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Clinical Trials/NCT02087592
NCT02087592
Completed
Not Applicable

Prospective Randomized Multicenter Trial to Assess the Feasibility of a Structured Physical Exercise Training and Mediterranean-style Diet in Women With BRCA1/2 Mutations

Technical University of Munich3 sites in 1 country69 target enrollmentFebruary 2014
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ConditionsHereditary Breast and Ovarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hereditary Breast and Ovarian Cancer
Sponsor
Technical University of Munich
Enrollment
69
Locations
3
Primary Endpoint
Number of patients successfully completing the intervention program
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
April 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Technical University of Munich
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Number of patients successfully completing the intervention program

Time Frame: 3 months

Secondary Outcomes

  • Total fat intake(3 months)
  • Quality of life (SF-36)(3 months)
  • Physical activity (IPAQ questionnaire)(3 months)
  • Stress coping capacity (TICS)(3 months)
  • maximum exercise capacity (VO2max) as a marker of physical fitness(3 months)
  • Grade of optimism (LOT)(3 months)
  • Body mass index as a marker of caloric balance(3 months)

Study Sites (3)

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