An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial.

BACKGROUND: Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy. PRIMARY OBJECTIVES: To evaluate the study design, feasibility, safety, and acceptance of combined nutrition and exercise in patients diagnosed with ovarian cancer during and after first-line chemotherapy. STUDY HYPOTHESIS: Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy. TRIAL DESIGN: A 1:1 RCT with an intervention group and a control group. The intervention group receives an exercise and nutrition program whereas the control group continues to follow the usual care. MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion: women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery. Exclusion: Eastern Cooperative Oncology Group (ECOG) status of 2 or worse. PRIMARY ENDPOINTS: Recruitment rate, completion rate, side effects, and adherence. SAMPLE SIZE: n=30 patients (15 per arm) will be recruited. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is planned for the end of 2019. Results will be presented in the months following study completion 1 year after recruitment has been finalised. TRIAL REGISTRATION NUMBER: The pilot phase was approved by the ethics committee of the Medical Faculty of Hamburg on December 13, 2017 (PV5456). The study was registered on September 9, 2018 at the German Study Registry for Clinical Studies (DRKS00013231).

Prognostic associations of circulating phytoestrogens and biomarker changes in long-term survivors of postmenopausal breast cancer.

Lignans are associated with improved postmenopausal breast cancer (BC) survival, but whether these associations, particularly with enterolactone (major lignan metabolite), persist over time is unclear. Little is known about other phytoestrogens on prognosis in long-term survivors. The study examines associations of prognosis with 1) circulating postdiagnosis enterolactone, 2) eight circulating phytoestrogen metabolites, and 3) changes in enterolactone and genistein. In a German cohort of 2,105 postmenopausal BC patients with blood samples collected at recruitment 2002-2005 (baseline) and re-interview in 2009 (follow-up), delay-entry Cox proportional hazards regression was used. Landmark analysis showed that circulating enterolactone (log2) associations with 5-year survival changed over time, with strongest hazard ratios of 0.89 (95% CI, 0.80-0.99) at blood draw (BD) and 0.86 (0.77-0.97) at 2 years post-BD for BC mortality, and 0.87 (0.80-0.95) at BD and 0.84 (0.76-0.92) at 3 years post-BD for all-cause mortality, which attenuated thereafter. In long-term survivors, increasing concentrations of genistein (1.17, 1.01-1.36), resveratrol (1.19, 1.02-1.40), and luteolin (1.96, 1.07-3.58) measured in follow-up blood samples were associated with poorer subsequent prognosis. Neither enterolactone at follow-up nor changes in enterolactone/genistein were associated with prognosis. Large long-term longitudinal studies with multiple phytoestrogen measurements are required to understand long-term effects of phytoestrogens after BC.

Immunization coverage in young children: a study nested into a health and demographic surveillance system in Burkina Faso.

BACKGROUND: Reliable estimates of immunization coverage are the basis for rational policy making, program implementation and evaluation. Vaccination coverage is usually measured using administrative data or surveys, both having a number of methodological problems. METHODS: We estimated vaccination coverage using a data set of 11 906 children aged <5 years from an existing Health and Demographic Surveillance System (HDSS) in north-western Burkina Faso. Data were collected from September 2008 to December 2009. RESULTS: Vaccination coverage based on information from existing vaccination cards ranged from 80% (measles) to 94% (OPV1). When taking into consideration all information available (including BCG scars in children with and without vaccination card), full coverage in children aged 12-23 months was around 75%, with a significantly higher coverage in rural compared with urban areas. There were no differences in vaccination coverage between boys and girls. CONCLUSION: The study supports other studies that found vaccination coverage improvement in Burkina Faso recently. In addition, our study found slightly better vaccination coverage in rural compared with urban areas, which needs further consideration.

Plasma 25-hydroxyvitamin D3, folate and vitamin B12 biomarkers among international colorectal cancer patients: a pilot study.

Vitamin D and folate are associated with decreased colorectal cancer risk and their association with colorectal cancer prognosis is under investigation. We assessed the levels of plasma 25-hydroxyvitamin D3 (25(OH)D3), folate and vitamin B12 in an international pilot study in order to determine variability of these biomarkers based on geographical location. Plasma 25(OH)D3, folate and vitamin B12 concentrations were measured in 149 invasive, newly diagnosed colorectal cancer cases from Heidelberg (Germany), Seattle (WA, USA), and Tampa (FL, USA) and in ninety-one age- and sex-matched controls. Their associations with potential predictors were assessed using multivariate linear regression analyses. Plasma 25(OH)D3, folate and vitamin B12 concentrations differed by location. Other predictors were season for 25(OH)D3 and tumour stage (vitamin B12). Season-corrected average 25(OH)D3 concentrations were higher in Heidelberg (31·7 ng/ml; range 11·0-83·0 ng/ml) than in Seattle (23·3 ng/ml; range 4·0-80·0 ng/ml) and Tampa (21·1 ng/ml; range 4·6-51·6 ng/ml). In Heidelberg, a strong seasonal variation was observed. Folate (11·1 ng/ml) and vitamin B12 (395 pg/ml) concentrations in Heidelberg were lower than those in Seattle (25·3 ng/ml and 740 pg/ml, respectively) and Tampa (23·8 ng/ml and 522 pg/ml, respectively). Differences in plasma 25(OH)D3 and folate concentrations between Heidelberg and the US sites were observed, probably reflecting variation in outdoor activities and sun-avoidance behaviour during summer as well as in folic acid fortification and supplement use. Intra-site differences at each study location were greater than between-location variability, suggesting that individual health behaviours play a significant role. Nevertheless, the intra-site differences we observed may be due to chance because of the limited sample size. Our pilot study illustrates the value of an international cohort in studying colorectal cancer prognosis to discern geographical differences in a broad range of exposures.

Sex-specific responses to zinc supplementation in Nouna, Burkina Faso.

OBJECTIVES: To study the different responses by sex to zinc supplementation among young children. STUDY CHILDREN AND METHODS: Double-blind randomized controlled trial of zinc supplementation in 686 children aged 6-30 months, conducted in Nouna, a rural area of Burkina Faso. Children received either a 12.5-mg zinc sulfate tablet or a placebo every day for about 6 months. Outcomes were morbidity, nutritional status, and mortality. RESULTS: Results revealed significant differences between boys and girls in their responses to zinc supplementation. Boys who received the zinc preparation had fewer days with diarrhea than did control boys (RR = 0.88, P = 0.05), especially less nonfebrile diarrhea (RR = 0.72, P < 0.001) and less dysentery (RR = 0.65, P = 0.05), but more ear infections (RR = 4.00, P < 0.001). By contrast, girls who received the zinc supplement had the same prevalence of diarrhea as did control girls, but more dysentery (RR = 3.70, P < 0.001), fewer ear infections (RR = 0.39, P < 0.001), and fewer eye infections (RR = 0.41, P < 0.001). The effect of supplementation on nutritional status was not detectable in boys, but girls who received supplementation experienced a faster growth velocity in height than did control girls (P = 0.004) and a faster growth velocity for weight and height if they were wasted and not stunted at baseline (P = 0.003). CONCLUSIONS: Zinc supplementation had positive, nil, or negative effects depending on pathological condition, and the effects were different for boys than for girls.