Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Not Applicable

Completed

• Conditions: Hereditary Breast and Ovarian Cancer
• Interventions: Behavioral: Structured exercise training plus mediterranean diet

• Registration Number: NCT02087592
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2014-11
• Status Verified: 2024-04
• Study Completion: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Structured exercise training plus mediterranean diet	Usual standard of care plus structured physical exercise training plus mediterranean-style diet

Primary Outcome Measures

Name	Time	Method
Number of patients successfully completing the intervention program	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

University of Cologne; 🇩🇪 Cologne, Germany

Technische Universitaet Muenchen; 🇩🇪 Munich, Germany