Hereditary Breast and Ovarian Cancer
Conditions
Keywords
hereditary breast and ovarian cancer (HBOC), BRCA1/2 mutation carriers, Mediterranean diet, Structured exercise training, prevention
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.
Interventions
Structured exercise training plus mediterranean diet
Sponsors
University of Hohenheim
University Hospital Schleswig-Holstein
University of Leipzig
University of Cologne
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* proven pathogenic BRCA1/2 mutation * age \>=18 * written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire) | 12 months | Adherence to mediterranean diet |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| maximum oxygen consumption (VO2max), as measured by spiroergometry | 3, 12 months | spiroergometry |
| 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 |
| body mass index (BMI) | 3, 12, 24, 36 months | (BMI) |
| change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry | 3, 12 months | spiroergometry |
| stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire | 3, 12, 24, 36 months | (TICS) questionnaire |
| satisfaction (questionnaire) | 3, 12, 24, 36 months | satisfaction (questionnaire) |
| 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 |
| 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 |
| mortality rate | 12, 24, 36 months | During study |
| 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 |
Countries
Germany
Contacts
Primary ContactMarion Kiechle, Prof. Dr.
Backup ContactDaniela Schemmer
Outcome results
None listed