| 51. |
- Müssener, Ulrika, et al.
(författare)
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Development of an Intervention Targeting Multiple Health Behaviors Among High School Students: Participatory Design Study Using Heuristic Evaluation and Usability Testing
- 2020
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Ingår i: JMIR mhealth and uhealth. - : JMIR PUBLICATIONS, INC. - 2291-5222. ; 8:10
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Tidskriftsartikel (refereegranskat)abstract
- Background: Mobile electronic platforms provide exciting possibilities for health behavior promotion. For instance, they can promote smoking cessation, moderate alcohol consumption, healthy eating, and physical activity. Young adults in Sweden are proficient in the use of technology, having been exposed to computers, smartphones, and the internet from an early age. However, with the high availability of mobile health (mHealth) interventions of varying quality, it is critical to optimize the usability of mHealth interventions to ensure long-term use of these health promotion interventions. Objective: This study aims to investigate the usability of an mHealth intervention (LIFE4YOUth) targeting health behaviors among high school students through heuristic evaluation and usability testing. Methods: A preliminary version of the LIFE4YOUth mHealth intervention, which was aimed at promoting healthy eating, physical activity, smoking cessation, and nonrisky drinking among high school students, was developed in early 2019. We completed a total of 15 heuristic evaluations and 5 usability tests to evaluate the usability of the mHealth intervention prototype to improve its functioning, content, and design. Results: Heuristic evaluation from a total of 15 experts (10 employees and 5 university students, both women and men, aged 18-25 years) revealed that the major usability problems and the worst ratings, a total of 17 problems termed usability catastrophes, concerned shortcomings in displaying easy-to-understand information to the users or technical errors. The results of the usability testing including 5 high school students (both girls and boys, aged 15-18 years) showed that the design, quality, and quantity of content in the intervention may impact the users level of engagement. Poor functionality was considered a major barrier to usability. Of the 5 participants, one rated the LIFE4YOUth intervention as poor, 2 rated as average, and 2 assessed it as good, according to the System Usability Scale. Conclusions: High school students have high expectations of digital products. If an mHealth intervention does not offer optimal functions, they may cease to use it. Optimizing the usability of mHealth interventions is a critical step in the development process. Heuristic evaluation and usability testing in this study provided valuable knowledge about the prototype from a users perspective. The findings may lead to the development of similar interventions targeting the high school population.
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| 52. |
- Rosell, Magdalena, et al.
(författare)
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Generation Pep Study: A population‐based survey on diet and physical activity in 12,000 Swedish children and adolescents
- 2021
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Ingår i: Acta Paediatrica. - : Wiley. - 0803-5253 .- 1651-2227. ; 110:9, s. 2597-2606
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Tidskriftsartikel (refereegranskat)abstract
- Aim This study presents dietary intake and physical activity in a large nationally representative sample of children and adolescents in Sweden. It also reports the study protocol for the Generation Pep Study that will be used for yearly repeated measurements. Methods A random sample of children and adolescents aged 4–17 years living in Sweden was invited to fill in a Web‐based questionnaire on dietary intake and physical activity. For participants aged <12 years, the parents were asked to fill in the questionnaire together with their child. Information on socio‐economic background was collected from the parents. Results A total number of 12,441 children and adolescents participated in the study (participation rate 43%). The results indicate that 13‐ to 17‐year‐olds have notably less healthy dietary intake and lower physical activity compared with younger age groups. In general, the dietary intake was most healthy among 4‐ to 6‐year‐olds. A socio‐economic gradient was seen for many of the studied variables. Conclusion Participants of a high socio‐economic status and younger age generally had healthier dietary intake and higher physical activity. The study provides novel national data as it includes a wide age of children and adolescents (4–17 years).
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| 53. |
- Ruiz-Pérez, María Victoria, et al.
(författare)
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Inhibition of fatty acid synthesis induces differentiation and reduces tumor burden in childhood neuroblastoma
- 2021
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Ingår i: iScience. - : Elsevier BV. - 2589-0042. ; 24:2
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Tidskriftsartikel (refereegranskat)abstract
- Many metabolic pathways, including lipid metabolism, are rewired in tumors to support energy and biomass production and to allow adaptation to stressful environments. Neuroblastoma is the second deadliest solid tumor in children. Genetic aberrations, as the amplification of the MYCN-oncogene, correlate strongly with disease progression. Yet, there are only a few molecular targets successfully exploited in the clinic. Here we show that inhibition of fatty acid synthesis led to increased neural differentiation and reduced tumor burden in neuroblastoma xenograft experiments independently of MYCN-status. This was accompanied by reduced levels of the MYCN or c-MYC oncoproteins and activation of ERK signaling. Importantly, the expression levels of genes involved in de novo fatty acid synthesis showed prognostic value for neuroblastoma patients. Our findings demonstrate that inhibition of de novo fatty acid synthesis is a promising pharmacological intervention strategy for the treatment of neuroblastoma independently of MYCN-status.
