CompletedNot Applicable

Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Germany69 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range18 Years – 69 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of patients successfully completing the intervention program

Timeframe: 3 months

Trial details

NCT IDNCT02087592

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11