RecruitingNot ApplicableNCT02516540

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


Sponsor

Technical University of Munich

Enrollment

600 participants

Start Date

Mar 1, 2015

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lifestyle changes — including exercise and a Mediterranean-style diet — can improve health outcomes for women who carry the BRCA1 or BRCA2 gene mutation, which significantly raises the risk of breast and ovarian cancer. **You may be eligible if...** - You have a confirmed BRCA1 or BRCA2 gene mutation - You are 18 years of age or older - You are willing to sign a consent form **You may NOT be eligible if...** - You are currently receiving chemotherapy or radiation (though you may be eligible 6 weeks after finishing) - Your cancer has spread to other parts of the body (metastatic disease) - Your life expectancy is less than 3 years - You have serious heart or lung disease that limits physical activity - You have significant joint or bone problems that prevent group exercise - You have food allergies that would prevent following a Mediterranean diet, or you follow a vegan diet - You are pregnant - Your BMI is below 15 - You have insufficient knowledge of German - You are already actively participating in another intervention trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStructured exercise training plus mediterranean diet

Structured exercise training plus mediterranean diet


Locations(19)

Humboldt Universität zu Berlin

Berlin, Germany

Uniklinikum Köln

Cologne, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Kliniken Essen-Mitte

Essen, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinium Heidelberg

Heidelberg, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Technische Universität München

München, Germany

Universität Regensburg

Regensburg, Germany

Interdisziplinäres Brustzentrum am Diakonieklinikum

Stuttgart, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universität Ulm

Ulm, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

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NCT02516540


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