AzTrials
AzTrials

Hereditary Breast and Ovarian CancerLIBRENCT02087592

Feasibility 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 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 69 years, 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
69 participants
Where
3 sitesGermany
Study dates
Feb 2014to Apr 2024
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 to 69 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • women with proven pathogenic BRCA1/2 mutation

Who cannot join

  • metastatic tumor disease
  • life expectancy <3 years
  • clinically limiting cardiovascular or respiratory disease
  • significant orthopedic disability which prevents from participating in the exercise training
  • severe concomitant disease which prevents from participating in the group interventions
  • Karnofsky index <60
Show all 16Show fewer
  • VO2max >150%
  • Maximal 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
  • no informed consent

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • University of Cologne

    Cologne

  • University of Schleswig-Holstein Campus Kiel

    Kiel

  • Technische Universitaet Muenchen

    Munich

Other trials in Germany

About this study

Official title: Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations

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.

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

Study groups in NCT02087592
Study groupRoleWhat they receive
ControlNo interventionUsual standard of care
InterventionExperimentalUsual standard of care plus structured physical exercise training plus mediterranean-style 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. Number of patients successfully completing the intervention program

    Measured: 3 months

Secondary outcomes (7)

  1. Stress coping capacity (TICS)

    Measured: 3 months

  2. Grade of optimism (LOT)

    Measured: 3 months

  3. Body mass index as a marker of caloric balance

    Measured: 3 months

  4. Total fat intake

    Measured: 3 months

  5. maximum exercise capacity (VO2max) as a marker of physical fitness

    Measured: 3 months

  6. Quality of life (SF-36)

    Measured: 3 months

  7. Physical activity (IPAQ questionnaire)

    Measured: 3 months

Timeline

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

  1. First posted14 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2014
  4. Study completionApr 2024

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
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02087592
Sponsor's protocol ID
LIBRE-F-110013
Acronym
LIBRE
Status last verified
Apr 2024
First submitted
12 Mar 2014
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40721110

  • 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.

    PubMed 37318580

  • 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

  • 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.

    PubMed 35190584

  • 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.

    PubMed 31735538

  • 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.

    PubMed 29126396

  • 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.

    PubMed 28521737

  • 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.

    PubMed 28031860

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 3 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 1 inclusion and 16 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: finished, as of the sponsor's last update on 16 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 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients successfully completing the intervention program (time frame: 3 months). 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 NCT02087592, which also lists 8 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 16 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in