Evidence map›Paper›PMID 28031860›Full record

ArticlePilot and feasibility studies2016

Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study).

Marion Kiechle, Christoph Engel, Anika Berling, Katrin Hebestreit, Stephan Bischoff, Ricarda Dukatz, Wolf-Dieter Gerber, Michael Siniatchkin, Katharina Pfeifer, Sabine Grill and 11 more

Registry-linked trialOpen access · goldAbstract read

PubMed Full text at PMC Publisher

In one paragraph

Article in Pilot and feasibility studies, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02087592 (Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations), which is not on this map. Cited by 14 papers.

0numbers the graph read from it

0cells of the map it votes in

14citing papers in PubMed

2.4field-weighted citation impact, top 10% of its field

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02087592 nacompletednot on this map

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

TypeinterventionalSponsorTechnical University of MunichRan2014 to 2024Enrolled69ConditionsHereditary Breast and Ovarian CancerArmsStructured exercise training plus mediterranean diet

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 34 citations in OpenAlex.

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.European journal of nutrition · 2023
Trial
How Does Dietary Intake Relate to Dispositional Optimism and Health-Related Quality of Life in GermlineNutrients · 2023
Trial
Feasibility study to assess the impact of a lifestyle intervention ('LivingWELL') in people having an assessment of their family history of colorectal or breast cancer.BMJ open · 2018
Trial
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
Trial
Mechanistic understanding of female reproductive aging based on the chicken model.Journal of animal science and biotechnology · 2026
Review
Associations of height, body mass index, and weight gain with breast cancer risk in carriers of a pathogenic variant in BRCA1 or BRCA2: the BRCA1 and BRCA2 Cohort Consortium.Breast cancer research : BCR · 2023
Article
The Role of the Surgeon in the Germline Testing of the Newly Diagnosed Breast Cancer Patient.Current oncology (Toronto, Ont.) · 2023
Review
Associations of Plasma Bioactive Adrenomedullin Levels with Cardiovascular Risk Factors inGeburtshilfe und Frauenheilkunde · 2022
Article
Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1).Scientific reports · 2022
Article
Management Strategies of Breast Cancer Patients withOncoTargets and therapy · 2022
Review
Physical activity and Mediterranean diet as potential modulators of osteoprotegerin and soluble RANKL in gBRCA1/2 mutation carriers: results of the lifestyle intervention pilot study LIBRE-1.Breast cancer research and treatment · 2021
Article
Investigating Contributions of Physical Inactivity and Obesity to Racial Disparities in Cancer Risk and Mortality Warrants More Consideration.Journal of the National Cancer Institute · 2021
Article
Precursor fractions of neurotensin and enkephalin might point to molecular mechanisms of cancer risk modulation during a lifestyle-intervention in germline BRCA1/2 gene mutation carriers.Breast cancer research and treatment · 2021
Article
Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire.BMC cancer · 2017
Article

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 1 country.

Marion KiechleDepartment of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.ORCID 0000-0003-4237-2657

Christoph EngelInstitute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Haertelstrasse 16-18, 04107 Leipzig, Germany.

Anika BerlingDepartment of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany ; Else Kroener-Fresenius Prevention Center, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

Katrin HebestreitInstitute for Nutritional Medicine, University Hohenheim, Fruwirthstr. 12, 70593 Stuttgart, Germany.

Stephan BischoffInstitute for Nutritional Medicine, University Hohenheim, Fruwirthstr. 12, 70593 Stuttgart, Germany.

Ricarda DukatzDepartment of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

Wolf-Dieter GerberInstitute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein, Campus Kiel, Preusserstr. 1-9, 24105 Kiel, Germany.

Michael SiniatchkinInstitute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein, Campus Kiel, Preusserstr. 1-9, 24105 Kiel, Germany.

Katharina PfeiferDepartment of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

Sabine GrillDepartment of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

Maryam Yahiaoui-DoktorInstitute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Haertelstrasse 16-18, 04107 Leipzig, Germany.

