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A phase Ib/II study of eribulin in combination with cyclophosphamide in patients with advanced breast cancer.
Gumusay, O, Huppert, LA, Magbanua, MJM, Wabl, CA, Assefa, M, Chien, AJ, Melisko, ME, Majure, MC, Moasser, M, Park, J, et al
Breast cancer research and treatment. 2024;(2):197-204
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Abstract
PURPOSE We hypothesized that eribulin combined with cyclophosphamide (EC) would be an effective combination with tolerable toxicity for the treatment of advanced breast cancer (ABC). METHODS Patients with histologically confirmed metastatic or unresectable ABC with any number of prior lines of therapy were eligible to enroll. In the dose escalation cohort, dose level 0 was defined as eribulin 1.1 mg/m2 and cyclophosphamide 600 mg/m2, and dose level 1 was defined as eribulin 1.4 mg/m2 and cyclophosphamide 600 mg/m2. Eribulin was given on days 1 and 8 and cyclophosphamide on day 1 of a 21-day cycle. In the dose expansion cohort, enrollment was expanded at dose level 1. The primary objective was clinical benefit rate (CBR), and secondary objectives were response rate (RR), duration of response (DOR), progression-free survival (PFS), and safety. RESULTS No dose-limiting toxicities were identified in the dose escalation cohort (n = 6). In the dose expansion cohort, an additional 38 patients were enrolled for a total of 44 patients, including 31 patients (70.4%) with hormone receptor-positive (HR +)/HER2- disease, 12 patients (27.3%) with triple-negative breast cancer (TNBC), and 1 patient (2.3%) with HR + /HER2 + disease. Patients had a median age of 56 years (range 33-82 years), 1 prior line of hormone therapy (range 0-6), and 2 prior lines of chemotherapy (range 0-7). CBR was 79.5% (35/44; 7 partial response, 28 stable disease) and the median DOR was 16.4 weeks (range 13.8-21.1 weeks). Median PFS was 16.4 weeks (95% CI: 13.8-21.1 weeks). The most common grade 3/4 adverse event was neutropenia (47.7%, n = 21). Fourteen of 26 patients (53.8%) with circulating tumor cell (CTC) data were CTC-positive ([Formula: see text] 5 CTC/7.5 mL) at baseline. Median PFS was shorter in patients who were CTC-positive vs. negative (13.1 vs 30.6 weeks, p = 0.011). CONCLUSION In heavily pretreated patients with ABC, treatment with EC resulted in an encouraging CBR of 79.5% and PFS of 16.4 weeks, which compares favorably to single-agent eribulin. Dose reduction and delays were primarily due to neutropenia. The contribution of cyclophosphamide to eribulin remains unclear but warrants further evaluation. NCT01554371.
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Effect of Fluid and Caffeine Management on Quality of Life in Older Women with Overactive Bladder in Rural Korea: A Pilot Study.
Park, J, Lee, K, Lee, K
Journal of multidisciplinary healthcare. 2024;:1549-1559
Abstract
PURPOSE This study aimed to investigate the effectiveness of the simplified intervention, consisting of fluid and caffeine management alone in older women with overactive bladder symptoms. PATIENTS AND METHODS A quasi-experimental pretest-posttest design was used. Rural, community-dwelling older women were recruited at four senior centers in South Korea. Of the 63 participants initially enrolled, 34 met the inclusion criteria. One group (n = 15) used fluid and caffeine management alone (FM), and the other group (n = 12) used a combination of fluid and caffeine management and pelvic floor muscle training (FM+PFMT). Urinary symptom-specific health-related quality of life was measured using the Korean version of KHQ. Sleep quality was measured using the Pittsburgh Sleep Quality Index. After the intervention, participants were assessed 4 and 8 weeks. A linear mixed model was used for the analysis. RESULTS The mean age of the participants was 74.44 ± 5.67 years. Among the nine domains of KHQ, impact on life and physical limitations decreased significantly in both groups, without significant between-group differences. Sleep/energy increased in both groups, and the scores in the FM+PFMT group were significantly improved. The number of micturition episodes per day and the quality of sleep did not differ significantly between the two groups. CONCLUSION A simplified intervention, consisting of fluid and caffeine management alone can be considered as the first-line intervention to improve health-related quality of life in rural, community-dwelling, older women with overactive bladder symptoms. Healthcare providers should consider providing a relatively simple, but equally effective intervention to maximize the adherence and effectiveness.
