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, 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

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.

Keywords: BRCA1; BRCA2; Exercise; Hereditary breast cancer; Hereditary ovarian cancer; Mediterranean diet; Psychological support.

Conflict of interest statement

Ethics approval and consent to participate

Women shall participate in the study voluntarily and give written informed consent prior to study begin. They are informed that they can retract their participation at any time without disclosing any reasons and without negative consequences for their future medical care. The ethics review board of the Klinikum Rechts der Isar of the Technical University of Munich has approved the study protocol (Reference 5686/13) as well as the ethics committee of the faculty of Medicine of the University Cologne and Kiel (Reference 13-053 and Reference B 235/13). The study is planned and conducted in accordance with medical professional codex and the Helsinki Declaration of 1996 as well as the German Federal Data Protection Act (BDSG). The trial has been registered at Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram for LIBRE-1 pilot study [45]

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