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| 54. |
- Sainero-Alcolado, Lourdes, et al.
(författare)
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Targeting MYC induces lipid droplet accumulation by upregulation of HILPDA in clear cell renal cell carcinoma
- 2024
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Ingår i: Proceedings of the National Academy of Sciences of the United States of America. - : Proceedings of the National Academy of Sciences (PNAS). - 1091-6490 .- 0027-8424. ; 121:7, s. 2310479121-2310479121
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Tidskriftsartikel (refereegranskat)abstract
- Metabolic reprogramming is critical during clear cell renal cell carcinoma (ccRCC) tumorigenesis, manifested by accumulation of lipid droplets (LDs), organelles that have emerged as new hallmarks of cancer. Yet, regulation of their biogenesis is still poorly understood. Here, we demonstrate that MYC inhibition in ccRCC cells lacking the von Hippel Lindau (VHL) gene leads to increased triglyceride content potentiating LD formation in a glutamine-dependent manner. Importantly, the concurrent inhibition of MYC signaling and glutamine metabolism prevented LD accumulation and reduced tumor burden in vivo. Furthermore, we identified the hypoxia-inducible lipid droplet-associated protein (HILPDA) as the key driver for induction of MYC-driven LD accumulation and demonstrated that conversely, proliferation, LD formation, and tumor growth are impaired upon its downregulation. Finally, analysis of ccRCC tissue as well as healthy renal control samples postulated HILPDA as a specific ccRCC biomarker. Together, these results provide an attractive approach for development of alternative therapeutic interventions for the treatment of this type of renal cancer.
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| 55. |
- Saladino, Giovanni, et al.
(författare)
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XFCT-MRI hybrid multimodal contrast agents for complementary imaging
- 2022
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Ingår i: Nanoscale. - : Royal Society of Chemistry (RSC). - 2040-3364 .- 2040-3372. ; 15:5, s. 2214-2222
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Tidskriftsartikel (refereegranskat)abstract
- Multimodal contrast agents in biomedical imaging enable the collection of more comprehensive diagnostic information. In the present work, we design hybrid ruthenium-decorated superparamagnetic iron oxide nanoparticles (NPs) as the contrast agents for both magnetic resonance imaging (MRI) and X-ray fluorescence computed tomography (XFCT). The NPs are synthesized via a one-pot polyol hot injection route, in diethylene glycol. In vivo preclinical studies demonstrate the possibility of correlative bioimaging with these contrast agents. The complementarity allows accurate localization, provided by the high contrast of the soft tissues in MRI combined with the elemental selectivity of XFCT, leading to NP detection with high specificity and resolution. We envision that this multimodal imaging could find future applications for early tumor diagnosis, improved long-term treatment monitoring, and enhanced radiotherapy planning.
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| 56. |
- Saluri, Mihkel, et al.
(författare)
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A “grappling hook” interaction connects self-assembly and chaperone activity of Nucleophosmin 1
- 2023
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Ingår i: pnas nexus. - : Oxford University Press (OUP). - 2752-6542. ; 2:2
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Tidskriftsartikel (refereegranskat)abstract
- How the self-assembly of partially disordered proteins generates functional compartments in the cytoplasm and particularly in the nucleus is poorly understood. Nucleophosmin 1 (NPM1) is an abundant nucleolar protein that forms large oligomers and undergoes liquid-liquid phase separation by binding RNA or ribosomal proteins. It provides the scaffold for ribosome assembly but also prevents protein aggregation as part of the cellular stress response. Here, we use aggregation assays and native mass spectrometry (MS) to examine the relationship between the self-assembly and chaperone activity of NPM1. We find that oligomerization of full-length NPM1 modulates its ability to retard amyloid formation in vitro. Machine learning-based structure prediction and cryo-electron microscopy reveal fuzzy interactions between the acidic disordered region and the C-terminal nucleotide-binding domain, which cross-link NPM1 pentamers into partially disordered oligomers. The addition of basic peptides results in a tighter association within the oligomers, reducing their capacity to prevent amyloid formation. Together, our findings show that NPM1 uses a grappling hook mechanism to form a network-like structure that traps aggregation-prone proteins. Nucleolar proteins and RNAs simultaneously modulate the association strength and chaperone activity, suggesting a mechanism by which nucleolar composition regulates the chaperone activity of NPM1.
