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Effects of a 12-week multicomponent exercise programme on physical function in older adults with cancer: Study protocol for the ONKO-FRAIL randomised controlled trial

Introduction Cancer in older adults is often associated with functional limitations, geriatric syndromes, poor self-rated health, vulnerability, and frailty, and these conditions might worsen treatment-related side effects. Recent guidelines for patients with cancer during and after treatment have documented the beneficial effects of exercise to counteract certain side effects; however, little is known about the role of exercise during cancer treatment in older adults. Materials and Methods This is a multicentre randomised controlled trial in which 200 participants will be allocated to a control group or an intervention group (the sample size has been calculated to detect a clinical difference of 1 point in Short Physical Performance Battery (SPPB) score, assuming an α error of 0.05, a β error of 0.20, and a 10 % loss rate). Patients aged ≥70 years, diagnosed with any type of solid cancer and candidates for systemic treatment are eligible. Subjects in the intervention group are invited to participate in a 12-week supervised multicomponent exercise programme in addition to receiving usual care. Study assessments are conducted at baseline and three months. The primary outcome measure is physical function as assessed by the SPPB. Secondary outcome measures include comprehensive geriatric assessment scores (including social situation, basic and instrumental activities of daily living, cognitive function, depression, nutritional status, polypharmacy, geriatric syndromes, pain, and emotional distress), anthropometric characteristics, frailty status, physical fitness, physical activity, cognitive function, quality of life, fatigue, and nutritional status. Study assessments also include analysis of inflammatory, endocrine, and nutritional mediators in serum and plasma as potential frailty biomarkers at mRNA and protein levels and multiparametric flow cytometric analysis to measure immunosenescence markers on T and NK cells. Discussion This study seeks to extend our knowledge on exercise interventions during systemic anticancer treatment in patients over 70 years of age. Results from this research will guide the management of older adults during systemic treatment in hospitals seeking to enhance the standard of care.

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Julia García-García mail , Ana Rodriguez-Larrad mail , Maren Martinez de Rituerto Zeberio mail , Jenifer Gómez Mediavilla mail , Borja López-San Vicente mail , Nuria Torrego Artola mail , Izaskun Zeberio Etxetxipia mail , Irati Garmendia mail , Ainhoa Alberro mail , David Otaegui mail , Francisco Borrego Rabasco mail , María M. Caffarel mail , Kalliopi Vrotsou mail , Jon Irazusta mail , Haritz Arrieta mail , Mireia Peláez mail mireia.pelaez@uneatlantico.es, Jon Belloso mail , Laura Basterretxea mail ,

García-García

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Effects of physical activity and diet in pregnancy to prevent gestational diabetes: an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation

