Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Conditions

Hereditary Breast and Ovarian Cancer

Keywords

hereditary breast and ovarian cancer (HBOC), BRCA1/2 mutation carriers, Mediterranean diet, Structured exercise training, prevention

Brief summary

BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter feasibility trial is that a structured life-style intervention program with exercise training and mediterranean diet is feasible and improves the nutritional and fitness status as well as the weight, the quality of life and stress reacting capacity.

Seethaler B, Neyrinck AM, Basrai M, Kiechle M, Delzenne NM, Bischoff SC.

2025-07-261 citations

10.1016/j.lfs.2025.123855

Omega-3 polyunsaturated fatty acids improve intestinal barrier integrity—albeit to a lesser degree than short-chain fatty acids: an exploratory analysis of the randomized controlled LIBRE trial

Benjamin Seethaler, Katja Lehnert, Maryam Yahiaoui‐Doktor, Maryam Basrai, Walter Vetter et al. (7 authors)

European Journal of Nutrition2023-06-1536 citations

10.1007/s00394-023-03172-2

Short-chain fatty acids are key mediators of the favorable effects of the Mediterranean diet on intestinal barrier integrity: data from the randomized controlled LIBRE trial.

Seethaler B, Nguyen NK, Basrai M, Kiechle M, Walter J, Delzenne NM, Bischoff SC.

2022-10-01114 citations

10.1093/ajcn/nqac175

Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1).

Berling-Ernst A, Yahiaoui-Doktor M, Kiechle M, Engel C, Lammert J, Grill S, Dukatz R, Rhiem K, Baumann FT, Bischoff SC, Erickson N, Schmidt T, Niederberger U, Siniatchkin M, Halle M.

2022-02-211 citations

10.1038/s41598-022-06913-1

Abstract P6-10-16: High circulating levels of adrenomedullin are associated with metabolic syndrome and low cardiorespiratory fitness in <i>BRCA1</i> and <i>BRCA2</i> mutation carriers

Jacqueline Lammert, Sabine Grill, Maryam Yahiaoui‐Doktor, Maryam Basrai, Joachim Struck et al. (8 authors)

Cancer Research2020-02-15

10.1158/1538-7445.sabcs19-p6-10-16

Fatty acid profiles in erythrocyte membranes following the Mediterranean diet - data from a multicenter lifestyle intervention study in women with hereditary breast cancer (LIBRE).

Seethaler B, Basrai M, Vetter W, Lehnert K, Engel C, Siniatchkin M, Halle M, Kiechle M, Bischoff SC.

2019-11-0212 citations

10.1016/j.clnu.2019.10.033

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

Kiechle M, Dukatz R, Yahiaoui-Doktor M, Berling A, Basrai M, Staiger V, Niederberger U, Marter N, Lammert J, Grill S, Pfeifer K, Rhiem K, Schmutzler RK, Laudes M, Siniatchkin M, Halle M, Bischoff SC, Engel C.

2017-11-1025 citations

10.1186/s12885-017-3732-4

Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire

Katrin Hebestreit, Maryam Yahiaoui‐Doktor, Christoph Engel, Walter Vetter, Michael Siniatchkin et al. (9 authors)

BMC Cancer2017-05-18139 citations

10.1186/s12885-017-3337-y

Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study).

Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff S, Dukatz R, Gerber WD, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Marter N, Enders U, Löffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M.

2016-12-1919 citations

10.1186/s40814-016-0114-7

Interventions

BEHAVIORALStructured exercise training plus mediterranean diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 69 Years

Healthy volunteers

No

Inclusion criteria

* women with proven pathogenic BRCA1/2 mutation

Exclusion criteria

* metastatic tumor disease * life expectancy \<3 years * clinically limiting cardiovascular or respiratory disease * significant orthopedic disability which prevents from participating in the exercise training * severe concomitant disease which prevents from participating in the group interventions * Karnofsky index \<60 * VO2max \>150% * Maximal exercise capacity \< 50 W * food allergies which prevent from mediterranean diet * vegan diet * body mass index \<15 kg/m2 * pregnancy * insufficient knowledge of German language * insufficient compliance * active participation in other interventional trials * no informed consent

Design outcomes

Primary

Measure	Time frame
Number of patients successfully completing the intervention program	3 months

Secondary

Measure	Time frame
Grade of optimism (LOT)	3 months
Body mass index as a marker of caloric balance	3 months
Total fat intake	3 months
maximum exercise capacity (VO2max) as a marker of physical fitness	3 months
Quality of life (SF-36)	3 months
Physical activity (IPAQ questionnaire)	3 months
Stress coping capacity (TICS)	3 months

Other

Measure	Time frame
Eating behaviour	3 months
Laboratory parameters	3 months
Aerobic exercise capacity during ergometry	3 months
Body composition (body impedance analysis)	3 months
Anthropometric parameters (waist and hip circumference, skinfold measurements)	3 months

Countries

Germany

Outcome results

None listed