Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)

BMC Cancer

Research Article

Rita K. Schmutzler¹  Kerstin Rhiem¹  Sabine Grill²  Jacqueline Lammert²  Ricarda Dukatz²  Marion Kiechle²  Katharina Pfeifer²  Matthias Laudes³  Anika Berling⁴  Martin Halle⁵  Christoph Engel⁶  Maryam Yahiaoui-Doktor⁶  Michael Siniatchkin⁷  Nicole Marter⁷  Stephan C. Bischoff⁷  Uwe Niederberger⁷  Vera Staiger⁸  Maryam Basrai⁸ 

[1] Center for Hereditary Breast and Ovarian Cancer, University Hospital Cologne, Kerpener Str. 34, 50931, Cologne, Germany;Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675, Munich, Germany;Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, Arnold-Heller-Strasse 3, 24105, Kiel, Germany;Department of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM), Georg-Brauchle Ring 56, 80638, Munich, Germany;Department of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM), Georg-Brauchle Ring 56, 80638, Munich, Germany;Else Kroener-Fresenius Prevention Center, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675, Munich, Germany;Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Haertelstrasse 16-18, 04107, Leipzig, Germany;Institute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein, Campus Kiel, Preusserstr. 1 - 9, 24105, Kiel, Germany;Institute for Nutritional Medicine, University Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany;

关键词: BRCA1;    BRCA2;    Hereditary breast cancer;    Hereditary ovarian cancer;    Exercise;    Mediterranean diet;    Psychological support;   

DOI  :  10.1186/s12885-017-3732-4

 received in 2017-01-25, accepted in 2017-10-30,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundWomen with pathogenic BRCA germline mutations have an increased risk for breast and ovarian cancer that seems to be modified by life-style factors. Though, randomized trials investigating the impact of lifestyle interventions on cancer prevention and prognosis in BRCA carriers are still missing.MethodsWe implemented a multicenter, prospective randomized controlled trial in BRCA1/2 patients, comparing a lifestyle intervention group (IG) with a control group (CG) with the primary aim to prove feasibility. Intervention comprised a structured, individualized endurance training alongside nutrition education based on the Mediterranean diet (MD) for 3 months, plus monthly group training and regular telephone contact during the subsequent 9 months. The CG attended one session on healthy nutrition and the benefits of physical activity. Primary endpoints were feasibility, acceptance and satisfaction over 12 months. Furthermore, effects on physical fitness, diet profile, body mass index (BMI), quality of life and perceived stress were investigated.ResultsSixty-eight participants (mean age 41, mean BMI 23.2 kg/m2) were enrolled, of whom 55 (81%, 26 IG, 29 CG) completed 12 months. 73% (n = 26) participated in at least 70% of all intervention sessions. Predictors for drop-outs (19%; n = 13) or non-adherence (27%; n = 7) were not found. 73% rated the program highly and 80% would participate again. Severe adverse events did not occur. Positive effects in the IG compared to the CG were observed for secondary endpoints: BMI, MD eating pattern and stress levels.ConclusionsThis lifestyle intervention was feasible, safe and well accepted. Positive results on eating habits, physical fitness and stress levels warrant a larger randomized trial.Trial registrationThe study has been retrospectively registered at ClinicalTrials.gov (reference: NCT02087592) on March 12, 2014. The first patient was included on February 24, 2014.

【 授权许可】

CC BY   
© The Author(s). 2017