Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hereditary Breast and Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Study participants are instructed regarding a healthy diet according to the recommendations of the German Nutrition Society (DGE) and are informed about positive effects of physical activity on incidence and prognosis of breast cancer

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet.

Group Type EXPERIMENTAL

Structured exercise training plus mediterranean diet

Intervention Type BEHAVIORAL

Structured exercise training plus mediterranean diet

Interventions

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Structured exercise training plus mediterranean diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* body mass index \<15 kg/m2
* pregnancy
* insufficient knowledge of German language
* insufficient compliance
* active participation in other interventional trials

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No