group 1: Usual standard of care
Group 2: Usual standard of care plus 3-month structured physical exercise training plus mediterranean-style diet
Sponsors
Klinikum rechts der Isar der TU München, Frauenklinik
Eligibility
Sex/Gender
Female
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: Women with proven pathogenic BRCA1/2 mutation
Exclusion criteria
Exclusion criteria: metastatic tumor disease, life expectancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients successfully completing the intervention program | — |
Secondary
| Measure | Time frame |
|---|---|
| Stress coping capacity (TICS), Grade of optimism (LOT), Body Mass Index (BMI) as a marker for caloric balance, Total fat intake, Maximal Exercise Capacity (maximal oxygen consumption, VO2max) as a marker for physical fitness, physical activity (IPAQ), Quality of life (SF-36), all evaluated after 3, 12, 24, 36 months compared with baseline | — |
Countries
Germany
Contacts
Public ContactSabine Brandhorst
FrauenklinikKlinikum Rechts der IsarTechnischen Universität München (TUM)
Outcome results
None listed