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

BMC Cancer

Kerstin Rhiem¹  Rita K. Schmutzler¹  Jacqueline Lammert²  Marion Kiechle²  Ricarda Dukatz²  Sabine Grill²  Katharina Pfeifer²  Matthias Laudes³  Anika Berling⁴  Martin Halle⁴  Maryam Yahiaoui-Doktor⁵  Christoph Engel⁵  Nicole Marter⁶  Uwe Niederberger⁶  Michael Siniatchkin⁶  Stephan C. Bischoff⁶  Vera Staiger⁷  Maryam Basrai⁷ 

[1] Center for Hereditary Breast and Ovarian Cancer, University Hospital Cologne;Department of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM);Department of Internal Medicine 1, University Hospital Schleswig-Holstein;Department of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM);Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig;Institute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein;Institute for Nutritional Medicine, University Hohenheim;

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

DOI  :  10.1186/s12885-017-3732-4

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown