Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Hereditary Breast and Ovarian Cancer Clinical Trial

— LIBRE-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02516540
• Other study ID #: LIBRE-2-20150626
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Technical University of Munich
• Contact: Marion Kiechle, Prof. Dr.
• Phone: +49 89 4140 2420
• Email: marion.kiechle[@]tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Neoplasms

Intervention

Behavioral:
• Structured exercise training plus mediterranean diet
Structured exercise training plus mediterranean diet

Locations

Country	Name	City	State
Germany	Humboldt Universität zu Berlin	Berlin
Germany	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Kliniken Essen-Mitte	Essen
Germany	Universitätsklinikum Essen	Essen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinium Heidelberg	Heidelberg
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Uniklinikum Köln	Köln
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Technische Universität München	München
Germany	Universität Regensburg	Regensburg
Germany	Interdisziplinäres Brustzentrum am Diakonieklinikum	Stuttgart
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universität Ulm	Ulm
Germany	Universitätsklinikum Würzburg	Würzburg

Sponsors (5)

Lead Sponsor	Collaborator
Technical University of Munich	University Hospital Schleswig-Holstein, University of Cologne, University of Hohenheim, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)	Adherence to mediterranean diet	12 months
Primary	body mass index (BMI)	Body weight (in kilograms) divided by body height (in meters) squared.	12 months
Primary	ventilatory threshold 1 (VT1) in spiroergometry	ventilatory threshold VT1 in spiroergometry	12 months
Secondary	stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire	(TICS) questionnaire	3, 12, 24, 36 months
Secondary	grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire	Life Orientation Test (LOT)	3, 12, 24, 36 months
Secondary	attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire	(BKAE) questionnaire	3, 12, 24, 36 months
Secondary	quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	(EORTC QLQ-C30)	3, 12, 24, 36 months
Secondary	maximum oxygen consumption (VO2max), as measured by spiroergometry	spiroergometry	3, 12 months
Secondary	physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)	Physical Activity	3, 12, 24, 36 months
Secondary	incidence of breast cancer	During study	12, 24, 36 months
Secondary	Mediterranean Diet Adherence Screener (MEDAS) Score	(MEDAS) Score	3, 6, 9, 12, 24, 36 months
Secondary	body mass index (BMI)	(BMI)	3, 12, 24, 36 months
Secondary	change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry	spiroergometry	3, 12 months
Secondary	mortality rate	During study	12, 24, 36 months
Secondary	satisfaction (questionnaire)	satisfaction (questionnaire)	3, 12, 24, 36 months
Secondary	tobacco consumption	survey	12, 24, 36 months
Secondary	alcohol consumption	survey	12, 24, 36 months
Secondary	dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ)	(EPIC-FFQ)	3, 12, 24, 36 months
Secondary	serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin	Blood Test	3, 12, 24, 36 months
Secondary	proenkephalin	Genetic test	3, 12, 24, 36 months
Secondary	Omega 3 fatty acid in the erythrocyte Membrane, Omega 6 fatty acid level in the erythrocyte Membraserum low density, lipoprotein cholesterolne, Omega 9 fatty acid level in the erythrocyte Membrane,	Blood Test	3, 12, 24, 36 months