Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers
- Conditions
- Hereditary Breast and Ovarian Cancer
- Interventions
- Behavioral: Structured exercise training plus mediterranean diet
- Registration Number
- NCT02516540
- Lead Sponsor
- Technical University of Munich
- 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 Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 600
- proven pathogenic BRCA1/2 mutation
- age >=18
- written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Structured exercise training plus mediterranean diet Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet.
- Primary Outcome Measures
Name Time Method body mass index (BMI) 12 months Body weight (in kilograms) divided by body height (in meters) squared.
ventilatory threshold 1 (VT1) in spiroergometry 12 months ventilatory threshold VT1 in spiroergometry
Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire) 12 months Adherence to mediterranean diet
- Secondary Outcome Measures
Name Time Method stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire 3, 12, 24, 36 months (TICS) questionnaire
maximum oxygen consumption (VO2max), as measured by spiroergometry 3, 12 months spiroergometry
body mass index (BMI) 3, 12, 24, 36 months (BMI)
satisfaction (questionnaire) 3, 12, 24, 36 months satisfaction (questionnaire)
physical activity, as measured by the International Physical Activity Questionnaire (IPAQ) 3, 12, 24, 36 months Physical Activity
incidence of breast cancer 12, 24, 36 months During study
Mediterranean Diet Adherence Screener (MEDAS) Score 3, 6, 9, 12, 24, 36 months (MEDAS) Score
Omega 3 fatty acid in the erythrocyte Membrane, Omega 6 fatty acid level in the erythrocyte Membraserum low density, lipoprotein cholesterolne, Omega 9 fatty acid level in the erythrocyte Membrane, 3, 12, 24, 36 months Blood Test
grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire 3, 12, 24, 36 months Life Orientation Test (LOT)
attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire 3, 12, 24, 36 months (BKAE) questionnaire
quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) 3, 12, 24, 36 months (EORTC QLQ-C30)
change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry 3, 12 months spiroergometry
mortality rate 12, 24, 36 months During study
tobacco consumption 12, 24, 36 months survey
alcohol consumption 12, 24, 36 months survey
dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ) 3, 12, 24, 36 months (EPIC-FFQ)
serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin 3, 12, 24, 36 months Blood Test
proenkephalin 3, 12, 24, 36 months Genetic test
Trial Locations
- Locations (19)
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Humboldt Universität zu Berlin
🇩🇪Berlin, Germany
Kliniken Essen-Mitte
🇩🇪Essen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universität Regensburg
🇩🇪Regensburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universität Ulm
🇩🇪Ulm, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Uniklinikum Köln
🇩🇪Köln, Germany
Technische Universität München
🇩🇪München, Germany
Interdisziplinäres Brustzentrum am Diakonieklinikum
🇩🇪Stuttgart, Germany
Universitätsklinium Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany