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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02087592
First Posted: March 14, 2014
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
March 12, 2014
March 14, 2014
April 28, 2017
February 2014
November 2014   (Final data collection date for primary outcome measure)
Number of patients successfully completing the intervention program [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT02087592 on ClinicalTrials.gov Archive Site
  • Stress coping capacity (TICS) [ Time Frame: 3 months ]
  • Grade of optimism (LOT) [ Time Frame: 3 months ]
  • Body mass index as a marker of caloric balance [ Time Frame: 3 months ]
  • Total fat intake [ Time Frame: 3 months ]
  • maximum exercise capacity (VO2max) as a marker of physical fitness [ Time Frame: 3 months ]
  • Quality of life (SF-36) [ Time Frame: 3 months ]
  • Physical activity (IPAQ questionnaire) [ Time Frame: 3 months ]
Same as current
  • Anthropometric parameters (waist and hip circumference, skinfold measurements) [ Time Frame: 3 months ]
  • Body composition (body impedance analysis) [ Time Frame: 3 months ]
  • Eating behaviour [ Time Frame: 3 months ]
  • Laboratory parameters [ Time Frame: 3 months ]
  • Aerobic exercise capacity during ergometry [ Time Frame: 3 months ]
Same as current
 
Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hereditary Breast and Ovarian Cancer
Behavioral: Structured exercise training plus mediterranean diet
  • No Intervention: Control
    Usual standard of care
  • Experimental: Intervention
    Usual standard of care plus structured physical exercise training plus mediterranean-style diet
    Intervention: Behavioral: Structured exercise training plus mediterranean diet
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, Löffler 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
69
June 2017
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • women with proven pathogenic BRCA1/2 mutation

Exclusion Criteria:

  • 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
  • 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
Sexes Eligible for Study: Female
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02087592
LIBRE-F-110013
No
Not Provided
Not Provided
Technische Universität München
Technische Universität München
Not Provided
Principal Investigator: Marion Kiechle, Prof. Dr. Technische Universität München
Study Director: Martin Halle, Prof. Dr. Technische Universität München
Study Director: Stephan C Bischoff, Prof. Dr. Universitaet Hohenheim, Stuttgart
Study Director: Wolf-Dieter Gerber, Prof. Dr. Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Study Director: Markus Loeffler, Prof. Dr. University of Leipzig
Study Director: Christoph Engel, Dr. University of Leipzig
Study Director: Rita K Schmutzler, Prof. Dr. University of Cologne
Study Director: Alfons Meindl, Prof. Dr. Technische Universität München
Technische Universität München
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP