Clinical Trial: Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Randomized Multicenter Trial to Assess the Efficacy of a Structured Physical Exercise Training and Mediterranean Diet in Women With BRCA1/2 Mutations

Brief 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.

Detailed Summary: BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. 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.
Sponsor: Technische Universität München

Current Primary Outcome:

  • Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire) [ Time Frame: 12 months ]
    Adherence to mediterranean diet
  • body mass index (BMI) [ Time Frame: 12 months ]
  • ventilatory threshold 1 (VT1) in spiroergometry [ Time Frame: 12 months ]
    ventilatory threshold VT1 in spiroergometry


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire [ Time Frame: 3, 12, 24, 36 months ]
  • grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire [ Time Frame: 3, 12, 24, 36 months ]
  • attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire [ Time Frame: 3, 12, 24, 36 months ]
  • quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: 3, 12, 24, 36 months ]
  • maximum oxygen consumption (VO2max), as measured by spiroergometry [ Time Frame: 3, 12 months ]
  • physical activity, as measured by the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 3, 12, 24, 36 months ]
  • incidence of breast cancer [ Time Frame: 12, 24, 36 months ]
  • Mediterranean Diet Adherence Screener (MEDAS) Score [ Time Frame: 3, 6, 9, 12, 24, 36 months ]
  • body mass index (BMI) [ Time Frame: 3, 12, 24, 36 months ]
  • change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry [ Time Frame: 3, 12 months ]
  • mortality rate [ Time Frame: 12, 24, 36 months ]
  • satisfaction (questionnaire) [ Time Frame: 3, 12, 24, 36 months ]
  • tobacco consumption [ Time Frame: 12, 24, 36 months ]
  • alcohol consumption [ Time Frame: 12, 24, 36 months ]
  • dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ) [ Time Frame: 3, 12, 24, 36 months ]
  • Omega 3 fatty acid in the erythrocyte membrane [ Time Frame: 3, 12, 24, 36 months ]
  • Omega 6 fatty acid level in the erythrocyte membrane [ Time Frame: 3, 12, 24, 36 months ]
  • Omega 9 fatty acid level in the erythrocyte membrane [ Time Frame: 3, 12, 24, 36 months ]
  • serum cholesterol [ Time Frame: 3, 12, 24, 36 months ]
  • serum high density lipoprotein cholesterol [ Time Frame: 3, 12, 24, 36 months ]
  • serum low density lipoprotein cholesterol [ Time Frame: 3, 12, 24, 36 months ]
  • serum triglycerides [ Time Frame: 3, 12, 24, 36 months ]
  • serum glucose [ Time Frame: 3, 12, 24, 36 months ]
  • c-reactive protein [ Time Frame: 3, 12, 24, 36 months ]
  • serum insulin [ Time Frame: 3, 12, 24, 36 months ]
  • body fat content, as measured by skin folds measurement [ Time Frame: 3, 12, 24, 36 months ]
  • proenkephalin [ Time Frame: 3, 12, 24, 36 months ]
  • proneurotensin [ Time Frame: 3, 12, 24, 36 months ]


Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: July 22, 2015
Date Started: March 2015
Date Completion: October 2021
Last Updated: April 27, 2017
Last Verified: April 2017