Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE)

Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hereditary Breast and Ovarian Cancer
• Intervention / Treatment: Behavioral: Structured exercise training plus mediterranean diet

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • University of Cologne
  • Kiel, Germany
    • University of Schleswig-Holstein Campus Kiel
  • Munich, Germany
    • Technische Universitaet Muenchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual standard of care
Experimental: Intervention; Usual standard of care plus structured physical exercise training plus mediterranean-style diet	Behavioral: Structured exercise training plus mediterranean diet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life (SF-36)	3 months
Stress coping capacity (TICS)	3 months
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
Physical activity (IPAQ questionnaire)	3 months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Study Director: Martin Halle, Prof. Dr., Technical University of Munich; Study Director: Stephan C Bischoff, Prof. Dr., Universitaet Hohenheim, Stuttgart; Study Director: Markus Loeffler, Prof. Dr., University of Leipzig; Study Director: Rita K Schmutzler, Prof. Dr., University of Cologne; Study Director: Alfons Meindl, Prof. Dr., Technical University of Munich; Principal Investigator: Marion Kiechle, Prof. Dr., Technical University of Munich; Study Director: Wolf-Dieter Gerber, Prof. Dr., Universitaetsklinikum Schleswig-Holstein, Campus Kiel; Study Director: Christoph Engel, Dr., University of Leipzig

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimated): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: prevention; Mediterranean diet; hereditary breast and ovarian cancer (HBOC); BRCA1/2 mutation carriers; Structured exercise training
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Breast Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome
• Other Study ID Numbers: LIBRE-F-110013