Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Nov 10;17(1):752.
doi: 10.1186/s12885-017-3732-4.

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

Marion Kiechle  1 , Ricarda Dukatz  2 , Maryam Yahiaoui-Doktor  3 , Anika Berling  4 , Maryam Basrai  5 , Vera Staiger  5 , Uwe Niederberger  6 , Nicole Marter  6 , Jacqueline Lammert  2 , Sabine Grill  2 , Katharina Pfeifer  2 , Kerstin Rhiem  7 , Rita K Schmutzler  7 , Matthias Laudes  8 , Michael Siniatchkin  6 , Martin Halle  4   9 , Stephan C Bischoff  6 , Christoph Engel  3
Affiliations
Randomized Controlled Trial

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

Marion Kiechle et al. BMC Cancer. .

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.

PubMed Disclaimer

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 ClinicalTrials.gov (reference: NCT02087592).

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]
See this image and copyright information in PMC

References

    1. Mavaddat N, Pharoah PD, Michailidou K, Tyrer J, Brook MN, Bolla MK, et al. Prediction of breast cancer risk based on profiling with common genetic variants. J Natl Cancer Inst. 2015;107(5):djv036. doi:10.1093/jnci/djv036. - PMC - PubMed
    1. Mavaddat N, Peock S, Frost D, Ellis S, Platte R, Fineberg E, et al. Cancer risks for BRCA1 and BRCA2 mutation carriers: results from prospective analysis of EMBRACE. J Natl Cancer Inst. 2013;105(11):812–822. doi: 10.1093/jnci/djt095. - DOI - PubMed
    1. Easton DF, Pharoah PD, Antoniou AC, Tischkowitz M, Tavtigian SV, Nathanson KL, et al. Gene-panel sequencing and the prediction of breast-cancer risk. N Engl J Med. 2015;372(23):2243–2257. doi: 10.1056/NEJMsr1501341. - DOI - PMC - PubMed
    1. Antoniou AC, Kuchenbaecker KB, Soucy P, Beesley J, Chen X, McGuffog L, et al. Common variants at 12p11, 12q24, 9p21, 9q31.2 and in ZNF365 are associated with breast cancer risk for BRCA1 and/or BRCA2 mutation carriers. Breast cancer research : BCR. 2012;14(1):R33. doi: 10.1186/bcr3121. - DOI - PMC - PubMed
    1. Bissonauth V, Shatenstein B, Fafard E, Maugard C, Robidoux A, Narod S, et al. Weight history, smoking, physical activity and breast cancer risk among French-Canadian women non-carriers of more frequent BRCA1/2 mutations. Journal of cancer epidemiology. 2009;2009:748367. doi: 10.1155/2009/748367. - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data

Grants and funding