Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

  • STATUS
    Recruiting
  • End date
    Mar 25, 2025
  • participants needed
    600
  • sponsor
    Technische Universität München
Updated on 25 April 2021

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.

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.

Details
Condition Hereditary Breast and Ovarian Cancer, Hereditary Breast and Ovarian Cancer Syndrome
Treatment Structured exercise training plus mediterranean diet
Clinical Study IdentifierNCT02516540
SponsorTechnische Universität München
Last Modified on25 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Hereditary Breast and Ovarian Cancer?
Do you have any of these conditions: Hereditary Breast and Ovarian Cancer Syndrome or Hereditary Breast and Ovarian Cancer?
Do you have any of these conditions: Hereditary Breast and Ovarian Cancer Syndrome or Hereditary Breast and Ovarian Cancer?
Do you have any of these conditions: Hereditary Breast and Ovarian Cancer Syndrome or Hereditary Breast and Ovarian Cancer?
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
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