Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-21 @ 1:33 AM
Study NCT ID:
NCT02087592
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061325', 'term': 'Hereditary Breast and Ovarian Cancer Syndrome'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-03-13', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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'}], 'primaryOutcomes': [{'measure': 'Number of patients successfully completing the intervention program', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hereditary breast and ovarian cancer (HBOC)', 'BRCA1/2 mutation carriers', 'Mediterranean diet', 'Structured exercise training', 'prevention'], 'conditions': ['Hereditary Breast and Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '40721110', 'type': 'DERIVED', 'citation': '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': '37318580', 'type': 'DERIVED', 'citation': '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': '36055959', 'type': 'DERIVED', '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.'}, {'pmid': '35190584', 'type': 'DERIVED', '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.'}, {'pmid': '31735538', 'type': 'DERIVED', '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.'}, {'pmid': '29126396', 'type': 'DERIVED', '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.'}, {'pmid': '28521737', 'type': 'DERIVED', '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.'}, {'pmid': '28031860', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.frauenklinik.med.tum.de/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with proven pathogenic BRCA1/2 mutation\n\nExclusion Criteria:\n\n* metastatic tumor disease\n* life expectancy \\<3 years\n* clinically limiting cardiovascular or respiratory disease\n* significant orthopedic disability which prevents from participating in the exercise training\n* severe concomitant disease which prevents from participating in the group interventions\n* Karnofsky index \\<60\n* VO2max \\>150%\n* Maximal exercise capacity \\< 50 W\n* food allergies which prevent from mediterranean diet\n* vegan diet\n* body mass index \\<15 kg/m2\n* pregnancy\n* insufficient knowledge of German language\n* insufficient compliance\n* active participation in other interventional trials\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT02087592', 'acronym': 'LIBRE', 'briefTitle': 'Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations', 'orgStudyIdInfo': {'id': 'LIBRE-F-110013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Usual standard of care plus structured physical exercise training plus mediterranean-style diet', 'interventionNames': ['Behavioral: Structured exercise training plus mediterranean diet']}], 'interventions': [{'name': 'Structured exercise training plus mediterranean diet', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'University of Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Technische Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Marion Kiechle, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}, {'name': 'Martin Halle, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University of Munich'}, {'name': 'Stephan C Bischoff, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaet Hohenheim, Stuttgart'}, {'name': 'Wolf-Dieter Gerber, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaetsklinikum Schleswig-Holstein, Campus Kiel'}, {'name': 'Markus Loeffler, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leipzig'}, {'name': 'Christoph Engel, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leipzig'}, {'name': 'Rita K Schmutzler, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Cologne'}, {'name': 'Alfons Meindl, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}