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The Coronavirus Anxiety Scale: Cross-national measurement invariance and convergent validity evidence.
Jovanović, V, Rudnev, M, Abdelrahman, M, Abdul Kadir, NB, Adebayo, DF, Akaliyski, P, Alaseel, R, Alkamali, YA, Alonso Palacio, LM, Amin, A, et al
Psychological assessment. 2024;(1):14-29
Abstract
Coronavirus Anxiety Scale (CAS) is a widely used measure that captures somatic symptoms of coronavirus-related anxiety. In a large-scale collaboration spanning 60 countries (Ntotal = 21,513), we examined the CAS's measurement invariance and assessed the convergent validity of CAS scores in relation to the fear of COVID-19 (FCV-19S) and the satisfaction with life (SWLS-3) scales. We utilized both conventional exact invariance tests and alignment procedures, with results revealing that the single-factor model fit the data well in almost all countries. Partial scalar invariance was supported in a subset of 56 countries. To ensure the robustness of results, given the unbalanced samples, we employed resampling techniques both with and without replacement and found the results were more stable in larger samples. The alignment procedure demonstrated a high degree of measurement invariance with 9% of the parameters exhibiting noninvariance. We also conducted simulations of alignment using the parameters estimated in the current model. Findings demonstrated reliability of the means but indicated challenges in estimating the latent variances. Strong positive correlations between CAS and FCV-19S estimated with all three different approaches were found in most countries. Correlations of CAS and SWLS-3 were weak and negative but significantly differed from zero in several countries. Overall, the study provided support for the measurement invariance of the CAS and offered evidence of its convergent validity while also highlighting issues with variance estimation. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Effects of energy loads on energy and nutrient absorption rates and gut microbiome in humans: A randomized crossover trial.
Yoshimura, E, Hamada, Y, Hatamoto, Y, Nakagata, T, Nanri, H, Nakayama, Y, Hayashi, T, Suzuki, I, Ando, T, Ishikawa-Takata, K, et al
Obesity (Silver Spring, Md.). 2024;(2):262-272
Abstract
OBJECTIVE This study aimed to determine the effects of different energy loads on the gut microbiota composition and the rates of energy and nutrient excretion via feces and urine. METHODS A randomized crossover dietary intervention study was conducted with three dietary conditions: overfeeding (OF), control (CON), and underfeeding (UF). Ten healthy men were subjected to each condition for 8 days (4 days and 3 nights in nonlaboratory and laboratory settings each). The effects of dietary conditions on energy excretion rates via feces and urine were assessed using a bomb calorimeter. RESULTS Short-term energy loads dynamically altered the gut microbiota at the α-diversity (Shannon index), phylum, and genus levels (p < 0.05). Energy excretion rates via urine and urine plus feces decreased under OF more than under CON (urine -0.7%; p < 0.001, urine plus feces -1.9%; p = 0.049) and UF (urine -1.0%; p < 0.001, urine plus feces -2.1%; p = 0.031). However, energy excretion rates via feces did not differ between conditions. CONCLUSIONS Although short-term overfeeding dynamically altered the gut microbiota composition, the energy excretion rate via feces was unaffected. Energy excretion rates via urine and urine plus feces were lower under OF than under CON and UF conditions.
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Frailty of Prostate Cancer Patients Receiving Androgen Deprivation Therapy: A Scoping Review.
