A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial.

PURPOSE: To investigate the efficacy of a novel, multi-active emollient in preventing and managing acute radiation dermatitis (ARD) in breast cancer patients undergoing moderate hypofractionated (HF) radiotherapy (RT) compared to standard of care. METHODSA: A monocentric, open-label, randomized clinical trial (RCT) with breast cancer patients receiving moderate HF (dose: 40.05-55.86 Gy, fractions: 15-21) was conducted between January 2022 and May 2023. The experimental group received the novel emollient, while the control group received the standard skin care. Patients applied the skin care products twice daily during the complete RT course. The primary outcome was the severity of ARD at the final RT session measured by the modified Radiation Therapy Oncology Group (RTOG) criteria. Secondary outcomes included patient symptoms, quality of life (QoL), and treatment satisfaction. RESULTS: A total of 100 patients with 50 patients per group were enrolled. In the control group, 50% of the patients developed RTOG grade 1 ARD and 48% grade 2 or higher, while in the experimental group, the severity of ARD was significantly lower with 82% grade 1 and 16% grade 2 ARD (P = .013, χ2-test). The frequency and severity of xerosis were significantly lower in the experimental compared to the control group (Ps ≤ .036, Mann Whiney U test). The impact of ARD on the QoL was low, and treatment satisfaction was high in both groups, with no significant difference. CONCLUSION: This RCT shows that the novel, multi-active emollient significantly reduced the ARD RTOG grade. Research in a more diverse patient population is warranted. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04929808 (11/06/2021).

Incidence and risk factors for adverse events during monitored anaesthesia care for gastrointestinal endoscopy in children: A prospective observational study.

BACKGROUND: Better understanding of risk factors for adverse events during monitored anaesthesia care (MAC) for paediatric gastrointestinal endoscopy may improve outcome in children. OBJECTIVES: To identify the prevalence and predictors of adverse events during MAC for paediatric endoscopy. DESIGN: An observational study. SETTING: Tertiary university hospital, single-centre cohort, from January 2010 to August 2016. PATIENTS: The prospectively collected electronic anaesthetic records of 3435 children aged up to 16 years who underwent diagnostic gastrointestinal endoscopy under MAC were analysed retrospectively. Children with an American Society of Anesthesiologists' physical status at least 4, and those requiring mechanical ventilation and therapeutic or urgent endoscopy were excluded. MAIN OUTCOME MEASURES: The prevalence and predictors of adverse events during MAC for paediatric gastrointestinal endoscopy, with particular reference to the use of different anaesthetic or sedative agents. RESULTS: Mean ±â€ŠSD age of the children was 8.5 ±â€Š4.4 years. The incidences of adverse events and adverse respiratory events were 3.4 and 3.3%, respectively. Multivariate analysis identified 12 independent predictors: age [odds ratio (OR) 0.92, P = 0.002], children's size for example underweight (OR 1.78, P = 0.039), overweight (OR 2.20, P = 0.039), (morbid) obesity (OR 4.25, P = 0.006), presence of respiratory comorbidities (OR 8.18, P < 0.001), recent respiratory infection (OR 23.55, P < 0.001) or both (OR 17.46, P < 0.001), neurological comorbidities (OR 2.18, P = 0.007), upper gastrointestinal endoscopy (OR 5.66, P < 0.001), propofol co-administration with ketamine (OR 10.34, P < 0. 001) or after sevoflurane induction (OR 44.95, P < 0.001), and propofol induction dose (OR 18.97, P < 0.001). Posthoc secondary analyses revealed a significantly higher risk of adverse events (OR 3.9, P < 0.0001) and also significantly more respiratory comorbidities and respiratory infections (P < 0.0001) in children aged less than 2 years when compared with children aged at least 2 years. No cardiovascular events were observed and outcome was uneventful. CONCLUSION: The present cohort demonstrated the feasibility and safety of MAC for paediatric gastrointestinal endoscopy by an experienced team. Although adverse events occurred rarely, their predictive factors were clinically identifiable. Applying this information in risk assessment and modifying anaesthetic management accordingly could improve outcome. TRIAL REGISTRATION: ISRCTN70362666.

Treatment of unresectable stage III NSCLC: Real world cohort study and literature review.

