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

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...

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Autores principales: Kiechle, Marion, Dukatz, Ricarda, Yahiaoui-Doktor, Maryam, Berling, Anika, Basrai, Maryam, Staiger, Vera, Niederberger, Uwe, Marter, Nicole, Lammert, Jacqueline, Grill, Sabine, Pfeifer, Katharina, Rhiem, Kerstin, Schmutzler, Rita K., Laudes, Matthias, Siniatchkin, Michael, Halle, Martin, Bischoff, Stephan C., Engel, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681801/
https://www.ncbi.nlm.nih.gov/pubmed/29126396
http://dx.doi.org/10.1186/s12885-017-3732-4
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author Kiechle, Marion
Dukatz, Ricarda
Yahiaoui-Doktor, Maryam
Berling, Anika
Basrai, Maryam
Staiger, Vera
Niederberger, Uwe
Marter, Nicole
Lammert, Jacqueline
Grill, Sabine
Pfeifer, Katharina
Rhiem, Kerstin
Schmutzler, Rita K.
Laudes, Matthias
Siniatchkin, Michael
Halle, Martin
Bischoff, Stephan C.
Engel, Christoph
author_facet Kiechle, Marion
Dukatz, Ricarda
Yahiaoui-Doktor, Maryam
Berling, Anika
Basrai, Maryam
Staiger, Vera
Niederberger, Uwe
Marter, Nicole
Lammert, Jacqueline
Grill, Sabine
Pfeifer, Katharina
Rhiem, Kerstin
Schmutzler, Rita K.
Laudes, Matthias
Siniatchkin, Michael
Halle, Martin
Bischoff, Stephan C.
Engel, Christoph
author_sort Kiechle, Marion
collection PubMed
description 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/m(2)) 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.
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spelling pubmed-56818012017-11-17 Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1) Kiechle, Marion Dukatz, Ricarda Yahiaoui-Doktor, Maryam Berling, Anika Basrai, Maryam Staiger, Vera Niederberger, Uwe Marter, Nicole Lammert, Jacqueline Grill, Sabine Pfeifer, Katharina Rhiem, Kerstin Schmutzler, Rita K. Laudes, Matthias Siniatchkin, Michael Halle, Martin Bischoff, Stephan C. Engel, Christoph BMC Cancer Research Article 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/m(2)) 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. BioMed Central 2017-11-10 /pmc/articles/PMC5681801/ /pubmed/29126396 http://dx.doi.org/10.1186/s12885-017-3732-4 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Kiechle, Marion
Dukatz, Ricarda
Yahiaoui-Doktor, Maryam
Berling, Anika
Basrai, Maryam
Staiger, Vera
Niederberger, Uwe
Marter, Nicole
Lammert, Jacqueline
Grill, Sabine
Pfeifer, Katharina
Rhiem, Kerstin
Schmutzler, Rita K.
Laudes, Matthias
Siniatchkin, Michael
Halle, Martin
Bischoff, Stephan C.
Engel, Christoph
Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
title Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
title_full Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
title_fullStr Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
title_full_unstemmed Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
title_short Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)
title_sort feasibility of structured endurance training and mediterranean diet in brca1 and brca2 mutation carriers – an interventional randomized controlled multicenter trial (libre-1)
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681801/
https://www.ncbi.nlm.nih.gov/pubmed/29126396
http://dx.doi.org/10.1186/s12885-017-3732-4
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