Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study)

Abstract

BackgroundWomen 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.MethodsTherefore, 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT02087592

Evaluation of the quality of life of ovarian cancer patients in the context of selected quantitative variables such as body mass, number of miscarriages and time from diagnosis

“…kiechle et al undertook studies evaluating the strategy of physical fitness, eating habits and psychological factors in women at high risk of developing breast or ovarian cancer. The results of this pilot feasibility study will be the basis for a broader prospective randomised trial including clinical events [13].…”

Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers – an interventional randomized controlled multicenter trial (LIBRE-1)

“…‘LIBRE-1’ ( L ifestyle I ntervention study in women with hereditary Bre ast and ovarian cancer, 1 = pilot) [ 19 ] is a multicenter, prospective, two-armed randomized (1:1) controlled clinical trial including women with germline mutations in BRCA1 or BRCA2 . The primary aim of this study was to evaluate adherence to and acceptance of a structured, 1-year exercise program combined with a Mediterranean dietary pattern.…”

“…The primary aim of this study was to evaluate adherence to and acceptance of a structured, 1-year exercise program combined with a Mediterranean dietary pattern. A detailed description of the study design has been published [ 19 ]. The study has been registered at ClinicalTrials.gov (reference: NCT02087592).…”

“…Exclusion criteria were medical problems not allowing exercise, e.g. metastatic tumor disease, cardiovascular and lung diseases or severe orthopedic problems; food allergies not allowing consumption of a Mediterranean diet; women who regularly exercise, pregnancy; BMI < 18 kg/m 2 [ 19 ].…”

“…Randomization was stratified by center and previous diagnosis of cancer. While the CG received an introductory lecture on the positive effects of physical activity on the incidence and prognosis of breast cancer as well as a group lesson on healthy eating based on the recommendations of the German Nutrition Society (DGE), the IG received a structured lifestyle intervention program of increasing physical activity and over 12 months (3 months intensive phase followed by 9 months less intense supervision) [ 19 ]. Psychological support was not given, but was monitored by questionnaires (SSCS, EORTC QLQ-C30/−BR23, details see below) as were nutrition habits and level of physical activity.…”