A Research Protocol for a Phase II Single-Arm Clinical Trial Assessing the Feasibility and Efficacy of Neoadjuvant Anastrozole in Patients With Luminal Breast Cancer and Low Proliferative Index: The ANNE Trial.

INTRODUCTION: Neoadjuvant endocrine therapy (NET) is recommended for the treatment of invasive breast cancer (BC), particularly luminal subtypes, in locally advanced stages. Previous randomized studies have demonstrated the benefits of aromatase inhibitors in this context. However, NET is typically reserved for elderly or frail patients who may not tolerate neoadjuvant chemotherapy. Identifying non-responsive patients early and extending treatment for responsive ones would be ideal, yet optimal strategies are awaited. AIMS: This non-randomized phase 2 clinical trial aims to assess NET feasibility and efficacy in postmenopausal stage II and III luminal BC patients, identifying predictive therapeutic response biomarkers. Efficacy will be gauged by patients with Ki67 ≤ 10% after 4 weeks and Preoperative Endocrine Prognostic Index (PEPI) scores 0 post-surgery. Study feasibility will be determined by participation acceptance rate (recruitment rate ≥50%) and inclusion rate (>2 patients/month). METHODS: Postmenopausal women with luminal, HER2-tumors in stages II and III undergo neoadjuvant anastrozole treatment, evaluating continuing NET or receiving chemotherapy through early Ki67 analysis after 2 to 4 weeks. The study assesses NET extension for up to 10 months, using serial follow-ups with standardized breast ultrasound and clinical criteria-based NET suspension. Clinical and pathological responses will be measured overall and in the luminal tumor A subgroup. Toxicity, health-related quality of life, and circulating biomarkers predicting early NET response will also be evaluated.

Influence of fasting during the night shift on next day eating behavior, hunger, and glucose and insulin levels: a randomized, three-condition, crossover trial.

AIMS: To investigate the influence of fasting during the night shift on eating behavior, hunger, glucose and insulin levels the following day. METHODS: Study with 10 male police officers who have been working at night. Participants were tested under three different conditions separated by at least 6 days of washout in a randomized, crossover design: "Night Shift Fasting" (NSF)-two nights of fasting during the night shift; "Night Shift Eating" (NSE)-two nights with the consumption of a standardized meal during the night shift (678 ± 42 kcal consumed at ~ 0200 h); and "Nighttime Sleep" (NS)-two nights of sleep. The morning after, blood glucose and insulin and hunger ratings were assessed, and food intake was assessed with an ad libitum test meal. Food intake was also assessed throughout the remainder of the day using a food record. Generalized Estimating Equations were used to analyze the effect of experimental condition. RESULTS: Food intake during the test meal, especially of proteins and fats, was higher after fasting during the night shift compared to the other conditions (p < 0.05), whereas desire to eat scores were lower after the NSF compared to NSE condition (p = 0.043). Hunger levels were lower after the NSF compared to the NS condition (p = 0.012). Insulin and HOMA-IR were also lower in the morning after NSF (p < 0.001). CONCLUSION: Fasting during the night shift leads to not only a higher intake of energy and macronutrients both in the early morning after work and throughout the next day, but also lower insulin levels and HOMA-IR in the morning. REGISTRATION NUMBER OF CLINICAL TRIAL: NCT03800732. Initial release: 01/09/2019. Last release: 02/23/2022.

Salivary spectral signature using ATR-FTIR spectroscopy in different exercise protocols.

The Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy (ATR-FTIR) has been applied to determine salivary biomarkers with high sensitivity and cost-effectiveness. Our study aimed to test the hypothesis that the spectral profile of saliva demonstrates distinct vibrational modes corresponding to different exercise protocols, thereby facilitating exercise monitoring. Saliva samples were collected from trained male subjects at three intervals: pre-exercise, post-exercise, and 3 h post-exercise. The protocols included acute sessions of continuous exercise (CE), high-intensity interval exercise (HIIE), and resistance exercise (RE). ATR-FTIR analysis revealed that salivary biochemical components changed uniquely with each exercise protocol. Specific spectral vibrational modes were identified as potential biomarkers for each exercise type. Notably, the salivary spectrum pattern of CE closely resembled that of HIIE, whereas RE showed minor alterations. Furthermore, we attempted to apply an algorithm capable of distinguishing the spectral range that differentiates the exercise modalities. This pioneering study is the first to compare changes in saliva spectra following different exercise protocols and to suggest spectrum peaks of vibrational modes as markers for specific types of exercises. We emphasize that the spectral wavenumbers identified by FTIR could serve as practical markers in distinguishing between different exercise modalities, with sensitivity, specificity, and accuracy correlating with the metabolic changes induced by exercise. Therefore, this study contributes a panel of ATR-FTIR spectral wavenumbers that can be referenced as a spectral signature capable of distinguishing between resistance and endurance exercises.

Cardioprotective Effects of the 4-Week Aerobic Running Exercises Before Treatment with Doxorubicin in Rats.

Doxorubicin is associated with cardiotoxicity, and physical exercise seeks to minimize the toxic effects of doxorubicin through physiological cardiac remodeling, as well as the reduction of oxidative stress, evidenced by previous studies. This study aimed to analyze whether running training before treatment with doxorubicin influences tolerance to physical exertion and cardiotoxicity. Thirty-nine male Wistar rats, aged 90 days and weighing between 250 and 300 g, were divided into 4 groups: Control (C), Doxorubicin (D), Trained (T), and Trained + Doxorubicin (TD). Animals in groups T and DT were submitted to treadmill running for 3 weeks, 5 times a week at 18 m/min for 20-30 min before treatment with doxorubicin. Animals in groups D and DT received intraperitoneal injections of doxorubicin hydrochloride three times a week for two weeks, reaching a total cumulative dose of 7.50 mg/kg. Our results show an increase in total collagen fibers in the D group (p = 0.01), but no increase in the TD group, in addition to the attenuation of the number of cardiac mast cells in the animals in the TD group (p = 0.05). The animals in the TD group showed maintenance of tolerance to exertion compared to group D. Therefore, running training attenuated the cardiac damage caused by the treatment with doxorubicin, in addition to maintaining the tolerance to exertion in the rats.