Park, J, Ryu, GW, Lee, H, Choi, YD, Kim, Y
The world journal of men's health. 2024;(2):347-362
Abstract
PURPOSE This study aimed to explore the existing literature on frailty experienced by patients with prostate cancer (PC) receiving androgen deprivation therapy (ADT). MATERIALS AND METHODS Database and manual searches were conducted to identify relevant studies published in English, with no limitation on the year of publication, according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. Four databases-PubMed, Cochrane Library, EMBASE, and CINAHL-were used for database searches and reference lists, related journals, and Google Scholar were used for manual searches. RESULTS A total of 12 studies were analyzed for this scoping review. Of these, only 2 were intervention studies, and 1 was a randomized controlled trial. Among the two intervention studies, the multidisciplinary intervention program, including psychological counseling, nutritional coaching, and supervised group physical exercise did not show significant improvement in frailty. In contrast, high-dose vitamin D supplementation significantly decreased frailty. The conceptual and operational definitions of frailty used in each study varied, and the most used one was mainly focused on physical functions. As a result of analyzing the other health-related variables associated with frailty in patients with PC receiving ADT, age, metastases, comorbidities, and incident falls were related to a high frailty level. As for the physiological index, high levels of C-reactive protein, and interleukin-6, and fibrinogen, low levels of total testosterone, lymphocyte count, and creatinine were associated with a high level of frailty. A few studies explored the relationship between psychological and cognitive variables and frailty. CONCLUSIONS Further research related to frailty in patients with PC receiving ADT should be conducted, and effective interventions to manage frailty should be developed. Additionally, research that considers not only the physical domain of frailty but also the psychological, cognitive, and social domains needs to be conducted.
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Effectiveness of a Nurse-Led Mobile-Based Health Coaching Program for Patients With Prostate Cancer at High Risk of Metabolic Syndrome: Randomized Waitlist Controlled Trial.
Lee, K, Park, J, Oh, EG, Lee, J, Park, C, Choi, YD
JMIR mHealth and uHealth. 2024;:e47102
Abstract
BACKGROUND Androgen deprivation therapy (ADT), a standard treatment for prostate cancer (PC), causes many physical side effects. In particular, it causes metabolic changes such as fasting glucose abnormalities or accumulation of body fat, and its continuation can lead to metabolic syndrome (MetS), which is closely related to diabetes and cardiovascular disease. Therefore, it is important to maintain and practice a healthy lifestyle in patients with PC. OBJECTIVE This study aims to evaluate the effectiveness of a nurse-led mobile-based program that aims to promote a healthy lifestyle in patients with PC undergoing ADT with MetS risk factors. METHODS This was a single-blind, randomized, waitlist control interventional study. A total of 48 patients were randomly assigned to the experimental and waitlist control groups at the urology cancer clinic of a tertiary general hospital in South Korea. The inclusion criteria were patients who had undergone ADT for >6 months, had at least 1 of the 5 MetS components in the abnormal range, and could access a mobile-based education program. The experimental group attended a 4-week mobile-based program on exercise and diet that included counseling and encouragement to maintain a healthy lifestyle, whereas the control group was placed on a waitlist and received usual care during the follow-up period, followed by the intervention. The primary outcome was a change in the lifestyle score. The secondary outcomes were changes in 5 MetS components, body composition, and health-related quality of life. The outcomes were measured at 6 weeks and 12 weeks after the initiation of the intervention. Each participant was assigned to each group in a sequential order of enrollment in a 4×4 permuted block design randomization table generated in the SAS (SAS Institute) statistical program. A linear mixed model was used for statistical analysis. RESULTS A total of 24 participants were randomly assigned to each group; however, 2 participants in the experimental group dropped out for personal reasons before starting the intervention. Finally, 46 participants were included in the intention-to-treat analysis. The experimental group showed more positive changes in the healthy lifestyle score (β=29.23; P≤.001), level of each MetS component (fasting blood sugar: β=-12.0; P=.05 and abdominal circumference: β=-2.49; P=.049), body composition (body weight: β=-1.52; P<.001 and BMI: β=-0.55; P<.001), and the urinary irritative and obstructive domain of health-related quality of life (β=14.63; P<.001) over time than the waitlist control group. CONCLUSIONS Lifestyle changes through nurse-led education can improve level of each MetS components, body composition, and ADT side effects. Nurses can induce positive changes in patients' lifestyles and improve the self-management of patients starting ADT through this program. TRIAL REGISTRATION Clinical Research Information Service KCT0006560; http://tinyurl.com/yhvj4vwh.
