Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Study Overview
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Brief Summary
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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 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.

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

Conditions
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Hereditary Breast and Ovarian Cancer

Intervention / Treatment
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* Behavioral: Structured exercise training plus mediterranean diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual standard of care | |
| Experimental: Intervention<br>Usual standard of care plus structured physical exercise training plus mediterranean-style diet | Behavioral: Structured exercise training plus mediterranean diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients successfully completing the intervention program |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hereditary breast and ovarian cancer (HBOC), BRCA1/2 mutation carriers, Mediterranean diet, Structured exercise training, prevention