Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE)
This study is ongoing, but not recruiting participants.
Sponsor:
Technische Universität München
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT02087592
First received: March 12, 2014
Last updated: July 14, 2015
Last verified: July 2015
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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 ]
| Enrollment: | 69 |
| Study Start Date: | February 2014 |
| Estimated Study Completion Date: | June 2016 |
| Primary Completion Date: | November 2014 (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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02087592
Please refer to this study by its ClinicalTrials.gov identifier: NCT02087592
Locations
| Germany | |
| University of Cologne | |
| Cologne, Germany | |
| University of Schleswig-Holstein Campus Kiel | |
| Kiel, Germany | |
| Technische Universitaet Muenchen | |
| Munich, Germany | |
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:
| 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: | July 14, 2015 |
| Health Authority: | Germany: Ethics Commission |
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:
|
Ovarian Neoplasms Hereditary Breast and Ovarian Cancer Syndrome Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Breast Neoplasms Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 27, 2016