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Comparative effects of glucose-lowering agents on endothelial function and arterial stiffness in patients with type 2 diabetes: A network meta-analysis.
Kim, H, Choi, CU, Rhew, K, Park, J, Lim, Y, Kim, MG, Kim, K
Atherosclerosis. 2024;:117490
Abstract
BACKGROUND AND AIMS Despite accumulating evidence on the potential of glucose-lowering agents (GLAs) to prevent cardiovascular events, the comparative effects of GLAs on vascular function remain unclear. This study utilized validated indicators such as flow-mediated dilation (FMD; positive value favors) and pulse wave velocity (PWV; negative value favors) to uncover the comparative effects of GLAs on vascular function. METHODS Randomized controlled trials (RCTs) comparing the effects of GLAs on FMD or PWV with placebo or other GLAs in patients with type 2 diabetes (T2DM) were searched through PubMed and Embase. The frequentist method of network meta-analysis (NMA) was conducted using a random effects model, and standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated. RESULTS The NMA included 38 RCTs with 2,065 patients. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium glucose cotransporter-2 inhibitors (SGLT-2Is) had significantly more positive effects on FMD improvement and PWV reduction than placebo. Thiazolidinedione (TZD) treatment resulted in significantly improved FMD compared to other GLAs as well as placebo (SMD: 1.14; 95% CI: 0.84 to 1.43). Both pioglitazone and rosiglitazone were discovered to have considerably more favorable effects on improving FMD and reducing PWV compared to placebo and other GLAs, as a result of the analysis incorporating each drug in the TZD class. The sensitivity analysis results corroborated the main findings. CONCLUSIONS This NMA showed more favorable effects of GLP-1RAs and SGLT-2Is than placebo in improving both arterial stiffness and endothelial function in patients with T2DM. In addition, TZDs showed superior effects in improving endothelial function as compared with the other GLAs and placebo.
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Superior Mesenteric Artery Syndrome in Anorexia Nervosa: A Case Report and a Systematic Revision of the Literature.
Bozzola, E, Irrera, M, Cirillo, F, Zanna, V, Petrelli, I, Diamanti, A, Scire, Y, Park, J, Marchesi, A, Marchili, MR, et al
Nutrients. 2024;(4)
Abstract
BACKGROUND Superior mesenteric artery syndrome (SMAS) is a rare condition caused by the compression of the duodenum, which may occur in the case of fast weight loss. Currently, the relationship between superior mesenteric artery syndrome and anorexia nervosa is still unclear. The aim of this study is to identify the precocious clinical signs and symptoms of SMAS in patients affected by anorexia nervosa so as not to delay the diagnosis. METHODS We present the clinical case of a young female patient with anorexia nervosa complicated by SMAS. We performed a literature review of SMAS in children affected by anorexia nervosa between 1962 and 2023, according to the PRISMA Extension Guide for Scoping Reviews. RESULTS Reviewing the literature, 11 clinical cases were described for the pediatric age. The median age at diagnosis was 17 years (ranging from 13 to 18 years). The diagnosis of SMAS may be challenging as symptoms overlap those of anorexia, but it should be kept in mind mostly in cases of post-prandial abdominal pain, anxiety or depression, nausea, vomiting, and weight loss. CONCLUSION Even specific clinical symptoms may act as flag tags to drive attention to this rare but potentially fatal condition.
