Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
Marion Kiechle,
Ricarda Dukatz,
Maryam Yahiaoui-Doktor,
Anika Berling,
Maryam Basrai,
Vera Staiger,
Uwe Niederberger,
Nicole Marter,
Jacqueline Lammert,
Sabine Grill,
Katharina Pfeifer,
Kerstin Rhiem,
Rita K. Schmutzler,
Matthias Laudes,
Michael Siniatchkin,
Martin Halle,
Stephan C. Bischoff,
Christoph Engel
Affiliations
Marion Kiechle
Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM)
Ricarda Dukatz
Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM)
Maryam Yahiaoui-Doktor
Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig
Anika Berling
Department of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM)
Maryam Basrai
Institute for Nutritional Medicine, University Hohenheim
Vera Staiger
Institute for Nutritional Medicine, University Hohenheim
Uwe Niederberger
Institute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein
Nicole Marter
Institute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein
Jacqueline Lammert
Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM)
Sabine Grill
Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM)
Katharina Pfeifer
Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM)
Kerstin Rhiem
Center for Hereditary Breast and Ovarian Cancer, University Hospital Cologne
Rita K. Schmutzler
Center for Hereditary Breast and Ovarian Cancer, University Hospital Cologne
Matthias Laudes
Department of Internal Medicine 1, University Hospital Schleswig-Holstein
Michael Siniatchkin
Institute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein
Martin Halle
Department of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM)
Stephan C. Bischoff
Institute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein
Christoph Engel
Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig
Abstract Background Women 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. Methods We 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. Results Sixty-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. Conclusions This lifestyle intervention was feasible, safe and well accepted. Positive results on eating habits, physical fitness and stress levels warrant a larger randomized trial. Trial registration The study has been retrospectively registered at ClinicalTrials.gov (reference: NCT02087592 ) on March 12, 2014. The first patient was included on February 24, 2014.