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| 57. |
- Sandborg, Johanna, et al.
(författare)
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Participants’ Engagement and Satisfaction With a Smartphone App Intended to Support Healthy Weight Gain, Diet, and Physical Activity During Pregnancy : Qualitative Study Within the HealthyMoms Trial
- 2021
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Ingår i: JMIR mhealth and uhealth. - : JMIR publications. - 2291-5222. ; 9:3
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Tidskriftsartikel (refereegranskat)abstract
- Background:Excessive gestational weight gain (GWG) is common and associated with negative health outcomes for both mother and child. Mobile health–delivered lifestyle interventions offer the potential to mitigate excessive GWG. The effectiveness of a smartphone app (HealthyMoms) was recently evaluated in a randomized controlled trial. To explore the users’ experiences of using the app, a qualitative study within the HealthyMoms trial was performed.Objective:This qualitative study explored participants’ engagement and satisfaction with the 6-month usage of the HealthyMoms app.Methods:A total of 19 women (mean age: 31.7, SD 4.4 years; mean BMI: 24.6, SD 3.4 kg/m2; university degree attainment: 13/19, 68%; primiparous: 11/19, 58%) who received the HealthyMoms app in a randomized controlled trial completed semistructured exit interviews. The interviews were audiorecorded and fully transcribed, coded, and analyzed using thematic analysis with an inductive approach.Results:Thematic analysis revealed a main theme and 2 subthemes. The main theme, “One could suit many: a multifunctional tool to strengthen women’s health during pregnancy,” and the 2 subthemes, “Factors within and beyond the app influence app engagement” and “Trust, knowledge, and awareness: aspects that can motivate healthy habits,” illustrated that a trustworthy and appreciated health and pregnancy app that is easy to use can inspire a healthy lifestyle during pregnancy. The first subtheme discussed how factors within the app (eg, regular updates and feedback) were perceived to motivate both healthy habits and app engagement. Additionally, factors beyond the app were described to both motivate (eg, interest, motivation, and curiosity) and limit (eg, pregnancy-related complications, lack of time) app engagement. The second subtheme reflected important aspects, such as high trustworthiness of the app, increased knowledge, and awareness from using the app, which motivated participants to improve or maintain healthy habits during pregnancy.Conclusions:The HealthyMoms app was considered a valuable and trustworthy tool to mitigate excessive GWG, with useful features and relevant information to initiate and maintain healthy habits during pregnancy.
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| 58. |
- Shaker, Kian, et al.
(författare)
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Longitudinal In-Vivo X-Ray Fluorescence Computed Tomography With Molybdenum Nanoparticles
- 2020
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Ingår i: IEEE Transactions on Medical Imaging. - : Institute of Electrical and Electronics Engineers (IEEE). - 0278-0062 .- 1558-254X. ; 39:12, s. 3910-3919
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Tidskriftsartikel (refereegranskat)abstract
- X-ray fluorescence computed tomography (XFCT) with nanoparticles (NPs) as contrast agents shows potential for molecular biomedical imaging with higher spatial resolution than present methods. To date the technique has been demonstrated on phantoms and mice, however, parameters such as radiation dose, exposure times and sensitivity have not yet allowed for high-spatial-resolution in vivo longitudinal imaging, i.e., imaging of the same animal at different time points. Here we show in vivo XFCT with spatial resolution in the 200-400 mu m range in a proof-of-principle longitudinal study where mice are imaged five times each during an eight-week period following tail-vein injection of NPs. We rely on a 24 keV x-ray pencil-beam-based excitation of in-house-synthesized molybdenum oxide NPs (MoO2) to provide the high signal-to-background x-ray fluorescence detection necessary for XFCT imaging with low radiation dose and short exposure times. We quantify the uptake and clearance of NPs in vivo through imaging, and monitor animal well-being over the course of the study with support from histology and DNA stability analysis to assess the impact of x-ray exposure and NPs on animal welfare. We conclude that the presented imaging arrangement has potential for in vivo longitudinal studies, putting emphasis on designing biocompatible NPs as the future focus for active-targeting preclinical XFCT.
