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

Technical University of Munich

Status

Completed

Conditions

Hereditary Breast and Ovarian Cancer

Treatments

Behavioral: Structured exercise training plus mediterranean diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02087592

LIBRE-F-110013

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

Female

Ages

18 to 69 years old

Volunteers

No 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