Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study
Artículo
Materias > Biomedicina
Materias > Educación física y el deporte
Universidad Europea del Atlántico > Investigación > Artículos y libros
Cerrado
Inglés
INTRODUCTION:
Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects.
METHODS:
PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful.
RESULTS:
Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases.
CONCLUSION:
This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC.
metadata
May, Anne; Hiensch, Anouk; Depenbusch, Johanna; Schmidt, Martina; Monninkhof, Evelyn; Peláez, Mireia; Clauss, Dorothea; Zimmer, Philipp; Belloso, Jon; Trevaskis, Mark; Rundqvist, Helene; Wiskemann, Joachim; Muller, Jana; Fremd, Carlo; Altena, Renske; Kufel-Grabowska, Joanna; Bijlsma, Rhode; van Leeuwen-Snoeks, Lobke; Bokkel-Huinink, Daan ten; Sonke, Gabe; Mann, Bruce; Francis, Prudence; Richardson, Gary; Álvarez, Isabel; Malter, Wolfram; Van der Wall, Elsken; Aaronson, Neil; Senkus, Elżbieta; Urriticoechea, Ander; Zopf, Eva; Bloch, Wilhelm; Stuiver, Martijn; Wengström, Yvonne y Steindorf, Karen
mail
SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, mireia.pelaez@uneatlantico.es, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR
(2024)
Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study.
Cancer Research, 84 (9_Supp).
GS02-10.
ISSN 1538-7445
Resumen
INTRODUCTION: Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects. METHODS: PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful. RESULTS: Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases. CONCLUSION: This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC.
| Tipo de Documento: | Artículo |
|---|---|
| Clasificación temática: | Materias > Biomedicina Materias > Educación física y el deporte |
| Divisiones: | Universidad Europea del Atlántico > Investigación > Artículos y libros |
| Depositado: | 18 Sep 2024 23:30 |
| Ultima Modificación: | 18 Sep 2024 23:30 |
| URI: | https://repositorio.uneatlantico.es/id/eprint/14247 |
Acciones (logins necesarios)
 |
Ver Objeto |
en
close
Background Post-kala-azar dermal leishmaniasis (PKDL) is a skin condition that can become a complication in about 15 % of patients who have had kala-azar. Despite its significance, treatment options for PKDL are still limited. This systematic review and meta-analysis aim to evaluate the efficacy of amphotericin B for this condition. Methods PubMed, Embase, Cochrane, and Web of Science databases were searched for randomized controlled trials (RCTs) that reported the efficacy of Liposomal Amphotericin B in the treatment of PKDL. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Events per 100 observations with 95 % confidence intervals were performed for outcomes. Results Nine studies with 639 patients were included, the treatment durations ranging from 7 to 60 days. The mean age ranged from 9.2 to 31.0 years, and 359 patients were male. The PKDL treatment with liposomal amphotericin B resulted in a cure rate of 91.36 % (95 % CI: 76.60-97.15). However, a relapse was observed in 11.42 % (95 % CI: 6.20-20.8) of patients. Adverse events were common, with hepatic enzyme elevation (ALT/AST) being the most frequent (61.75 %; 95 % CI: 21.81–90.33), followed by fever in 29.93 % of cases (95 % CI: 5.09–77.30). Among the more serious side effects, decreased serum potassium was observed in 19.27 % (95 % CI: 3.84–58.82), and increased serum creatinine, indicative of nephrotoxicity, occurred in 15.08 % (95 % CI: 3.97–43.27). Nausea or vomiting, although less severe, affected 12.36 % of patients (95 % CI: 4.81–28.25). Conclusions These findings highlight that while liposomal amphotericin B is a potent therapeutic option for PKDL, its administration requires careful management and clinical vigilance to optimize outcomes and minimize risks.
Deivyd Vieira Silva Cavalcante mail , Lilia Maria Lima de Oliveira mail , Noor Husain mail , Beatriz Ximenes Mendes mail , Ana Clara Felix de Farias Santos mail , Luciana Borrigueiro mail , Lyria de Oliveira Rosa mail , Christian Ndikuryayo mail , Sarah Soares Amorim mail , Lalit Mohan mail , Fabiana Castro Porto Silva Lopes mail ,
Cavalcante
en
close
Enzymatic treatment shapes in vitro digestion pattern of phenolic compounds in mulberry juice
The health benefits of mulberry fruit are closely associated with its phenolic compounds. However, the effects of enzymatic treatments on the digestion patterns of these compounds in mulberry juice remain largely unknown. This study investigated the impact of pectinase (PE), pectin lyase (PL), and cellulase (CE) on the release of phenolic compounds in whole mulberry juice. The digestion patterns were further evaluated using an in vitro simulated digestion model. The results revealed that PE significantly increased chlorogenic acid content by 77.8 %, PL enhanced cyanidin-3-O-glucoside by 20.5 %, and CE boosted quercetin by 44.5 %. Following in vitro digestion, the phenolic compound levels decreased differently depending on the treatment, while cyanidin-3-O-rutinoside content increased across all groups. In conclusion, the selected enzymes effectively promoted the release of phenolic compounds in mulberry juice. However, during gastrointestinal digestion, the degradation of phenolic compounds surpassed their enhanced release, with effects varying based on the compound's structure.
