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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT02087592
First received: March 12, 2014
Last updated: August 5, 2014
Last verified: August 2014

March 12, 2014
August 5, 2014
February 2014
March 2015   (final data collection date for primary outcome measure)
Number of patients successfully completing the intervention program [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02087592 on ClinicalTrials.gov Archive Site
  • Stress coping capacity (TICS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Grade of optimism (LOT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body mass index as a marker of caloric balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Total fat intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • maximum exercise capacity (VO2max) as a marker of physical fitness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Physical activity (IPAQ questionnaire) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
  • Anthropometric parameters (waist and hip circumference, skinfold measurements) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body composition (body impedance analysis) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Eating behaviour [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Laboratory parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Aerobic exercise capacity during ergometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2015
March 2015   (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
Female
18 Years to 69 Years
No
Contact: Marion Kiechle, Prof. Dr. +49 89 4140 2420 marion.kiechle@lrz.tu-muenchen.de
Contact: Sabine Brandhorst +49 89 4140 2433 Sabine.Brandhorst@mri.tum.de
Germany
 
NCT02087592
LIBRE-F-110013
No
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
August 2014

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