Background Physical inactivity and suboptimal diet in pregnancy are important modifiable risk factors for gestational diabetes, a major contributor to pregnancy complications. Objectives We aimed to assess the effects of physical activity and/or diet-based lifestyle interventions during pregnancy on gestational diabetes and if these vary by maternal (body mass index, age, parity, ethnicity, education) and intervention characteristics using individual participant data meta-analysis of randomised trials, and a cost-effectiveness analysis. Data sources International Weight Management in Pregnancy Collaborative Network database was updated by searching major databases from February 2017 to March 2022. Review methods The main outcomes were gestational diabetes by any criteria and by the National Institute for Health and Care Excellence. Other outcomes were gestational diabetes as per International Association of Diabetes in Pregnancy Study Group and maternal and perinatal outcomes. We performed a two-stage random-effects individual participant data meta-analysis to obtain summary estimates (odds ratio) with 95% confidence intervals. Study quality of included trials was assessed, and heterogeneity summarised using τ2. Where possible, we added the aggregate data from non-individual participant data trials to the meta-analysis. We ranked interventions by effectiveness using network meta-analysis and undertook model-based economic evaluation to assess cost-effectiveness. The cost-effectiveness analysis took an NHS cost perspective compared an overall lifestyle intervention versus usual care with a time horizon covering the beginning of pregnancy until the discharge of the mother and infant from the hospital following delivery. Results Ninety-two trials (32,284 women) were included; 54 (23,698 women) provided individual participant data. Lifestyle interventions reduced the odds of gestational diabetes (any criteria) by 10% in individual participant data trials (odds ratio 0.90, 95% confidence interval 0.80 to 1.02, 54 studies, 23,361 women), and the findings reached statistical significance when non-individual participant data were included (odds ratio 0.81, 95% confidence interval 0.73 to 0.89, 92 studies, 31,947 women). Physical activity significantly reduced the odds of gestational diabetes by 36% (odds ratio 0.64; 95% confidence interval 0.48 to 0.84), and diet by 19% (odds ratio 0.81; 0.69 to 0.96), but not mixed interventions. Women with middle (odds ratio 0.68, 95% confidence interval 0.51 to 0.90) and high educational level (odds ratio 0.71, 95% confidence interval 0.54 to 0.93) benefited more than those with low educational status, and no differences by maternal body mass index, age, parity or ethnicity. There was no significant reduction in gestational diabetes defined by National Institute for Health and Care Excellence criteria (odds ratio 0.98, 95% confidence interval 0.84 to 1.13) in individual participant data trials. For gestational diabetes defined using International Association of Diabetes in Pregnancy Study Group criteria, interventions reduced gestational diabetes by 14% (odds ratio 0.86, 95% confidence interval 0.75 to 0.97, τ2 = 0.00, 16 studies, 6174 women) in individual participant data trials and by 17% (odds ratio 0.83, 95% confidence interval 0.72 to 0.95, τ2 = 0.01, 25 studies, 7883 women) when non-individual participant data trials were added. Overall, physical activity reduced caesarean section (odds ratio 0.83; 0.72 to 0.96), small-for-gestational age (odds ratio 0.72; 0.56 to 0.92) and large-for-gestational age babies (odds ratio 0.81; 0.71 to 0.94); diet-based interventions reduced any preterm birth (odds ratio 0.37; 0.20 to 0.68) compared to controls. No differences were observed for other outcomes. Lifestyle interventions were on average more expensive and more effective at averted gestational diabetes and major outcome averted compared to usual care. Limitations We could not identify the specific intervention components and delivery methods associated with improved outcomes, due to variations in reporting. Conclusion Lifestyle interventions in pregnancy prevent gestational diabetes, and the effects vary according to the definition of gestational diabetes. Physical activity-based interventions may be the most effective.

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John Allotey mail , Dyuti Coomar mail , Joie Ensor mail , Chidubem Okeke Ogwulu mail , Gabriel Ruiz Calvo mail , Mark Monahan mail , Valencia Kabeya mail , Rachel McNeill mail , Anna Boath mail , Ghadir Mahmoud mail , Cheryce Harrison mail , Mahnaz Bahri Khomami mail , Helena Teede mail , Nicola Heslehurst mail , Graham A Hitman mail , Sharon Anne Simpson mail , Krish Nirantharakumar mail , Julie Dodds mail , Kelly C Allison mail , Garry Shen mail , Elisabetta Petrella mail , Fabio Facchinetti mail , Christina Vinter mail , Mireia Peláez mail mireia.pelaez@uneatlantico.es, Dorte Møller Jensen mail , Narges Sadat Motahari-Tabari mail , Tarja I Kinnunen mail , Jonatan R Ruiz mail , Annick Bogaerts mail , Kristina Martha Renault mail , Alka Kothari mail , Jose Guilherme Cecatti mail , Fionnuala M McAuliffe mail , Suzanne Phelan mail , Lucilla Poston mail , Ana Pilar Betrán mail , Ngawai Moss mail , Stamatina Iliodromiti mail , Frances Austin mail , Nuria García de la Torre mail , Alfonso Luis Calle Pascual mail , Javier Zamora mail , Tracy Roberts mail , Richard D Riley mail , Shakila Thangaratinam mail ,

Allotey

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Real‐world effectiveness of integrating clinical psychologists into primary care: First‐year outcomes from a regional programme for common mental disorders in Spain

Objectives Common mental disorders (CMDs), including depression and anxiety, are highly prevalent in primary care, yet access to psychological therapies, which are the first-line treatment for these conditions, remains limited. This study evaluated the effectiveness of the Clinical Psychology in Primary Care Programme in Cantabria during its first year of implementation, which integrated clinical psychologists into primary care teams to deliver brief, evidence-based interventions. Design Naturalistic observational pre–post study in primary care. Methods A total of 1149 patients (66% women; M = 44 years) were assessed with the PHQ-9 and GAD-7 before and after a brief psychological intervention of up to eight sessions per patient delivered individually or in groups. Linear mixed-effects models examined pre–post changes and moderators (intervention format, age, sex). Reliable change, deterioration and recovery were calculated. Results Significant and clinically meaningful reductions were observed in depressive (ΔPHQ-9 = −7.8) and anxiety symptoms (ΔGAD-7 = −7.1; p < .001). Individual therapy produced greater improvements than group interventions, and younger participants showed slightly larger gains; sex showed no effect. Moderate variability in outcomes was observed across therapists. Among completers, large effect sizes were found (dRM ≈ 1.3); 73% achieved reliable improvement and 51% met reliable recovery criteria, while deterioration rates were below 1%. Conclusions Findings support the consolidation and expansion of the integration of clinical psychologists into primary care, providing evidence that the psychological interventions delivered in this context are a feasible, equitable and effective approach to treating CMDs in the Spanish public health system.