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Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus.
Lee, K, Lee, SK, Lee, J, Jeon, BK, Kim, TH, Yu, HT, Lee, JM, Park, JK, Baek, YS, Kim, DH, et al
PloS one. 2023;(1):e0280359
Abstract
SGLT-2 inhibitor, traditionally used for glycemic control, has several beneficial effects that can help manage heart failure (HF). SGLT-2 inhibitors reduce the risk of cardiovascular mortality in patients with HF. As atrial fibrillation (AF) is closely associated with HF and diabetes mellitus (DM) is a risk factor for AF, we assume that SGLT-2 inhibitors will also show therapeutic benefits regarding AF, especially for rhythm control. This trial has a multicenter, prospective, open, blinded endpoint design. It is a 1:1 randomized and controlled study. A total of 716 patients who are newly diagnosed of AF and DM within 1 year will be enrolled from 7 tertiary medical centers. The trial is designed to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents on atrial rhythm control in patients with AF and DM. The primary outcome is the recurrence of AF within a year (including post-antiarrhythmic drugs (AAD) or ablation). The secondary outcomes are the ablation rate within a year, change in AF burden, size of the left atrium, NT-proBNP, the AF symptom score, and the quality of life. This trial will prospectively evaluate the effect and safety of SGLT-2 inhibitors on AF rhythm control in patients with DM. It will provide an invaluable dataset on rhythm control in AF with DM for future studies and offer novel information to assist in clinical decisions. (BEYOND trial, ClinicalTrials.gov number: NCT05029115. https://clinicaltrials.gov/ct2/show/NCT05029115).
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Protein-Added Healthy Lunch-Boxes Combined with Exercise for Improving Physical Fitness and Vascular Function in Pre-Frail Older Women: A Community-Based Randomized Controlled Trial.
Park, W, Lee, J, Hong, K, Park, HY, Park, S, Kim, N, Park, J
Clinical interventions in aging. 2023;:13-27
Abstract
PURPOSE Preventive or therapeutic interventions are key to maintaining independence in pre-frail and/or frail elderly. Therefore, we investigated whether multi-component interventions were effective in physical fitness levels and vascular functions in pre-frail older women. PATIENTS AND METHODS Sixty participants aged ≥ 65 years (81.5 ± 4.3 yrs) were divided equally into control group, diet group, aerobic exercise and diet group, and aerobic exercise with electromyostimulation and diet group. For 8 weeks, the participants received a set of protein-added meals twice daily on weekdays. The aerobic exercise groups performed 45 mins of stepping exercise at 50-70% of the maximal heart rate for 3 days/week, and the aerobic exercise with electromyostimulation was applied on each limb in 8 weeks. Blood pressure, physical fitness, cardiovascular biomarkers, pulse wave velocity, and flow-mediated dilation were measured before and after the 8-week. RESULTS There were no group differences in age, height, weight, body mass index, free fat mass, and %body fat at baseline. The right grip strength significantly increased in the diet group, aerobic exercise and diet group, and aerobic exercise with electromyostimulation and diet group (p < 0.05). Short physical performance battery, 6-min walking distance, and flow-mediated dilation significantly increased in the aerobic exercise and diet group and aerobic exercise with electromyostimulation and diet group (p < 0.05). Blood pressure and pulse wave velocity did not differ between interventions. High-density lipoprotein-cholesterol levels significantly increased after 8 weeks in all intervention groups (p < 0.05). There were no significant differences in glucose, HbA1c, total cholesterol, low-density lipoprotein-cholesterol, triglyceride, insulin, Homeostatic Model Assessment for Insulin Resistance, nitric oxide, and C-reactive protein levels. CONCLUSION These results show that multi-component interventions appear to improve physical fitness and vascular function in pre-frail older women. Thus, possible strategies to prevent early frailty including proper nutrition and exercise may be needed.