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Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

NCT02087592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-04-16

No results posted yet for this study

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.

Conditions

  • Hereditary Breast and Ovarian Cancer

Interventions

BEHAVIORAL

Structured exercise training plus mediterranean diet

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Marion Kiechle, Prof. Dr. · Technical University of Munich

  • Martin Halle, Prof. Dr. · Technical University of Munich

  • Stephan C Bischoff, Prof. Dr. · Universitaet Hohenheim, Stuttgart

  • Wolf-Dieter Gerber, Prof. Dr. · Universitaetsklinikum Schleswig-Holstein, Campus Kiel

  • Markus Loeffler, Prof. Dr. · University of Leipzig

  • Christoph Engel, Dr. · University of Leipzig

  • Rita K Schmutzler, Prof. Dr. · University of Cologne

  • Alfons Meindl, Prof. Dr. · Technical University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-11-30
Completion
2024-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02087592 on ClinicalTrials.gov