Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2Mutations

Not Applicable

Recruiting

• Conditions: C50; C56; Malignant neoplasm of breast; Malignant neoplasm of ovary

• Registration Number: DRKS00005736
• Lead Sponsor: Klinikum rechts der Isar der TU München, Frauenklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

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: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients successfully completing the intervention program<br>

Secondary Outcome Measures

Name	Time	Method
Stress coping capacity (TICS), Grade of optimism (LOT), Body Mass Index (BMI) as a marker for caloric balance, Total fat intake, Maximal Exercise Capacity (maximal oxygen consumption, VO2max) as a marker for physical fitness, physical activity (IPAQ), Quality of life (SF-36), all evaluated after 3, 12, 24, 36 months compared with baseline<br>