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
  Purpose

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.


Condition Intervention
Hereditary Breast and Ovarian Cancer
Behavioral: Structured exercise training plus mediterranean diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Number of patients successfully completing the intervention program [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual standard of care
Experimental: Intervention
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
Behavioral: Structured exercise training plus mediterranean diet

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087592

Contacts
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

Locations
Germany
University of Cologne Recruiting
Cologne, Germany
Principal Investigator: Rita K Schmutzler, Prof. Dr.         
University of Schleswig-Holstein Campus Kiel Recruiting
Kiel, Germany
Principal Investigator: Wolf-Dieter Gerber, Prof. Dr.         
Technische Universitaet Muenchen Recruiting
Munich, Germany
Principal Investigator: Marion Kiechle, Prof. Dr.         
Sponsors and Collaborators
Technische Universität München
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02087592     History of Changes
Other Study ID Numbers: LIBRE-F-110013
Study First Received: March 12, 2014
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Committee

Keywords provided by Technische Universität München:
hereditary breast and ovarian cancer (HBOC)
BRCA1/2 mutation carriers
Mediterranean diet
Structured exercise training
prevention

Additional relevant MeSH terms:
Ovarian Neoplasms
Hereditary Breast and Ovarian Cancer Syndrome
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014