NCT02087592Completed
Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations
Source: ClinicalTrials.gov · Last updated 16 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 12 Mar 2014
- Start date
- Feb 2014
- Primary completion date
- Nov 2014
- Lead sponsor
- Technical University of Munich
- Diseases
- Ovarian cancer
- NCT number
- NCT02087592
What you commit to
- Study type: Interventional
- Participants enrolled: 69
- From Feb 2014 to the primary completion date, Nov 2014
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- severe concomitant disease which prevents from participating in the group interventions
Other illness
- metastatic tumor disease
- clinically limiting cardiovascular or respiratory disease
- food allergies which prevent from mediterranean diet
Age
- life expectancy \<3 years
Other
- significant orthopedic disability which prevents from participating in the exercise training
- Karnofsky index \<60
- VO2max \>150%
- Maximal exercise capacity \< 50 W
- 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
Who the study is looking for
- women with proven pathogenic BRCA1/2 mutation
Age in the registry: 18 years to 69 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| University of Schleswig-Holstein Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Technische Universitaet Muenchen Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.