This trial is active, not recruiting.

Condition hereditary breast and ovarian cancer
Treatment structured exercise training plus mediterranean diet
Sponsor Technische Universität München
Start date February 2014
End date November 2014
Trial size 69 participants
Trial identifier NCT02087592, LIBRE-F-110013


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(No Intervention)
Usual standard of care
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
structured exercise training plus mediterranean diet

Primary Outcomes

Number of patients successfully completing the intervention program
time frame: 3 months

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 69 years old.

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

Additional Information

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
Principal investigator Marion Kiechle, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Technische Universität München.