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Klinische Studien

Libre-2

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
NCT02516540DRKS00009629

Prospective randomized multicentre study of the efficacy of a structured exercise program and Mediterranean diet in women with BRCA1 / 2 mutations

Status: Active

Purpose / Objectives

Primary Outcome

Proof of enhancement of a Mediterranean diet (MEDAS score), a reduction in body weight (BMI) and an increase in physical fitness (improvement in oxygen uptake VO2 at the ventilatory threshold VT1 in spiroergometry.

Secondary Outcomes

Evidence of improving quality of life and coping with stress as well as changing attitudes and beliefs about exercise and healthy eating, reducing breast cancer incidence.

Diagnosis

Patient attributes

Age

18-70

Inclusion criteria

Carrier of BRCA1/BRCA2 mutation

Exclusion criteria

  • <18 years    
  • Karnofsky Index <60%    
  • Max. Body. Load capacity<50 watts   
  •  pregnancy   
  •  Significant orthopedic problems that do not allow exercise training    
  • Inadequate knowledge of the German language   
  •  Lack of cooperation (compliance)    
  • Metastatic tumors  
  •   No current chemo- and radiotherapy

Trial design

  • Multicenter
  • Randomized
  • Two-arm
  • Open Label

Intervention

The intervention group will receive a 12-month lifestyle intervention, which will be intensified in the first 3 months and maintained and monitored through monthly contacts and meetings for the following 9 months. The lifestyle intervention includes a structured intensified training based on the results of the performance diagnostics and a nutrition program based on the Mediterranean diet.

Miscellaneous

Control group: At the beginning of the study, a healthy diet training according to the DGE recommendations and the education about the positive effects of physical activity on the incidence and prognosis of breast cancer will take place.

Documents (password protected)

Responsibilities in overall trial

Technische Universität München

    Study Sites

    Klinik für Frauenheilkunde und Geburtshilfe

    Study office

    Status

    Active

    Principal Investigator

    Dr. med. Anne-Sophie Vesper

    Contact at Site

    Zentrum Familiärer Brust- und Eierstockkrebs

    Study office

    • Zentrum Familiärer Brust- und Eierstockkrebs

    Status

    Active

    Principal Investigator

    Prof. Dr. med. Rita K. Schmutzler

    Deputy of Principal Investigator

    • Prof. Dr. med. Kerstin Rhiem

    Subinvestigator

    • DR. Natalie Herold
    • Annette Hübbel

    Contact at Site

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