Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2014 by Technische Universität München
Sponsor:
Technische Universität München
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT02087592
First received: March 12, 2014
Last updated: August 5, 2014
Last verified: August 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hereditary Breast and Ovarian Cancer |
Behavioral: Structured exercise training plus mediterranean diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Technische Universität München:
Primary Outcome Measures:
- Number of patients successfully completing the intervention program [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Stress coping capacity (TICS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Grade of optimism (LOT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Body mass index as a marker of caloric balance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Total fat intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- maximum exercise capacity (VO2max) as a marker of physical fitness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Quality of life (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Physical activity (IPAQ questionnaire) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Anthropometric parameters (waist and hip circumference, skinfold measurements) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Body composition (body impedance analysis) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Eating behaviour [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Laboratory parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Aerobic exercise capacity during ergometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2014 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Usual standard of care
|
|
|
Experimental: Intervention
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
|
Behavioral: Structured exercise training plus mediterranean diet |
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02087592
Please refer to this study by its ClinicalTrials.gov identifier: NCT02087592
Contacts
| Contact: Marion Kiechle, Prof. Dr. | +49 89 4140 2420 | marion.kiechle@lrz.tu-muenchen.de | |
| Contact: Sabine Brandhorst | +49 89 4140 2433 | Sabine.Brandhorst@mri.tum.de |
Locations
| Germany | |
| University of Cologne | Recruiting |
| Cologne, Germany | |
| Principal Investigator: Rita K Schmutzler, Prof. Dr. | |
| University of Schleswig-Holstein Campus Kiel | Recruiting |
| Kiel, Germany | |
| Principal Investigator: Wolf-Dieter Gerber, Prof. Dr. | |
| Technische Universitaet Muenchen | Recruiting |
| Munich, Germany | |
| Principal Investigator: Marion Kiechle, Prof. Dr. | |
Sponsors and Collaborators
Technische Universität München
Investigators
| Principal Investigator: | Marion Kiechle, Prof. Dr. | Technische Universität München | |
| Study Director: | Martin Halle, Prof. Dr. | Technische Universität München | |
| Study Director: | Stephan C Bischoff, Prof. Dr. | Universitaet Hohenheim, Stuttgart | |
| Study Director: | Wolf-Dieter Gerber, Prof. Dr. | Universitaetsklinikum Schleswig-Holstein, Campus Kiel | |
| Study Director: | Markus Loeffler, Prof. Dr. | University of Leipzig | |
| Study Director: | Christoph Engel, Dr. | University of Leipzig | |
| Study Director: | Rita K Schmutzler, Prof. Dr. | University of Cologne | |
| Study Director: | Alfons Meindl, Prof. Dr. | Technische Universität München |
More Information
Additional Information:
No publications provided
| Responsible Party: | Technische Universität München |
| ClinicalTrials.gov Identifier: | NCT02087592 History of Changes |
| Other Study ID Numbers: | LIBRE-F-110013 |
| Study First Received: | March 12, 2014 |
| Last Updated: | August 5, 2014 |
| Health Authority: | Germany: Ethics Committee |
Keywords provided by Technische Universität München:
|
hereditary breast and ovarian cancer (HBOC) BRCA1/2 mutation carriers Mediterranean diet Structured exercise training prevention |
Additional relevant MeSH terms:
|
Hereditary Breast and Ovarian Cancer Syndrome Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Genital Diseases, Female Genital Neoplasms, Female |
Gonadal Disorders Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Urogenital Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015