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

April 10, 2024 updated by: Technical University of Munich

Prospective Randomized Multicenter Trial to Assess the Efficacy of a Structured Physical Exercise Training and Mediterranean Diet in Women With BRCA1/2 Mutations

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany
        • Recruiting
        • Humboldt Universität zu Berlin
      • Dresden, Germany
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
      • Düsseldorf, Germany
        • Recruiting
        • Universitätsklinikum Düsseldorf
      • Essen, Germany
        • Recruiting
        • Kliniken Essen-Mitte
      • Essen, Germany
        • Recruiting
        • Universitatsklinikum Essen
      • Freiburg, Germany
        • Recruiting
        • Universitätsklinikum Freiburg
      • Göttingen, Germany
        • Recruiting
        • Universitätsmedizin Göttingen
      • Hamburg, Germany
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Recruiting
        • Universitätsklinium Heidelberg
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Köln, Germany
        • Recruiting
        • Uniklinikum Köln
      • Leipzig, Germany
        • Not yet recruiting
        • Universitätsklinikum Leipzig
      • München, Germany
        • Recruiting
        • Technische Universität München
      • Regensburg, Germany
        • Recruiting
        • Universitat Regensburg
      • Stuttgart, Germany
        • Recruiting
        • Interdisziplinäres Brustzentrum am Diakonieklinikum
      • Tübingen, Germany
        • Recruiting
        • Universitätsklinikum Tübingen
      • Ulm, Germany
        • Recruiting
        • Universität Ulm
      • Würzburg, Germany
        • Recruiting
        • Universitätsklinikum Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)
Time Frame: 12 months
Adherence to mediterranean diet
12 months
body mass index (BMI)
Time Frame: 12 months
Body weight (in kilograms) divided by body height (in meters) squared.
12 months
ventilatory threshold 1 (VT1) in spiroergometry
Time Frame: 12 months
ventilatory threshold VT1 in spiroergometry
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire
Time Frame: 3, 12, 24, 36 months
(TICS) questionnaire
3, 12, 24, 36 months
grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire
Time Frame: 3, 12, 24, 36 months
Life Orientation Test (LOT)
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
Time Frame: 3, 12, 24, 36 months
(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)
Time Frame: 3, 12, 24, 36 months
(EORTC QLQ-C30)
3, 12, 24, 36 months
maximum oxygen consumption (VO2max), as measured by spiroergometry
Time Frame: 3, 12 months
spiroergometry
3, 12 months
physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame: 3, 12, 24, 36 months
Physical Activity
3, 12, 24, 36 months
incidence of breast cancer
Time Frame: 12, 24, 36 months
During study
12, 24, 36 months
Mediterranean Diet Adherence Screener (MEDAS) Score
Time Frame: 3, 6, 9, 12, 24, 36 months
(MEDAS) Score
3, 6, 9, 12, 24, 36 months
body mass index (BMI)
Time Frame: 3, 12, 24, 36 months
(BMI)
3, 12, 24, 36 months
change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry
Time Frame: 3, 12 months
spiroergometry
3, 12 months
mortality rate
Time Frame: 12, 24, 36 months
During study
12, 24, 36 months
satisfaction (questionnaire)
Time Frame: 3, 12, 24, 36 months
satisfaction (questionnaire)
3, 12, 24, 36 months
tobacco consumption
Time Frame: 12, 24, 36 months
survey
12, 24, 36 months
alcohol consumption
Time Frame: 12, 24, 36 months
survey
12, 24, 36 months
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
(EPIC-FFQ)
3, 12, 24, 36 months
serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin
Time Frame: 3, 12, 24, 36 months
Blood Test
3, 12, 24, 36 months
proenkephalin
Time Frame: 3, 12, 24, 36 months
Genetic test
3, 12, 24, 36 months
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,
Time Frame: 3, 12, 24, 36 months
Blood Test
3, 12, 24, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Cologne
University of Leipzig
University Hospital Schleswig-Holstein
University of Hohenheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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., 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., Technical University of Munich
  • Principal Investigator: Anne S Quante, Dr., Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIBRE-2-20150626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings