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

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ClinicalTrials.gov Identifier: NCT02516540
Recruitment Status : Recruiting
First Posted : August 6, 2015
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
University of Hohenheim
University of Schleswig-Holstein
University of Leipzig
University of Cologne
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Behavioral: Structured exercise training plus mediterranean diet Not Applicable

Detailed Description:
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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Randomized Multicenter Trial to Assess the Efficacy of a Structured Physical Exercise Training and Mediterranean Diet in Women With BRCA1/2 Mutations
Actual Study Start Date : March 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
No Intervention: Control
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
Experimental: Intervention
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
Structured exercise training plus mediterranean diet




Primary Outcome Measures :
  1. Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire) [ Time Frame: 12 months ]
    Adherence to mediterranean diet

  2. body mass index (BMI) [ Time Frame: 12 months ]
  3. ventilatory threshold 1 (VT1) in spiroergometry [ Time Frame: 12 months ]
    ventilatory threshold VT1 in spiroergometry


Secondary Outcome Measures :
  1. stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire [ Time Frame: 3, 12, 24, 36 months ]
  2. grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire [ Time Frame: 3, 12, 24, 36 months ]
  3. attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire [ Time Frame: 3, 12, 24, 36 months ]
  4. quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: 3, 12, 24, 36 months ]
  5. maximum oxygen consumption (VO2max), as measured by spiroergometry [ Time Frame: 3, 12 months ]
  6. physical activity, as measured by the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 3, 12, 24, 36 months ]
  7. incidence of breast cancer [ Time Frame: 12, 24, 36 months ]
  8. Mediterranean Diet Adherence Screener (MEDAS) Score [ Time Frame: 3, 6, 9, 12, 24, 36 months ]
  9. body mass index (BMI) [ Time Frame: 3, 12, 24, 36 months ]
  10. change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry [ Time Frame: 3, 12 months ]
  11. mortality rate [ Time Frame: 12, 24, 36 months ]
  12. satisfaction (questionnaire) [ Time Frame: 3, 12, 24, 36 months ]
  13. tobacco consumption [ Time Frame: 12, 24, 36 months ]
  14. alcohol consumption [ Time Frame: 12, 24, 36 months ]
  15. dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ) [ Time Frame: 3, 12, 24, 36 months ]
  16. Omega 3 fatty acid in the erythrocyte membrane [ Time Frame: 3, 12, 24, 36 months ]
  17. Omega 6 fatty acid level in the erythrocyte membrane [ Time Frame: 3, 12, 24, 36 months ]
  18. Omega 9 fatty acid level in the erythrocyte membrane [ Time Frame: 3, 12, 24, 36 months ]
  19. serum cholesterol [ Time Frame: 3, 12, 24, 36 months ]
  20. serum high density lipoprotein cholesterol [ Time Frame: 3, 12, 24, 36 months ]
  21. serum low density lipoprotein cholesterol [ Time Frame: 3, 12, 24, 36 months ]
  22. serum triglycerides [ Time Frame: 3, 12, 24, 36 months ]
  23. serum glucose [ Time Frame: 3, 12, 24, 36 months ]
  24. c-reactive protein [ Time Frame: 3, 12, 24, 36 months ]
  25. serum insulin [ Time Frame: 3, 12, 24, 36 months ]
  26. body fat content, as measured by skin folds measurement [ Time Frame: 3, 12, 24, 36 months ]
  27. proenkephalin [ Time Frame: 3, 12, 24, 36 months ]
  28. proneurotensin [ Time Frame: 3, 12, 24, 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516540


Contacts
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Contact: Marion Kiechle, Prof. Dr. +49 89 4140 2420 marion.kiechle@tum.de
Contact: Daniela Schemmer +49 89 4140 2433 Daniela.Schemmer@mri.tum.de

Locations
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Germany
Humboldt Universität zu Berlin Recruiting
Berlin, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Recruiting
Dresden, Germany
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Kliniken Essen-Mitte Recruiting
Essen, Germany
Universitätsklinikum Essen Recruiting
Essen, Germany
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Universitätsklinium Heidelberg Recruiting
Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany
Uniklinikum Köln Recruiting
Köln, Germany
Universitätsklinikum Leipzig Not yet recruiting
Leipzig, Germany
Technische Universität München Recruiting
München, Germany
Universität Regensburg Recruiting
Regensburg, Germany
Interdisziplinäres Brustzentrum am Diakonieklinikum Recruiting
Stuttgart, Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany
Universität Ulm Recruiting
Ulm, Germany
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany
Sponsors and Collaborators
Technische Universität München
University of Hohenheim
University of Schleswig-Holstein
University of Leipzig
University of Cologne
Investigators
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Study Director: Marion Kiechle, Prof. Dr. Technische Universität München
Study Director: Martin Halle, Prof. Dr. Technische Universität München
Study Director: Stephan C Bischoff, Prof. Dr. Universitaet Hohenheim, Stuttgart
Study Director: Michael Siniatchkin, Prof. Dr. Universitätsklinikum Schleswig-Holstein, Campus Kiel
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. Technische Universität München
Principal Investigator: Anne S Quante, Dr. Technische Universität München

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02516540     History of Changes
Other Study ID Numbers: LIBRE-2-20150626
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by Technische Universität München:
hereditary breast and ovarian cancer (HBOC)
BRCA1/2 mutation carriers
Mediterranean diet
Structured exercise training
prevention

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hereditary Breast and Ovarian Cancer Syndrome
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases