Loading clinical trials...

Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers | Clinical Trials | Clareo Health

RECRUITINGNA

Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

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

NCT02516540•Technical University of Munich

View on ClinicalTrials.gov

Summary

The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Detailed Description

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 efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•proven pathogenic BRCA1/2 mutation
•age \>=18
•written informed consent

Exclusion Criteria

•current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
•metastatic tumor disease
•life expectancy \<3 years
•clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
•significant orthopedic disability which prevents from participating in the group interventions
•severe concomitant diseases which prevents from participating in the group interventions
•Karnofsky index \<60
•maximum exercise capacity \<50 W
•food allergies which prevent from mediterranean diet
•vegan diet
+5 more criteria

Locations (19)

Humboldt Universität zu Berlin

Berlin, Germany

Uniklinikum Köln

Cologne, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Kliniken Essen-Mitte

Essen, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Key Dates

Start Date

March 1, 2015

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

April 11, 2024

Enrollment

600

ESTIMATED participants

Conditions

Hereditary Breast and Ovarian Cancer

Interventions

Structured exercise training plus mediterranean diet

BEHAVIORAL

Contacts

Marion Kiechle, Prof. Dr.

CONTACT

+49 89 4140 2420 marion.kiechle@tum.de

Daniela Schemmer

CONTACT

+49 89 4140 2433 Daniela.Schemmer@mri.tum.de

Familial Investigations of Childhood Cancer Predisposition

NCT03050268

Acute LeukemiaAdenomatous Polyposis+44 more

View study

RECRUITINGNA

CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

NCT05130606

Hereditary Breast and Ovarian Cancer

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Inclusion Criteria

Exclusion Criteria

Familial Investigations of Childhood Cancer Predisposition

CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study

Statewide Communication to Reach Diverse Low Income Women

Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers