Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue

BACKGROUND: Common acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT. METHODS: A phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect. RESULTS: From September 20, 2010, to October 20, 2012, 54 participants enrolled with 80% retention and 94% self-reported compliance. There were no grade 4-5 toxicities, and the incidence of grade 2-3 toxicities was similar between treatment arms, the most common of which were anxiety and nausea (15%), headaches (19%), and insomnia (20%). There were no statistically significant differences in end-RT or 4 week post-RT outcomes between armodafinil and placebo in any outcomes (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, Brief Fatigue Inventory, Epworth Sleepiness Scale, FACT-Brain, and FACIT-cognitive function). However, in participants with more baseline fatigue, those treated with armodafinil did better than those who received the placebo on the end-RT assessments for several outcomes. CONCLUSION: Armodafinil 150 mg/day was well tolerated in primary brain tumor patients undergoing RT with good compliance. While there was no overall significant effect on fatigue, those with greater baseline fatigue experienced improved QOL and reduced fatigue when using armodafinil. These data suggest that a prospective, phase III randomized trial is warranted for patients with greater baseline fatigue

How do practitioners characterize land tenure security?

Improving land tenure security (LTS) is a significant challenge for sustainable development. The Sustainable Development Goals and other recent global initiatives have renewed and increased the need to improve LTS to address climate change, biodiversity loss, food security, poverty reduction, and other challenges. At the same time, policymakers are increasingly interested in evidence- based policies and decisions, creating urgency for practitioners and researchers to work together. Yet, incongruent characterizations of LTS (identifying the key components of LTS) by practitioners and researchers can limit collaboration and information flows necessary for research and effective policymaking. While there are systematic reviews of how LTS is characterized in the academic literature, no prior study has assessed how practitioners characterize LTS. We address this gap using data from 54 interviews of land tenure practitioners working in 10 countries of global importance for biodiversity and climate change mitigation. Practitioners characterize LTS as complex and multifaceted, and a majority of practitioners refer to de jure terms (e.g., titling) when characterizing it. Notably, in our data just one practitioner characterized LTS in terms of perceptions of the landholder, contrasting the recent emphasis in the academic literature on landholder perceptions in LTS characterizations. Researchers should be aware of incongruence in how LTS is characterized in the academic literature when engaging practitioners.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/155485/1/csp2186.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/155485/2/csp2186_am.pd

The prevalence of disordered eating in elite male and female soccer players

PurposeTo examine the prevalence of disordered eating (DE) in elite male and female soccer players and the influence of perfectionism.MethodsUsing a cross-sectional design, elite male (n = 137) and female (n = 70) soccer players and non-athlete controls (n = 179) completed the clinical perfectionism questionnaire (CPQ-12) and the eating attitudes test (EAT-26) to assess perfectionism and DE risk, respectively.ResultsMale soccer players had higher EAT-26 scores than controls (10.4 ± 9.9 vs. 6.8 ± 6.7; P = 0.001), but there were no differences in the prevalence of clinical levels of DE (EAT-26 score ≥ 20) (15 vs. 5%, respectively; X2 = 0.079) The proportion of females with DE risk was higher in controls [EAT-26: 13.9 ± 11.6 (25% of population)] than female players [EAT-26: 10.0 ± 9.0% (11% of population)] (X2 = 0.001). With linear regression, perfectionism explained 20% of the variation in DE risk in males (P = 0.001); in females, athletic status (player vs. control) and perfectionism were significant predictors of DE risk, explaining 21% of the variation (P = 0.001). Male reserve team players had higher EAT-26 (+ 3.5) and perfectionism (+ 2.7) scores than first-team players (P ConclusionsThe prevalence of DE risk was not different in elite male and female soccer players; in fact, the prevalence was greatest in non-athlete female controls. Perfectionism is a significant predictor of DE risk in males and females.Level of evidenceIII, case–control study.</div

Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609

6564 Background: Clinical trial accrual rates are lower among minority patients. Wake Forest CCOP RB protocol 97609 designed to accrue 400 non-Hispanic White (NHW) and 600 minority patients to a study evaluating potential genomic single nucleotide polymorphisms as markers for breast radiosensitivty. Methods: Accrual data evaluated from 24 participating CCOPs and numerous CTSU sites. Race / ethnicity self-reported by participants (NHW, non-Hispanic Black, Hispanic/Latino, Asian /Pacific Islander, or American Indian/Alaskan Native) based on ACS reporting criteria. Results: 752 participants accrued in 14.5 mths (11/11-1/13); 402 NHW and 350 minorities. NHW accrual goal reached, 5.9 months (period 1; avg 68.4 participants /month) compared with 54 minority participants (period 1; avg 9.2 participants / month). This 7.4 ratio NHW to minority accrual is higher than expected given incidence. During 8.6 months following closure NHW enrollment (period 2), 296 minority participants accrued (avg 34.3 participants/month). An almost 4-fold increase in minority accrual raises question of accrual disparity. 19 CCOPs open in period 1 and 24 CCOPs in period 2. CTSU contributed both periods, more CTSU sites were added during period 2. Excluding all CTSU sites and five CCOPs open only in period 2, the avg minority accrual:6.8 patients / month period 1 and 10.6 patients / month period 2. The average time of accrual was 4.0 months period 1 and 8.6 months period 2 due to variable opening dates at sites. Taking time into account, the avg minority accrual rate was 0.60 patients / month / site in period 1 and 0.56 patients / site / month in period 2. CCOP minority accrual rates in period 1 vs. 2 increased 11 / 19 sites, decreased 6 / 19, and remained the same in 2 / 19, p = .33. Conclusions: Despite closure of enrollment of NHWs into this study with a specific goal to accrue a large minority population, there was no increase in the rate of minority accrual. The initial appearance of an accrual bias can be attributed to the addition of sites and variable lengths of accrual time at sites. It is unknown whether overall lower minority accrual rate compared to NHWs is participant-, provider-, or population-based. Clinical trial information: NCT01407770

DNA methylation signatures in airway cells from adult children of asthmatic mothers reflect subtypes of severe asthma

Maternal asthma (MA) is among the most consistent risk factors for asthma in children. Possible mechanisms for this observation are epigenetic modifications in utero that have lasting effects on developmental programs in children of mothers with asthma. To test this hypothesis, we performed differential DNA methylation analyses of 398,186 individual CpG sites in primary bronchial epithelial cells (BECs) from 42 nonasthma controls and 88 asthma cases, including 56 without MA (NMA) and 32 with MA. We used weighted gene coexpression network analysis (WGCNA) of 69 and 554 differentially methylated CpGs (DMCs) that were specific to NMA and MA cases, respectively, compared with controls. WGCNA grouped 66 NMA-DMCs and 203 MA-DMCs into two and five comethylation modules, respectively. The eigenvector of one MA-associated module (turquoise) was uniquely correlated with 85 genes expressed in BECs and enriched for 36 pathways, 16 of which discriminated between NMA and MA using machine learning. Genes in all 16 pathways were decreased in MA compared with NMA cases (P = 7.1 × 10−3), a finding that replicated in nasal epithelial cells from an independent cohort (P = 0.02). Functional interpretation of these pathways suggested impaired T cell signaling and responses to viral and bacterial pathogens. The MA-associated turquoise module eigenvector was additionally correlated with clinical features of severe asthma and reflective of type 2 (T2)-low asthma (i.e., low total serum immunoglobulin E, fractional exhaled nitric oxide, and eosinophilia). Overall, these data suggest that MA alters diverse epigenetically mediated pathways that lead to distinct subtypes of severe asthma in adults, including hard-to-treat T2-low asthma