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LIBRE II Study

The LIBRE study group, guided by Prof. Marion Kiechle works on a study named LIBRE-study.  The study is grand-aided by “Waltraut Bergmann Stiftung” and the “Deutsche Krebshilfe”. The study aims to investigate the influence of diet and physical activity on the development of breast cancer or recurrence of tumors in patients with a BRCA1 and BRCA2 mutation. For this, the biomarkers pro-Neurotensin and pro-Enkephalin will be measured observative to test their potential use in risk stratification, stratification for specific interventions and the patient follow-up.


The first phase of the study was successfully finalized regarding feasibility of the mentioned interventions. Meanwhile the LIBRE study entered a second phase, were a bigger study population is generated.

 

LIBRE Study

The study aims the description of the potential use of the biomarkers pro-neurotensin and pro-enkephalin in patients with BRCA1 or BRCA2 (high risk of developing breast- or ovarian cancer, 80% respectively 40%) for risk stratification, and stratification for specific interventions and the patient follow-up. The study is supposed to describes the influence of diet, physical activity and lifestyle on these patients.



Background: Women that have a hereditary dispositional (Germline mutation in the genes of BRCA1 or BRCA2) have a high risk to developing breast- or ovarian cancer in their live (80% respectively 40%). Despite that fact, not all women develop cancer. This gives an indication, that other factors can influence the risk of developing cancer. First observations show that less women become diseased if they were physical active in younger ages.


Breast cancer and physical activity: In non-hereditary breast cancer, the risk of cancer, so as the severity of the disease will we be critically influenced by diet and BMI. Many prospective studies demonstrated that physical activity on a regular basis is able to lower the risk of developing breast cancer by 25 %. Additionally the recurrence as well as mortality by breast cancer is lowered by 50 %. Even more advantages are found in the improvement of life quality, increase of fitness and a better tolerance to chemotherapy.


Breast cancer and diet: Diet can influence the risk of breast cancer development. Adiposity and weight gain higher the risk of developing breast cancer pre- and postmenopausal.  With a gain of more than 20 kg after the age of 18 years the risk of developing breast cancer duplicates. Women with a BMI of 30kg/m2  have a higher risk on developing metastasis and a higher risk of mortality. In a prospective study with breast cancer patients that received adjuvanive standard therapy, a calorie restriction and a fat-reduced diet had a significantly improved outcome.



Breast cancer and Soul: Risk factors for breast cancer are depression, a pessimistic attitude and negative stress compensation. Physical activity influences stress compensation and depression positively .The importance of a positive attitude is shown to have a great influence on feeling, health, stress reduction, mortality and a better recovery after a disease.



LIBRE Study: For women with the hereditary for breast- and ovarian cancer  there are no existing studies that include lifestyle. The foundation supports together with the “Deutsche Krebshilfe” a prospective study which should show that structured interventions in lifestyle, controlled diet, can improve nourishment, fitness, weight, quality of life and stress compensation. On top they want to show that changes in lifestyle can reduce the incidence of cancer und a better prognosis and less mortality. The study is set up in 2 phases whereas the first phase showed the feasibility of the interventions. All requirements for LIBRE I were fulfilled so LIBRE II can start with 600 patients in total, including them from all centers of family related breast and ovarian cancers of the “Deutsche Krebshilfe”.

Recurrence

Recurrence of a disease after the therapy was successful before. recurrence of tumors are called tumorrecurrence.

Observational study

Datas are collected prospective or respective without an intervention by for example therapy.

Pro-Neurotensin

Stable fragment of the peptide hormone “Neurotensin”. High levels of pro-Neurotensin are associated with a high risk of breast cancer.

Neurotensin

Peptide hormone for the processing of fat, and supports proliferation.

Pro-Enkephalin

Stabile fragment of the peptide hormone „Enkephalin“. Low values are associated with a higher risk of breast cancer.

Enkephalin

Endogenous opioid to reduce pain and a hormone with proapoptotic power (supports controlled cell death).

Interventionsstudie

Experimental study were interventions are planned (for example changes in lifestyle, different treatment of the patient).

Biomarker

Parameter on which predictive, prognostic or diagnosic evidence can be based on and that give information about a disease.

BRCA1/BRCA2

Tumor suppressor genes. Mutations in these genes causes to an ineffective DNA-repair system. This leads to easier changes in the cell which than can turn into tumor cells. Mutations in these genes are associated with a high risk of developing a malign tumor.