Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Prospective Randomized Multicenter Trial to Assess the Efficacy of a Structured Physical Exercise Training and Mediterranean Diet in Women With BRCA1/2 Mutations

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.

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.

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