INTRODUCTION: Until recently, the treatment for patients with locally advanced unresectable stage III non-small cell lung cancer (NSCLC) was combined chemoradiotherapy (CRT), delivered either concurrently (cCRT) or sequentially (sCRT). There is limited data on the outcomes and safety of CRT in a real-world setting. We conducted a real-world cohort analysis of our Leuven Lung Cancer Group (LLCG) experience with CRT for unresectable stage III NSCLC, prior to the era of consolidation treatment with immunotherapy. PATIENTS AND METHODS: In this observational, real-world monocentric cohort study, a total of 163 consecutive patients were included. They were diagnosed with unresectable stage III primary NSCLC and treated with CRT between January 1st, 2011, and December 31st, 2018. Patient and tumor characteristics, treatment patterns, toxicity, and primary outcome parameters such as PFS, OS and pattern of relapse were captured. RESULTS: CRT was concurrent in 108 patients, sequential in 55. Overall tolerability was good, with two thirds of patients without severe adverse events such as severe febrile neutropenia, ≥ grade 2 pneumonitis, or ≥ grade 3 esophagitis. All registered adverse events were more frequent in the cCRT group compared to the sCRT group. Median PFS was 13.2 months (95% CI 10.3-16.2), median OS was 23.3 months (95% CI 18.3-28.0), with a 47.5% survival rate at 2 years, and 29.4% at five years. CONCLUSIONS: This study provides a clinically relevant benchmark on the outcomes and toxicity of concurrent and sequential chemoradiotherapy in unresectable stage III NSCLC in a real-world setting in the pre-PACIFIC era.

Long-term effects of orthodontic interceptive expansion treatment : A retrospective study.

PURPOSE: The aim of this retrospective cohort study was to evaluate the long-term effects of interceptive orthodontic treatment with a removable expansion plate, based on transversal, sagittal, and vertical parameters. METHODS: A total of 90 patients needing interceptive treatment due to a crossbite or space deficiency were included. Records consisting of clinical photos, radiographs, and digital dental casts were collected for evaluation at two time points: the start of interceptive treatment (T0) and the start of comprehensive treatment (T1). Molar occlusion, overjet, overbite, presence and type of crossbite, mandibular shift, and transversal measurements were recorded for comparison. RESULTS: After expansion with removable appliances, a significant increase in intermolar width was achieved and could be maintained over the observation period (p < 0.001). However, no significant changes regarding overjet, overbite, or molar sagittal occlusion were observed. Crossbite correction was successful in 86.9% of patients with unilateral crossbite and in 75.0% of patients with bilateral crossbite (p < 0.001). CONCLUSION: Early expansion with a removable expansion plate is a successful method to correct crossbites and increase intermolar width in the early mixed dentition phase. Results remain stable until the start of comprehensive treatment in the permanent dentition.

Potential risks of hemolysis after short-term administration of analgesics in children with glucose-6-phosphate dehydrogenase deficiency.

OBJECTIVE: To evaluate the risk of hemolysis in children with glucose-6-phosphate dehydrogenase (G6PD) deficiency after short-term administration of analgesics, such as paracetamol, ibuprofen, tramadol, sufentanil, and parecoxib. STUDY DESIGN: This was a prospective study of children with G6PD deficiency who were treated with analgesics for 3 days after undergoing surgery. Hemoglobin (Hb) concentration, reticulocyte count, unconjugated bilirubin level, lactate dehydrogenase level, and the presence of Heinz bodies on blood smear microscopy were assessed at baseline and after analgesic treatment. Telephone interviews and clinical reviews were provided during a 7-day study period. The primary outcome was evidence of hemolysis. Statistical analyses were done using the paired Student t test or Wilcoxon signed-rank test as appropriate. RESULTS: Ten male infants (mean age, 4.3 ± 1.3 years) completed the study. The mean decrease in (Hb) concentration was -0.2 g/dL (P, not significant). The mean reticulocyte count increased by 0.1% (95% CI, 0.08%-0.2%; P = .001). However, the change in reticulocyte count was not correlated with the changes in Hb concentration or other laboratory results and was not accompanied by the clinical signs and symptoms of hemolysis. CONCLUSION: Short-term administration of paracetamol, ibuprofen, tramadol, sufentanil, and parecoxib in therapeutic dosages did not increase the risk of hemolysis in children with G6PD deficiency.