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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02087592
Other study ID # LIBRE-F-110013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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