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César González‐Blanch mail cesar.gonzalezblanch@uneatlantico.es, Noelia Rodríguez‐Pérez mail , María Camino‐Sánchez mail , Rosario Bengochea-Seco mail , Cintia Montes‐Novoa mail , David Gil-Sanz mail david.gil@uneatlantico.es, Silvia Pérez‐Monzón mail , Blanca Uriz‐Zafra mail , Mikel Muñiz‐Videchea mail , Paula Díaz‐Gómez mail , Amador Priede mail ,

González‐Blanch

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Liquorice alters adipocyte–breast cancer cell crosstalk by modulating oxidative stress and suppressing aromatase and renin–angiotensin signalling

Obesity is recognised to be a risk factor for breast cancer since adipose tissue influences the tumour microenvironment. This study aims to investigate the effect of the secretome of 3T3-L1 adipocytes untreated or treated with liquorice root extract (LRE), containing flavonoids, phenolic acids, and saponins on MCF-7 breast cancer cells. By treating adipocytes with LRE, the secretion of certain pro-tumorigenic factors like IGFBP-6, resistin, and VEGF was reduced. MCF-7 cells exposed to conditioned medium from LRE-treated adipocytes exhibited an increase in reactive oxygen species levels, downregulation of the Nrf2 antioxidant pathway, and increased autophagy. Those conditions reduced cell viability, migration, and colony formation. Additionally, there was downregulation of genes associated with oestrogen signalling and tumour-related processes, including CYP19A1 (aromatase), ERα, Her2, and components of the renin–angiotensin system (RAS). These findings suggest that LRE can modulate the adipocyte secretome to influence breast cancer cell behaviour under obesity-related in vitro conditions.

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Danila Cianciosi mail , Yasmany Armas Diaz mail , Bei Yang mail , Zexiu Qi mail , Ge Chen mail , José L. Quiles mail jose.quiles@uneatlantico.es, Massimiliano Gasparrini mail , Manuela Cassotta mail manucassotta@gmail.com, Rubén Calderón Iglesias mail ruben.calderon@uneatlantico.es, Maurizio Battino mail maurizio.battino@uneatlantico.es, Francesca Giampieri mail francesca.giampieri@uneatlantico.es,

Cianciosi

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A novel approach for disease and pests detection in potato production system based on deep learning

Vulnerability of potato crops to diseases and pest infestation can affect its quality and lead to significant yield losses. Timely detection of such diseases can help take effective decisions. For this purpose, a deep learning-based object detection framework is designed in this study to identify and classify major potato diseases and pests under real-world field conditions. A total of 2,688 field images were collected from two research farms in Punjab, Pakistan, across multiple growth stages in various seasonal conditions. Excluding 285 symptoms-free images from the earliest collection led to 2,403 images which were annotated into four biotic-stress classes: blight disease (n = 630), leaf spot disease (n = 370), leafroll virus (viral symptom complex; n = 888), and Colorado potato beetle (larvae/adults; n = 515), indicating class imbalance. Several state-of-the-art models were used including YOLOv8 variants (n/s/m), YOLOv7, YOLOv5, and Faster R-CNN, and the results are discussed in relation to recent potato disease classification studies involving cropped leaf images. Stratified splitting (70% training, 20% validation, 10% testing) was applied to preserve class distribution across all subsets. YOLOv8-medium achieve the best performance with mean average precision (mAP)@0.5 of 98% on the held-out test images. Results for stable 5-fold cross-validation show a mean mAP@0.5 of 97.8%, which offers a balance between accuracy and inference time. Model robustness was evaluated using 5-fold cross-validation and repeated training with different random seeds, showing a low variance of ±0.4% mAP. Results demonstrate promising outcomes under the real-world field conditions, while, broader cross-region and cross-season validation is intended for the future.

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Ahmed Abbas mail , Saif Ur Rehman mail , Khalid Mahmood mail , Santos Gracia Villar mail santos.gracia@uneatlantico.es, Luis Alonso Dzul López mail luis.dzul@uneatlantico.es, Aseel Smerat mail , Imran Ashraf mail ,

Abbas