Peihuan Luo mail , Jian Ai mail , Qiongyao Wang mail , Yihang Lou mail , Zhiwei Liao mail , Francesca Giampieri mail francesca.giampieri@uneatlantico.es, Maurizio Battino mail maurizio.battino@uneatlantico.es, Elwira Sieniawska mail , Weibin Bai mail , Lingmin Tian mail ,
Luo
<a class="ep_document_link" href="/17819/1/1-s2.0-S2214804325000679-main%20%281%29.pdf"><img class="ep_doc_icon" alt="[img]" src="/style/images/fileicons/text.png" border="0"/></a>
en
open
What works in financial education? Experimental evidence on program impact
Financial education is increasingly essential for safeguarding both individual and corporate well-being. This study systematically reviews global financial education experiments using a dual-method framework that integrates a deep learning classifier with advanced multivariate statistical techniques. Our analysis indicates that while short-term improvements in financial literacy are common, such gains tend to diminish over time without ongoing reinforcement. Moreover, the limited impact of digital innovations and monetary incentives suggests that successful financial education depends on more than simply deploying technological solutions or extrinsic rewards. Overall, this review provides valuable insights into the evolving landscape of financial education in a dynamic economic context and underscores the need for sustainable strategies that secure lasting improvements in financial literacy.
Gonzalo Llamosas García mail , Cristina Mazas Pérez-Oleaga mail cristina.mazas@uneatlantico.es,
García
en
close
Epigallocatechin gallate (EGCG) is the most abundant polyphenol in tea. Owing to the different fermentation degrees, differences in polyphenol composition of water extracts of green tea, white tea, oolong tea, and black tea occur, and affect health value. This study revealed that the content of EGCG decreases with the increase in the degree of fermentation. In tea with a high fermentation degree, EGCG was stably present in the form of ammoniation to yield nitrogen-containing EGCG derivative (N-EGCG). The content of N-EGCG in tea was negatively correlated with the content of EGCG. Furthermore, the content of l-serine and L-threonine in tea was positively and negatively correlated with N-EGCG and EGCG levels, respectively, suggesting that they may participate in the formation of N-EGCG as nitrogen sources. This study proposes a new fermentation-induced polyphenol-amino acid synergistic mechanism, which provides a theoretical basis for the study of the biotransformation reaction mechanism of tea polyphenols.
Yuxuan Zhao mail , Jingyimei Liang mail , Wanning Ma mail , Mohamed A. Farag mail , Chunlin Li mail , Jianbo Xiao mail ,
Zhao
en
close
Single-cell omics for nutrition research: an emerging opportunity for human-centric investigations
Understanding how dietary compounds affect human health is challenged by their molecular complexity and cell-type–specific effects. Conventional multi-cell type (bulk) analyses obscure cellular heterogeneity, while animal and standard in vitro models often fail to replicate human physiology. Single-cell omics technologies—such as single-cell RNA sequencing, as well as single-cell–resolved proteomic and metabolomic approaches—enable high-resolution investigation of nutrient–cell interactions and reveal mechanisms at a single-cell resolution. When combined with advanced human-derived in vitro systems like organoids and organ-on-chip platforms, they support mechanistic studies in physiologically relevant contexts. This review outlines emerging applications of single-cell omics in nutrition research, emphasizing their potential to uncover cell-specific dietary responses, identify nutrient-sensitive pathways, and capture interindividual variability. It also discusses key challenges—including technical limitations, model selection, and institutional biases—and identifies strategic directions to facilitate broader adoption in the field. Collectively, single-cell omics offer a transformative framework to advance human-centric nutrition research.
Manuela Cassotta mail manucassotta@gmail.com, Yasmany Armas Diaz mail , Danila Cianciosi mail , Bei Yang mail , Zexiu Qi mail , Ge Chen mail , Santos Gracia Villar mail santos.gracia@uneatlantico.es, Luis Alonso Dzul López mail luis.dzul@uneatlantico.es, Giuseppe Grosso mail , José L. Quiles mail , Jianbo Xiao mail , Maurizio Battino mail maurizio.battino@uneatlantico.es, Francesca Giampieri mail francesca.giampieri@uneatlantico.es,
Cassotta