LIBRE: Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Sponsor

Technische Universität München (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02087592

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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 or Disease	Intervention/Treatment	Phase
Hereditary Breast and Ovarian Cancer	Behavioral: Structured exercise training plus mediterranean diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Number of patients successfully completing the intervention program [3 months]

Secondary Outcome Measures

Stress coping capacity (TICS) [3 months]
Grade of optimism (LOT) [3 months]
Body mass index as a marker of caloric balance [3 months]
Total fat intake [3 months]
maximum exercise capacity (VO2max) as a marker of physical fitness [3 months]
Quality of life (SF-36) [3 months]
Physical activity (IPAQ questionnaire) [3 months]

Other Outcome Measures

Anthropometric parameters (waist and hip circumference, skinfold measurements) [3 months]
Body composition (body impedance analysis) [3 months]
Eating behaviour [3 months]
Laboratory parameters [3 months]
Aerobic exercise capacity during ergometry [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	University of Cologne	Cologne	Germany
2	University of Schleswig-Holstein Campus Kiel	Kiel	Germany
3	Technische Universitaet Muenchen	Munich	Germany

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