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Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers
RECRUITINGN/ASponsored by Technical University of Munich
Actively Recruiting
PhaseN/A
SponsorTechnical University of Munich
Started2015-03
Est. completion2025-03
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT02516540
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.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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
Conditions3
Breast CancerCancerHereditary Breast and Ovarian Cancer
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Actively Recruiting
PhaseN/A
SponsorTechnical University of Munich
Started2015-03
Est. completion2025-03
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT02516540