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| 59. |
- Shaker, Kian, et al.
(författare)
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Phase-contrast X-ray tomography resolves the terminal bronchioles in free-breathing mice
- 2021
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Ingår i: Communications Physics. - : Springer Nature. - 2399-3650. ; 4:1
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Tidskriftsartikel (refereegranskat)abstract
- Mechanical ventilation of living animals is routinely used to achieve high-resolution pulmonary imaging, but this can damage the subject. Here, an alternative, free-breathing method enables X-ray tomography with 30 mu m resolution. Phase-contrast X-ray lung imaging has broken new ground in preclinical respiratory research by improving contrast at air/tissue interfaces. To minimize blur from respiratory motion, intubation and mechanical ventilation is commonly employed for end-inspiration gated imaging at synchrotrons and in the laboratory. Inevitably, the prospect of ventilation induced lung injury (VILI) renders mechanical ventilation a confounding factor in respiratory studies of animal models. Here we demonstrate proof-of-principle 3D imaging of the tracheobronchial tree in free-breathing mice without mechanical ventilation at radiation levels compatible with longitudinal studies. We use a prospective gating approach for end-expiration propagation-based phase-contrast X-ray imaging where the natural breathing of the mouse dictates the acquisition flow. We achieve intrapulmonary spatial resolution in the 30-mu m-range, sufficient for resolving terminal bronchioles in the 60-mu m-range distinguished from the surrounding lung parenchyma. These results should enable non-invasive longitudinal studies of native state murine airways for translational lung disease research in the laboratory.
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| 60. |
- Thomas, Kristin, et al.
(författare)
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Associations of Psychosocial Factors with Multiple Health Behaviors : A Population-Based Study of Middle-Aged Men and Women
- 2020
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Ingår i: International Journal of Environmental Research and Public Health. - : MDPI. - 1661-7827 .- 1660-4601. ; 17:4
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Tidskriftsartikel (refereegranskat)abstract
- Background: The health behaviors smoking, risky alcohol consumption, insufficient physical activity, and poor diet constitute the main contributors to non-communicable diseases. Clustering of risk behaviors is common and increases the risk of these diseases. Despite health benefits, it is difficult to change health behaviors. Psychosocial factors could play a role in health behavior change, with research showing relationships between unfavorable psychosocial factors and health risk behaviors. However, many studies only investigated one or two health behaviors at a time. The present study, therefore, aimed to investigate associations between a broad range of psychosocial factors and multiple health risk behaviors in a general middle-aged population in Sweden. Methods: A cross-sectional design was used to investigate a random sample from the general population in Sweden (n = 1007, 45-69 years, 50% women). Questionnaire data on health behaviors (smoking, alcohol consumption, physical activity, and fruit/vegetable intake) and psychosocial factors, with both psychological and social resources (social integration, emotional support, perceived control, self-esteem, sense of coherence and trust) and psychological risk factors (cynicism, vital exhaustion, hopelessness and depressiveness), were analyzed. Logistic and ordinal logistic regression were used to analyze associations between psychosocial factors and multiple (0-1, 2 or 3-4) health risk behaviors. Results: A total of 50% of the sample had two health risk behaviors and 18% had three health risk behaviors. After adjusting for age, sex, education, employment status, and immigrant status, eight out of 10 psychosocial factors (exceptions: social integration and self-esteem) showed significant odds ratios (ORs) in the expected directions; low levels of psychosocial resources and high levels of psychosocial risk factors were associated with multiple risk behaviors. The strongest associations with multiple risk behaviors were seen for vital exhaustion (adjusted (adj.) OR 1.28; confidence interval (CI) 1.11-1.46), depressiveness (adj. OR 1.32, CI 1.14-1.52), and trust (adj. OR 0.80, CI 0.70-0.91). When controlling for all psychosocial factors in the same model, only the association with trust remained statistically significant (adj. OR 0.89, CI 0.73-1.00, p = 0.050). Associations with individual health behaviors were fewer and scattered, with no psychosocial factor being related to all four behaviors. Conclusions: Examining associations between a broad range of psychosocial factors and multiple health risk behaviors revealed consistent and significant associations for almost all psychosocial factors. These associations were stronger compared to associations to single health risk behaviors. Our findings support the relevance of considering psychosocial aspects in interventions aimed at health behavior change, especially for people with multiple health risk behaviors.