Ellen KirschInstitute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein, Campus Kiel, Preusserstr. 1-9, 24105 Kiel, Germany.

Uwe NiederbergerInstitute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein, Campus Kiel, Preusserstr. 1-9, 24105 Kiel, Germany.

Nicole MarterInstitute for Medical Psychology and Sociology, University Hospital Schleswig-Holstein, Campus Kiel, Preusserstr. 1-9, 24105 Kiel, Germany.

Ute EndersInstitute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Haertelstrasse 16-18, 04107 Leipzig, Germany.

Markus LöfflerInstitute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Haertelstrasse 16-18, 04107 Leipzig, Germany.

Alfons MeindlDepartment of Gynecology and Center for Hereditary Breast and Ovarian Cancer, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

Kerstin RhiemCenter for Hereditary Breast and Ovarian Cancer, University Hospital Cologne, Kerpener Str. 34, 50931 Cologne, Germany.

Rita SchmutzlerCenter for Hereditary Breast and Ovarian Cancer, University Hospital Cologne, Kerpener Str. 34, 50931 Cologne, Germany.

Nicole EricksonDepartment of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany ; Else Kroener-Fresenius Prevention Center, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

Martin HalleDepartment of Prevention and Sports Medicine, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany ; Else Kroener-Fresenius Prevention Center, Klinikum rechts der Isar, Technical University Munich (TUM), Ismaninger Str. 22, 81675 Munich, Germany.

TUM Klinikum · DEUniversity Hospital Schleswig-Holstein · DELeipzig University · DEUniversity Hospital Cologne · DEUniversity of Hohenheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWomen with highly penetrant BRCA mutations have a 55-60% lifetime risk for breast cancer and a 16-59% lifetime risk for ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. These include lifestyle factors such as physical activity status, dietary habits, and body weight. The modification of penetrance by changing lifestyle factors has not thus far been investigated in a randomized trial in BRCA mutation carriers.

methodsTherefore, we intend to enroll 60 BRCA1/2 mutation carriers in a pilot feasibility study (Lifestyle Intervention Study in Women with Hereditary Breast and Ovarian Cancer (LIBRE) pilot). This multi-center, prospective, controlled trial aims to randomize (1:1) participants into a (1) multi-factorial lifestyle intervention group (IG) versus (2) the control group with usual care (CG). The primary endpoint is feasibility and acceptance of a structured interdisciplinary lifestyle intervention program over 12 months (at least 70% of the patients to complete the 1-year intervention). Furthermore, the effects on physical fitness, BMI, quality of life, and stress coping capacity will be investigated. During the first 3 months, women in the IG will receive structured, individualized and mainly supervised endurance training of ≥18 MET*h/week (MET = metabolic equivalent task) and personal nutritional counseling based on the Mediterranean diet. During the subsequent 9 months, the IG will receive monthly group training sessions and regular telephone contacts for motivation, whereas the CG will only receive usual care (one general counseling on healthy nutrition and benefits of regular physical activity on health status). At randomization and subsequent time points (3, 6, 12 months), cardiopulmonary fitness will be assessed by spiroergometry and nutritional and psychological status by validated questionnaires. DISCUSSION: This pilot study will investigate the optimal strategy to improve physical fitness, nutritional habits, and psychological factors in women at high risk for developing breast or ovarian cancer. The results of this pilot feasibility study will be the basis for a larger prospective randomized trial including clinical events (LIBRE).

trial registrationClinicalTrials.gov, NCT02087592.

Indexed as

BRCA1BRCA2Hereditary breast cancerHereditary ovarian cancerLifestyle intervention

Identifiers

PMID28031860

DOI10.1186/s40814-016-0114-7

PMCPMC5165708

OpenAlexW2560471439

What OpenQuestion holds

Textmetadata

LicenceCC BY

Read underepoch 390

Registered trials

NCT02087592ClinicalTrials.gov

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.