Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Technical University of Munich600 enrolled

Overview

The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

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 efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Hereditary Breast and Ovarian Cancer

Interventions

Structured exercise training plus mediterranean dietBEHAVIORAL

Structured exercise training plus mediterranean diet

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * proven pathogenic BRCA1/2 mutation * age \>=18 * written informed consent Exclusion Criteria: * current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible) * metastatic tumor disease * life expectancy \<3 years * clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg) * significant orthopedic disability which prevents from participating in the group interventions * severe concomitant diseases which prevents from participating in the group interventions * Karnofsky index \<60 * maximum 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

Locations (19)

Humboldt Universität zu Berlin

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire)

Adherence to mediterranean diet

Time frame: 12 months

body mass index (BMI)

Body weight (in kilograms) divided by body height (in meters) squared.

Time frame: 12 months

ventilatory threshold 1 (VT1) in spiroergometry

ventilatory threshold VT1 in spiroergometry

Time frame: 12 months

Secondary Outcomes

stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire

(TICS) questionnaire

Time frame: 3, 12, 24, 36 months

grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire

Life Orientation Test (LOT)

Time frame: 3, 12, 24, 36 months

attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire

(BKAE) questionnaire

Time frame: 3, 12, 24, 36 months

quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

(EORTC QLQ-C30)

Time frame: 3, 12, 24, 36 months

maximum oxygen consumption (VO2max), as measured by spiroergometry

spiroergometry

Central Contacts

Marion Kiechle, Prof. Dr.

CONTACT

+49 89 4140 2420 marion.kiechle@tum.de

Daniela Schemmer

CONTACT

+49 89 4140 2433 Daniela.Schemmer@mri.tum.de

Data from ClinicalTrials.gov

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