Clinical trial NCT02516540: Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer
Keywords: hereditary breast and ovarian cancer (HBOC)
BRCA1/2 mutation carriers
Mediterranean diet
Structured exercise training
prevention
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: University of Hohenheim
name: University Hospital Schleswig-Holstein
name: University of Leipzig
name: University of Cologne
First posted: 2015-08-06
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)
timeFrame: 12 months
measure: body mass index (BMI)
timeFrame: 12 months
measure: ventilatory threshold 1 (VT1) in spiroergometry
timeFrame: 12 months
Secondary outcomes:
measure: stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire
timeFrame: 3, 12, 24, 36 months
measure: grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire
timeFrame: 3, 12, 24, 36 months
measure: attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire
timeFrame: 3, 12, 24, 36 months
measure: quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: 3, 12, 24, 36 months
measure: maximum oxygen consumption (VO2max), as measured by spiroergometry
timeFrame: 3, 12 months
measure: physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)
timeFrame: 3, 12, 24, 36 months
measure: incidence of breast cancer
timeFrame: 12, 24, 36 months
measure: Mediterranean Diet Adherence Screener (MEDAS) Score
timeFrame: 3, 6, 9, 12, 24, 36 months
measure: body mass index (BMI)
timeFrame: 3, 12, 24, 36 months
measure: change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry
timeFrame: 3, 12 months
measure: mortality rate
timeFrame: 12, 24, 36 months
measure: satisfaction (questionnaire)
timeFrame: 3, 12, 24, 36 months
measure: tobacco consumption
timeFrame: 12, 24, 36 months
measure: alcohol consumption
timeFrame: 12, 24, 36 months
measure: dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ)
timeFrame: 3, 12, 24, 36 months
measure: serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin
timeFrame: 3, 12, 24, 36 months
measure: proenkephalin
timeFrame: 3, 12, 24, 36 months
measure: 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,
timeFrame: 3, 12, 24, 36 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Humboldt Universität zu Berlin
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinium Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Köln
country: Germany
facility: Uniklinikum Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: München
country: Germany
facility: Technische Universität München
city: Regensburg
country: Germany
facility: Universität Regensburg
city: Stuttgart
country: Germany
facility: Interdisziplinäres Brustzentrum am Diakonieklinikum
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universität Ulm
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: Technical University of Munich
name: Marion Kiechle, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Technical University of Munich
name: Martin Halle, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitaet Hohenheim, Stuttgart
name: Stephan C Bischoff, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University Hospital Schleswig-Holstein
name: Michael Siniatchkin, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Leipzig
name: Markus Loeffler, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Leipzig
name: Christoph Engel, PD Dr.
role: STUDY_DIRECTOR
affiliation: University of Cologne
name: Rita K Schmutzler, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Technical University of Munich
name: Alfons Meindl, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Technical University of Munich
name: Anne S Quante, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seethaler B, Nguyen NK, Basrai M, Kiechle M, Walter J, Delzenne NM, Bischoff SC. Short-chain fatty acids are key mediators of the favorable effects of the Mediterranean diet on intestinal barrier integrity: data from the randomized controlled LIBRE trial. Am J Clin Nutr. 2022 Oct 6;116(4):928-942. doi: 10.1093/ajcn/nqac175.
citation: Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff SC, Dukatz R, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Enders U, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:368. doi: 10.1186/s13063-016-1504-0.