Lifestyle intervention for 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
This study tests if a structured program of exercise and a Mediterranean diet can help people with BRCA1/2 mutations improve their health and reduce their cancer risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Technical University of Munich Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 19 sites (Berlin and 18 other locations) |
| Trial ID | NCT02516540 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a structured lifestyle intervention program that combines exercise training with a Mediterranean diet for individuals carrying BRCA1/2 mutations. Over three years, participants will be randomized to assess improvements in diet adherence, body mass index reduction, and physical fitness levels. The study aims to provide evidence on how lifestyle changes can impact the health of those at increased risk for hereditary breast and ovarian cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a proven pathogenic BRCA1/2 mutation.
Not a fit: Patients currently undergoing chemotherapy or radiotherapy, or those with severe health conditions that limit participation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce cancer risk and improve overall health for BRCA1/2 mutation carriers.
How similar studies have performed: Previous studies have shown that lifestyle modifications can positively influence cancer risk factors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin and 18 other locations
- Humboldt Universität zu Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden — Dresden, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Kliniken Essen-Mitte — Essen, Germany (Recruiting)
- Universitätsklinikum Essen — Essen, Germany (Recruiting)
- Universitätsklinikum Freiburg — Freiburg, Germany (Recruiting)
- Universitätsmedizin Göttingen — Göttingen, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)
- Universitätsklinium Heidelberg — Heidelberg, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Germany (Recruiting)
- Uniklinikum Köln — Köln, Germany (Recruiting)
- Universitätsklinikum Leipzig — Leipzig, Germany (Not_yet_recruiting)
- Technische Universität München — München, Germany (Recruiting)
- Universität Regensburg — Regensburg, Germany (Recruiting)
- Interdisziplinäres Brustzentrum am Diakonieklinikum — Stuttgart, Germany (Recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Recruiting)
- Universität Ulm — Ulm, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Germany (Recruiting)
Study contacts
- Principal investigator: Anne S Quante, Dr. — Technical University of Munich
- Study coordinator: Marion Kiechle, Prof. Dr.
- Email: marion.kiechle@tum.de
- Phone: +49 89 4140 2420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.