NCT02516540

Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hereditary Breast and Ovarian Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Structured exercise training plus mediterranean diet	Structured exercise training plus mediterranean diet

Timeline

• Start date: 2015-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2015-08-06
• Last updated: 2024-04-11

Locations

19 sites across 1 country: Germany