Clinical Trial: Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations
Brief 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.
Detailed Summary:
Sponsor: Technische Universität München
Current Primary Outcome: Number of patients successfully completing the intervention program [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Stress coping capacity (TICS) [ Time Frame: 3 months ]
- Grade of optimism (LOT) [ Time Frame: 3 months ]
- Body mass index as a marker of caloric balance [ Time Frame: 3 months ]
- Total fat intake [ Time Frame: 3 months ]
- maximum exercise capacity (VO2max) as a marker of physical fitness [ Time Frame: 3 months ]
- Quality of life (SF-36) [ Time Frame: 3 months ]
- Physical activity (IPAQ questionnaire) [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Technische Universität München
Dates:
Date Received: March 12, 2014
Date Started: February 2014
Date Completion: June 2017
Last Updated: April 27, 2017
Last Verified: April 2017
