Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers (LIBRE-2)

Technical University of Munich

Status: Enrolling

Conditions: Hereditary Breast and Ovarian Cancer

Treatments: Behavioral: Structured exercise training plus mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02516540

LIBRE-2-20150626

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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
• body mass index <15 kg/m2
• pregnancy
• insufficient knowledge of German language
• insufficient compliance
• active participation in other interventional trials

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Structured exercise training plus mediterranean diet