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Completed

NCT Number: NCT02087592

Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

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.

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Key information

Conditions

Hereditary Breast and Ovarian Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Syndrome Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cologne, Cologne, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured exercise training plus mediterranean diet

Behavioral

Primary outcomes

  1. Number of patients successfully completing the intervention program

    Time frame: 3 months

Secondary outcomes

  1. Stress coping capacity (TICS)

    Time frame: 3 months

  2. Grade of optimism (LOT)

    Time frame: 3 months

  3. Body mass index as a marker of caloric balance

    Time frame: 3 months

  4. Total fat intake

    Time frame: 3 months

  5. maximum exercise capacity (VO2max) as a marker of physical fitness

    Time frame: 3 months

  6. Quality of life (SF-36)

    Time frame: 3 months

  7. Physical activity (IPAQ questionnaire)

    Time frame: 3 months

Other outcomes

  1. Anthropometric parameters (waist and hip circumference, skinfold measurements)

    Time frame: 3 months

  2. Body composition (body impedance analysis)

    Time frame: 3 months

  3. Eating behaviour

    Time frame: 3 months

  4. Laboratory parameters

    Time frame: 3 months

  5. Aerobic exercise capacity during ergometry

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: LIBRE

Important dates

Study start
2014
Primary completion
2014
Study completion
2024
First posted
Mar 14, 2014
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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