Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

NCT02516540 | Recruiting

• 1 other identifier: LIBRE-2-20150626
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 19

Brief Summary

The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

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 (3)

• Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)

  Adherence to mediterranean diet

  12 months

• body mass index (BMI)

  Body weight (in kilograms) divided by body height (in meters) squared.

  12 months

• ventilatory threshold 1 (VT1) in spiroergometry

  ventilatory threshold VT1 in spiroergometry

  12 months

Secondary Outcomes (18)

• stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire

  3, 12, 24, 36 months

• grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire

  3, 12, 24, 36 months

• attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire

  3, 12, 24, 36 months

• quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  3, 12, 24, 36 months

• maximum oxygen consumption (VO2max), as measured by spiroergometry

  3, 12 months

Study Arms (2)

Control

NO INTERVENTION

Study participants are instructed regarding a healthy diet according to the recommendations of the German Nutrition Society (DGE) and are informed about positive effects of physical activity on incidence and prognosis of breast cancer

Intervention

EXPERIMENTAL

Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet.

Behavioral: Structured exercise training plus mediterranean diet

Interventions

Structured exercise training plus mediterranean diet BEHAVIORAL

Structured exercise training plus mediterranean diet

Intervention

Eligibility Criteria

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

You may qualify if:

• proven pathogenic BRCA1/2 mutation
• age \>=18
• written informed consent

You may not qualify if:

• metastatic tumor disease
• life expectancy \<3 years
• clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
• significant orthopedic disability which prevents from participating in the group interventions
• severe concomitant diseases which prevents from participating in the group interventions
• Karnofsky index \<60
• maximum 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
• University of Hohenheim: collaborator
• University Hospital Schleswig-Holstein: collaborator
• University of Leipzig: collaborator
• University of Cologne: collaborator

Study Sites (19)

Humboldt Universität zu Berlin

Berlin, Germany

RECRUITING

Uniklinikum Köln

Cologne, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

RECRUITING

Kliniken Essen-Mitte

Essen, Germany

RECRUITING

Universitätsklinikum Essen

Essen, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Universitätsklinium Heidelberg

Heidelberg, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Germany

NOT YET RECRUITING

Technische Universität München

München, Germany

RECRUITING

Universität Regensburg

Regensburg, Germany

RECRUITING

Interdisziplinäres Brustzentrum am Diakonieklinikum

Stuttgart, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Germany

RECRUITING

Universität Ulm

Ulm, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Germany

RECRUITING

Related Publications (2)

• 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

• Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff SC, Dukatz R, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Enders U, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:368. doi: 10.1186/s13063-016-1504-0.

  PMID: 27473440 DERIVED

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

  STUDY DIRECTOR

• Martin Halle, Prof. Dr.

  Technical University of Munich

  STUDY DIRECTOR

• Stephan C Bischoff, Prof. Dr.

  Universitaet Hohenheim, Stuttgart

  STUDY DIRECTOR

• Michael Siniatchkin, Prof. Dr.

  University Hospital Schleswig-Holstein

  STUDY DIRECTOR

• Markus Loeffler, Prof. Dr.

  University of Leipzig

  STUDY DIRECTOR

• Christoph Engel, PD 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

• Anne S Quante, Dr.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Kiechle, Prof. Dr.

CONTACT

+49 89 4140 2420; marion.kiechle@tum.de

Daniela Schemmer

CONTACT

+49 89 4140 2433; Daniela.Schemmer@mri.tum.de

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: July 22, 2015
• First Posted: August 6, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

DE (19)