Citations

Background Ontuxizumab, a humanized monoclonal antibody, targets endosialin (tumor endothelial marker 1 [TEM‐1] or CD248), which is expressed on sarcoma cells and is believed to be involved in tumor angiogenesis. This is the first trial to evaluate ontuxizumab in patients with sarcoma. Methods Part 1 was an open‐label, dose‐finding, safety lead‐in: 4, 6, or 8 mg/kg with gemcitabine and docetaxel (G/D; 900 mg/m 2 gemcitabine on days 1 and 8 and 75 mg/m 2 docetaxel on day 8). In part 2, patients were randomized in a double‐blind fashion in 2:1 ratio to ontuxizumab (8 mg/kg) or a placebo with G/D. Randomization was stratified by 4 histological cohorts. Results In part 2 with 209 patients, no significant difference in progression‐free survival between ontuxizumab plus G/D (4.3 months; 95% confidence interval [CI], 2.7‐6.3 months) and the placebo plus G/D (5.6 months; 95% CI, 2.6‐8.3 months) was observed ( P = .67; hazard ratio [HR], 1.07; 95% CI, 0.77‐1.49). Similarly, there was no significant difference in median overall survival between the 2 groups: 18.3 months for the ontuxizumab plus G/D group (95% CI, 16.2‐21.1 months) and 21.1 months for the placebo plus G/D group (95% CI, 14.2 months to not reached; P = .32; HR, 1.23; 95% CI, 0.82‐1.82). No significant differences between the treatment groups occurred for any efficacy parameter by sarcoma cohort. The combination of ontuxizumab plus G/D was generally well tolerated. Conclusions Ontuxizumab plus G/D showed no enhanced activity over chemotherapy alone in soft‐tissue sarcomas, whereas the safety profile of the combination was consistent with G/D alone.

The purpose of the present study was to examine characteristics of multi-ingredient pre-workout supplement (MIPS) users, their common patterns/habits of MIPS ingestion, and their associated feelings about the effectiveness and safety of this class of supplements. An online electronic survey was distributed through social media to assess self-reported supplementation practices and preferences among adult males and females who reported regular MIPS use. A total of 1045 individuals responded, with 872 of these individuals (males: n = 636, 72.9%; females: n = 233, 26.7%; mean ± SD; age = 27.7 ± 7.9 years; training age = 8.2 ± 7.3 years) completing the survey. The majority of respondents reported the length of current or past MIPS consumption as greater than one year (n = 630, 72.2%), with ingestion frequencies primarily of four (n = 210, 24.1%) or five (n = 212, 24.3%) days per week of training. In addition, the three most popular goals for ingesting MIPS were increased energy and focus (n = 776, 89.0%), muscular endurance (n = 325, 37.3%), and blood flow or “pump” (n = 322, 37.0%). Although most users reported ingesting one serving size with each use, 14% reported ingesting two or more, and 18% indicated they ingest MIPS more than once per day. Importantly, over half (54%) of the respondents reported experiencing side-effects following MIPS use, including skin reactions, heart abnormalities, and nausea. Females were more likely than males to experience these side effects, despite being less likely to consume two or more serving sizes per dose. Our findings also indicated that MIPS users should consume no more than the recommended serving size of a given supplement, as the potentially significant variability in the caffeine content of MIPS products is compounded as more doses are consumed. Furthermore, MIPS users should minimize the ingestion of other supplements which contain high levels of niacin and caffeine, as the concurrent consumption of such products may put users above the tolerable upper limits for these substances.

OBJECTIVES: We conducted a randomized, placebo-controlled trial, which evaluated a novel formulation of caraway oil and L-menthol using microsphere-based site-specific targeting (COLM-SST) vs placebo in patients with functional dyspepsia (FD). METHODS: Adult men and women with FD defined by Rome III criteria were recruited. Patients were randomized to COLM-SST (25 mg of caraway oil and 20.75 mg of L-menthol per capsule, at 2 capsules per dose, twice per day) or placebo. Efficacy was measured at 24 hours, 2 weeks, and 4 weeks. Patients were allowed to take concomitant medications for their FD throughout the trial, and rescue medicines were allowed, 48 hours after start of dosing. RESULTS: Ninety-five patients were enrolled (mean age = 43.4 years; 75.8% women). At 24 hours, the active arm reported a statistically significant reduction in postprandial distress syndrome symptoms ( P = 0.039), and a nonsignificant trend toward benefit of epigastric pain syndrome symptoms ( P = 0.074). In patients with more severe symptoms, approximately 3 quarters of patients showed substantial global improvement (i.e., clinical global impressions), after 4 weeks of treatment, vs half in the control arm. These differences were statistically significant for patients with epigastric pain syndrome ( P = 0.046), and trending toward significance for patients with postprandial distress syndrome ( P = 0.091). There was no statistically significant difference between groups for Global Overall Symptom scores for the overall population at 2 and 4 weeks. Treatment emergent adverse events were mild to moderate, and no serious adverse events were reported. DISCUSSION: In patients taking their usual medications for FD, COLM-SST provided rapid relief (within 24 hours) and relief of severe FD symptoms. It was safe and well tolerated.

Abstract Currier, BS, Harty, PS, Zabriskie, HA, Stecker, RA, Moon, JM, Jagim, AR, and Kerksick, CM. Fat-free mass index in a diverse sample of male collegiate athletes. J Strength Cond Res 33(6): 1474–1479, 2019—Fat-free mass index (FFMI) is a body composition metric that has been used to assess relative muscularity in athletes. Fat-free mass index is calculated by dividing FFM by height squared, although further height corrections through linear regression may be needed in taller individuals. This study reported height-adjusted FFMI (FFMI Adj ) data in 209 male collegiate athletes from 10 sports (baseball, cross country, football, golf, ice hockey, weightlifting, rugby, swimming, track and field, and water polo) and the FFMI Adj natural upper limit for sports with sufficient sample size. The body composition of all subjects (mean ± SD ; age: 20.7 ± 1.9 years, height: 182.9 ± 6.7 cm, body mass: 90.8 ± 16.8 kg, and percent body fat: 15.6 ± 5.3) was measured using dual-energy x-ray absorptiometry. Linear regression was used to adjust for height, and the FFMI Adj natural upper limit was determined by calculating the 97.5th percentile of all values. One-way analyses of variance with Games-Howell post hoc comparisons were used to determine between-sport differences. A paired-samples t -test revealed a significant difference ( p < 0.001) between unadjusted and adjusted mean FFMI values. The overall mean FFMI Adj was 22.8 ± 2.8 kg·m −2 . Significant between-sport differences ( p < 0.001) in FFMI Adj were identified. Average FFMI Adj was highest in football athletes (24.28 ± 2.39 kg·m −2 ) and lowest in water polo athletes (20.68 ± 3.56 kg·m −2 ). The FFMI Adj upper limit was calculated for all athletes (28.32 kg·m −2 ), rugby (29.1 kg·m −2 ), and baseball (25.5 kg·m −2 ). This study reported FFMI Adj values in a diverse cohort of male collegiate athletes, providing data for the first time in several sports. These values can be used to guide nutritional and exercise interventions, predict athletic performance, and provide coaches with standardized information regarding the potential for further FFM accretion in male athletes.