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Hereditary Breast and Ovarian CancerLIBRE-2NCT02516540

Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

A study testing Structured exercise training plus mediterranean diet in people with Hereditary Breast and Ovarian Cancer, run by Technical University of Munich at 19 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Hereditary Breast and Ovarian Cancer
What is being tested?
Structured exercise training plus mediterranean diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
19 sitesGermany
Study dates
Mar 2015to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

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

19 sites in 1 country

Germany19 sites, 19 recruiting

  • Humboldt Universität zu Berlin

    Berlin

    Recruiting

  • Uniklinikum Köln

    Cologne

    Recruiting

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf

    Recruiting

  • Kliniken Essen-Mitte

    Essen

    Recruiting

  • Universitätsklinikum Essen

    Essen

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

    Recruiting

  • Universitätsmedizin Göttingen

    Göttingen

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover

    Recruiting

  • Universitätsklinium Heidelberg

    Heidelberg

    Recruiting

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig

    Not yet recruiting

  • Technische Universität München

    München

    Recruiting

  • Universität Regensburg

    Regensburg

    Recruiting

  • Interdisziplinäres Brustzentrum am Diakonieklinikum

    Stuttgart

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen

    Recruiting

  • Universität Ulm

    Ulm

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Structured exercise training plus mediterranean diet
Keywords
hereditary breast and ovarian cancer (HBOC), BRCA1/2 mutation carriers, Mediterranean diet, Structured exercise training, prevention
Medical subject headings
Hereditary Breast and Ovarian Cancer Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured exercise training plus mediterranean dietBehavioural

    Structured exercise training plus mediterranean diet

Study groups in NCT02516540
Study groupRoleWhat they receive
ControlNo interventionStudy 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
InterventionExperimentalStructured 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.
Receives: Behavioral: Structured exercise training plus mediterranean diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)

    Adherence to mediterranean diet

    Measured: 12 months

  2. body mass index (BMI)

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

    Measured: 12 months

  3. ventilatory threshold 1 (VT1) in spiroergometry

    ventilatory threshold VT1 in spiroergometry

    Measured: 12 months

Secondary outcomes (18)

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

    (TICS) questionnaire

    Measured: 3, 12, 24, 36 months

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

    Life Orientation Test (LOT)

    Measured: 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

    (BKAE) questionnaire

    Measured: 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)

    (EORTC QLQ-C30)

    Measured: 3, 12, 24, 36 months

  5. maximum oxygen consumption (VO2max), as measured by spiroergometry

    spiroergometry

    Measured: 3, 12 months

  6. physical activity, as measured by the International Physical Activity Questionnaire (IPAQ)

    Physical Activity

    Measured: 3, 12, 24, 36 months

  7. incidence of breast cancer

    During study

    Measured: 12, 24, 36 months

  8. Mediterranean Diet Adherence Screener (MEDAS) Score

    (MEDAS) Score

    Measured: 3, 6, 9, 12, 24, 36 months

  9. body mass index (BMI)

    (BMI)

    Measured: 3, 12, 24, 36 months

  10. change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry

    spiroergometry

    Measured: 3, 12 months

  11. mortality rate

    During study

    Measured: 12, 24, 36 months

  12. satisfaction (questionnaire)

    satisfaction (questionnaire)

    Measured: 3, 12, 24, 36 months

  13. tobacco consumption

    survey

    Measured: 12, 24, 36 months

  14. alcohol consumption

    survey

    Measured: 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)

    (EPIC-FFQ)

    Measured: 3, 12, 24, 36 months

  16. serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin

    Blood Test

    Measured: 3, 12, 24, 36 months

  17. proenkephalin

    Genetic test

    Measured: 3, 12, 24, 36 months

  18. 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

    Measured: 3, 12, 24, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02516540
Sponsor's protocol ID
LIBRE-2-20150626
Acronym
LIBRE-2
Status last verified
Apr 2024
First submitted
22 Jul 2015
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36055959

  • 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.

    PubMed 27473440

Questions about this trial

What is this clinical trial studying?

A study testing Structured exercise training plus mediterranean diet in people with Hereditary Breast and Ovarian Cancer, run by Technical University of Munich at 19 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marion Kiechle, Prof. Dr. (+49 89 4140 2420, marion.kiechle@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02516540, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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