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Background Women with highly penetrant BRCA mutations have a 55–60% lifetime risk for breast cancer and a 16–59% lifetime risk for ovarian cancer. However, penetrance differs interindividually, indicating that environmental and behavioral factors may modify this risk. These include lifestyle factors such as physical activity status, dietary habits, and body weight. The modification of penetrance by changing lifestyle factors has not thus far been investigated in a randomized trial in BRCA mutation carriers. Methods Therefore, we intend to enroll 60 BRCA1/2 mutation carriers in a pilot feasibility study (Lifestyle Intervention Study in Women with Hereditary Breast and Ovarian Cancer (LIBRE) pilot). This multi-center, prospective, controlled trial aims to randomize (1:1) participants into a (1) multi-factorial lifestyle intervention group (IG) versus (2) the control group with usual care (CG). The primary endpoint is feasibility and acceptance of a structured interdisciplinary lifestyle intervention program over 12 months (at least 70% of the patients to complete the 1-year intervention). Furthermore, the effects on physical fitness, BMI, quality of life, and stress coping capacity will be investigated. During the first 3 months, women in the IG will receive structured, individualized and mainly supervised endurance training of ≥18 MET*h/week (MET = metabolic equivalent task) and personal nutritional counseling based on the Mediterranean diet. During the subsequent 9 months, the IG will receive monthly group training sessions and regular telephone contacts for motivation, whereas the CG will only receive usual care (one general counseling on healthy nutrition and benefits of regular physical activity on health status). At randomization and subsequent time points (3, 6, 12 months), cardiopulmonary fitness will be assessed by spiroergometry and nutritional and psychological status by validated questionnaires. Discussion This pilot study will investigate the optimal strategy to improve physical fitness, nutritional habits, and psychological factors in women at high risk for developing breast or ovarian cancer. The results of this pilot feasibility study will be the basis for a larger prospective randomized trial including clinical events (LIBRE). Trial registration ClinicalTrials.gov, NCT02087592

Migräne ist eine familiär gehäuft auftretende Erkrankung. Das Ziel dieser Studie war daher, Familien mit einem Migränekind und einer Mutter mit Migräne (N=30) mit gesunden Familien (N=20) bezüglich der Zusammenhänge zwischen spezifischen neurophysiologischen pathogenetischen Mechanismen der Migräne, wie auffällige Reizverarbeitung und erhöhte kortikale Exzitabilität, einerseits und Familieninteraktionen und Persönlichkeitsmerkmalen, wie Neurotizismus und Extraversion, andererseits zu vergleichen. Die Korrelationsanalyse und Faktorenanalyse ergaben, daß die Störung der Habituation der Contingenten Negativen Variation (CNV) um so ausgeprägter und die Neurotizismuswerte bei den Migränekindern um so höher waren, je mehr Kontrolle und selbständigkeitshemmende Verhaltensweisen Migränekinder seitens ihrer Eltern erlebten. Die CNV-Amplitude war relativ unabhängig vom Erziehungsstil in der Familie und durch Ähnlichkeiten in der Reizverarbeitung von Eltern und ihren Kindern charakterisiert, was eventuell auf genetische Faktoren zurückgeführt werden kann. In gesunden Familien konnten enge Zusammenhänge zwischen einzelnen Parametern der Eltern-Kind-Interaktionen festgestellt werden. Die Untersuchung weist darauf hin, daß die neurophysiologische Anfallsbereitschaft sowie Persönlichkeitsmerkmale bei Migräne von psychosozialen Faktoren wie Eltern-Kind-Interaktionen beeinflußt werden können, und daß verschiedene Parameter der Reizverarbeitung bei Patienten sowohl auf nicht genetische familiäre Bedingungen (CNV-Habituation) als auch auf genetische Faktoren (CNV-Amplitude) zurückgeführt werden können., Migraine is a familial disorder. The aim of this study was to compare the relationship between specific neurophysiologic pathogenetic mechanisms of migraine such as abnormal information processing and enhanced cortical excitability on the one hand, and parent-child-interactions and personality traits such as neuroticism and extraversion on the other hand in migraine and healthy families. The correlation and factor analyses demonstrated that the stronger the control over a child and the more intensive the suppression of a child's independence by a parent during a stressful situation in migraine families, the more pronounced the loss of habituation of the contingent negative variation (CNV), and the greater the neuroticism in a migraine child. The CNV amplitude was independent of psychosocial conditions in the family but represented similarities in information processing between parents and their children suffering from migraine. This could be possibly explained by genetic influences on information processing in migraine. In healthy families only the relationship between parameters of parent-child-interaction could be observed. This investigation demonstrates that the neurophysiological disposition to a migraine attack as well as personality traits in migraine could be influenced by psychosocial factors such as parent-child interactions and that different parameters of information processing in headache patients are related to either non-genetic familial conditions (habituation) or functional genetic factors (amplitude).