Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Hereditary Breast and Ovarian Cancer Clinical Trial

— LIBRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087592
• Other study ID #: LIBRE-F-110013
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 2024
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Neoplasms

Intervention

Behavioral:
• Structured exercise training plus mediterranean diet

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne
Germany	University of Schleswig-Holstein Campus Kiel	Kiel
Germany	Technische Universitaet Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric parameters (waist and hip circumference, skinfold measurements)		3 months
Other	Body composition (body impedance analysis)		3 months
Other	Eating behaviour		3 months
Other	Laboratory parameters		3 months
Other	Aerobic exercise capacity during ergometry		3 months
Primary	Number of patients successfully completing the intervention program		3 months
Secondary	Stress coping capacity (TICS)		3 months
Secondary	Grade of optimism (LOT)		3 months
Secondary	Body mass index as a marker of caloric balance		3 months
Secondary	Total fat intake		3 months
Secondary	maximum exercise capacity (VO2max) as a marker of physical fitness		3 months
Secondary	Quality of life (SF-36)		3 months
Secondary	Physical activity (IPAQ questionnaire)		3 months

External Links

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