Clinical trial NCT02087592: Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Official title: Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer
Keywords: hereditary breast and ovarian cancer (HBOC)
BRCA1/2 mutation carriers
Mediterranean diet
Structured exercise training
prevention
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients successfully completing the intervention program
timeFrame: 3 months
Secondary outcomes:
measure: Stress coping capacity (TICS)
timeFrame: 3 months
measure: Grade of optimism (LOT)
timeFrame: 3 months
measure: Body mass index as a marker of caloric balance
timeFrame: 3 months
measure: Total fat intake
timeFrame: 3 months
measure: maximum exercise capacity (VO2max) as a marker of physical fitness
timeFrame: 3 months
measure: Quality of life (SF-36)
timeFrame: 3 months
measure: Physical activity (IPAQ questionnaire)
timeFrame: 3 months
Other outcomes:
measure: Anthropometric parameters (waist and hip circumference, skinfold measurements)
timeFrame: 3 months
measure: Body composition (body impedance analysis)
timeFrame: 3 months
measure: Eating behaviour
timeFrame: 3 months
measure: Laboratory parameters
timeFrame: 3 months
measure: Aerobic exercise capacity during ergometry
timeFrame: 3 months
Locations:
city: Cologne
country: Germany
facility: University of Cologne
city: Kiel
country: Germany
facility: University of Schleswig-Holstein Campus Kiel
city: Munich
country: Germany
facility: Technische Universitaet Muenchen
Study officials:
affiliation: Technical University of Munich
name: Marion Kiechle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Martin Halle, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitaet Hohenheim, Stuttgart
name: Stephan C Bischoff, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
name: Wolf-Dieter Gerber, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Leipzig
name: Markus Loeffler, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Leipzig
name: Christoph Engel, Dr.
role: STUDY_DIRECTOR
affiliation: University of Cologne
name: Rita K Schmutzler, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Technical University of Munich
name: Alfons Meindl, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Seethaler B, Nguyen NK, Basrai M, Kiechle M, Walter J, Delzenne NM, Bischoff SC. 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. Am J Clin Nutr. 2022 Oct 6;116(4):928-942. doi: 10.1093/ajcn/nqac175.
citation: 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. Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1). Sci Rep. 2022 Feb 21;12(1):2907. doi: 10.1038/s41598-022-06913-1.
citation: Seethaler B, Basrai M, Vetter W, Lehnert K, Engel C, Siniatchkin M, Halle M, Kiechle M, Bischoff SC. Fatty acid profiles in erythrocyte membranes following the Mediterranean diet - data from a multicenter lifestyle intervention study in women with hereditary breast cancer (LIBRE). Clin Nutr. 2020 Aug;39(8):2389-2398. doi: 10.1016/j.clnu.2019.10.033. Epub 2019 Nov 2.
citation: 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. Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers - an interventional randomized controlled multicenter trial (LIBRE-1). BMC Cancer. 2017 Nov 10;17(1):752. doi: 10.1186/s12885-017-3732-4.
citation: Hebestreit K, Yahiaoui-Doktor M, Engel C, Vetter W, Siniatchkin M, Erickson N, Halle M, Kiechle M, Bischoff SC. Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. BMC Cancer. 2017 May 18;17(1):341. doi: 10.1186/s12885-017-3337-y.
citation: 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, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study). Pilot Feasibility Stud. 2016 Dec 19;2:74. doi: 10.1186/s40814-016-0114-7. eCollection 2016.