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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

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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