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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

Hereditary Breast and Ovarian Cancer

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

Inclusion Criteria3

  • proven pathogenic BRCA1/2 mutation
  • age \>=18
  • written informed consent

Exclusion Criteria15

  • 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

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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