Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

NCT02087592 | Completed

• 1 other identifier: LIBRE-F-110013
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

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.

Conditions

Hereditary Breast and Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of patients successfully completing the intervention program

  3 months

Secondary Outcomes (7)

• 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

Other Outcomes (5)

• Anthropometric parameters (waist and hip circumference, skinfold measurements)

  3 months

• Body composition (body impedance analysis)

  3 months

• Eating behaviour

  3 months

Study Arms (2)

Control

NO INTERVENTION

Usual standard of care

Intervention

EXPERIMENTAL

Usual standard of care plus structured physical exercise training plus mediterranean-style diet

Behavioral: Structured exercise training plus mediterranean diet

Interventions

Structured exercise training plus mediterranean diet BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with proven pathogenic BRCA1/2 mutation

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (3)

University of Cologne

Cologne, Germany

Location

University of Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Technische Universitaet Muenchen

Munich, Germany

Location

Related Publications (8)

• Seethaler B, Neyrinck AM, Basrai M, Kiechle M, Delzenne NM, Bischoff SC. Elucidating the effect of the Mediterranean diet on fecal bile acids and their mediating role on biomarkers of intestinal barrier function: An exploratory analysis of a randomized controlled trial. Life Sci. 2025 Oct 15;379:123855. doi: 10.1016/j.lfs.2025.123855. Epub 2025 Jul 26.

  PMID: 40721110 DERIVED

• Seethaler B, Lehnert K, Yahiaoui-Doktor M, Basrai M, Vetter W, Kiechle M, Bischoff SC. 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. Eur J Nutr. 2023 Oct;62(7):2779-2791. doi: 10.1007/s00394-023-03172-2. Epub 2023 Jun 15.

  PMID: 37318580 DERIVED

• 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.

  PMID: 36055959 DERIVED

• 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.

  PMID: 35190584 DERIVED

• 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.

  PMID: 31735538 DERIVED

• 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.

  PMID: 29126396 DERIVED

• 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.

  PMID: 28521737 DERIVED

• 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.

  PMID: 28031860 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marion Kiechle, Prof. Dr.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Martin Halle, Prof. Dr.

  Technical University of Munich

  STUDY DIRECTOR

• Stephan C Bischoff, Prof. Dr.

  Universitaet Hohenheim, Stuttgart

  STUDY DIRECTOR

• Wolf-Dieter Gerber, Prof. Dr.

  Universitaetsklinikum Schleswig-Holstein, Campus Kiel

  STUDY DIRECTOR

• Markus Loeffler, Prof. Dr.

  University of Leipzig

  STUDY DIRECTOR

• Christoph Engel, Dr.

  University of Leipzig

  STUDY DIRECTOR

• Rita K Schmutzler, Prof. Dr.

  University of Cologne

  STUDY DIRECTOR

• Alfons Meindl, Prof. Dr.

  Technical University of Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

DE (3)