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| 61. |
- Thomas, Kristin, 1978-, et al.
(författare)
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Mobile phone-based lifestyle support for families with young children in primary health care (MINISTOP 2.0) : Exploring behavioral change determinants for implementation using the COM-B model.
- 2022
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Ingår i: Frontiers in Health Services. - : Frontiers Media S.A.. - 2813-0146. ; 2
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Obesity in childhood is a public health concern worldwide and mobile phone-based interventions (mHealth) has shown to facilitate obesity prevention. However, more research is needed on the implementation of digital tools in routine primary care. This study explored behavior change determinants for implementing a health promotion mHealth intervention (MINISTOP 2.0 app) targeting parents of 4-year-olds.METHODS: Secondary data from telephone interviews (n = 15) with child health care nurses working within primary child healthcare in Sweden was analyzed using directed content analysis and the COM-B model.RESULTS: Barriers for implementation included: limited knowledge about using technology and reservations about how and to what extent parents would use mHealth. Potential facilitators included nurses' openness to learn and try new tools, confidence in their role and engagement in reaching parents as well as beliefs that the app could improve practice by prompting dialogue and being a shared platform. Nurses expressed a strong professional identity and shared understanding of their practice, mechanisms that could potentially inhibit or facilitate implementation.CONCLUSIONS: Findings suggest cautious optimism regarding implementing mobile phone-based tools in child primary healthcare in terms of capability, opportunity and motivation among stakeholders. Implementation strategies such as educational outreach visits and making the intervention testable among stakeholders could further facilitate implementation in this clinical context. However, more research is needed on behavior change determinants in different stages of real-world implementation.
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| 62. |
- Torres-Lopez, Lucia V, et al.
(författare)
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Associations of Sleep-Related Outcomes with Behavioral and Emotional Functioning in Children with Overweight/Obesity
- 2022
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Ingår i: The Journal of Pediatrics. - : Elsevier. - 0022-3476 .- 1097-6833. ; 246, s. 170-178.e2
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Tidskriftsartikel (refereegranskat)abstract
- Objective To evaluate the associations of parent-reported sleep-disordered breathing (SDB) and device-assessed sleep behaviors with behavioral and emotional functioning in pediatric patients with overweight/obesity. Study design A total of 109 children with overweight/obesity (mean age, 10.0 +/- 1.1 years) were included in this cross-sectional study. We used the Spanish version of the Pediatric Sleep Questionnaire (PSQ) to assess SDB and its subscales (ie, snoring, daytime sleepiness, and inattention/hyperactivity). Device-assessed sleep behaviors (ie, wake time, sleep onset time, total time in bed, total sleep time, and waking after sleep onset) were estimated using wrist-worn accelerometers. We used the Behavior Assessment System for Children, second edition to assess behavioral and emotional functioning (ie, clinical scale: aggressiveness, hyperactivity, behavior problems, attention problems, atypicality, depression, anxiety, retreat, and somatization; adaptive scale: adaptability, social skills, and leadership). Results SDB was positively associated with all clinical scale variables (all beta > 0.197, P <=.041) and with lower adaptability and leadership (all beta < -0.226, P < .021). Specifically, the PSQ subscale relating to daytime sleepiness was associated with higher attention problems, depression, anxiety, and retreat (all beta > 0.196, P .045) and lower adaptability (beta = -0.246, P = .011). The inattention/hyperactivity subscale was significantly associated with the entire clinical and adaptive scales (all beta > vertical bar 0.192 vertical bar, P <= .046) except for somatization. The snoring subscale and device-assessed sleep behaviors were not related to any behavioral or emotional functioning variables. Conclusions Our study suggests that SDB symptoms, but not device-assessed sleep behaviors, are associated with behavioral and emotional functioning in children with overweight/obesity. Specifically, daytime sleepiness, a potential SDB symptom, was related to higher attention problems, depression, anxiety, and retreat and lower adaptability.
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| 63. |
- Torres-Lopez, Lucia V., et al.
(författare)
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Effects of exercise on sleep in children with overweight/obesity: a randomized clinical trial
- 2023
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Ingår i: Obesity. - : WILEY. - 1930-7381 .- 1930-739X.
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveThe objective of this study was to examine the chronic effects of a 20-week exercise training program on device-assessed sleep and sleep-disordered breathing; and to determine whether participating in a session of the exercise program had effects on device-assessed sleep the subsequent night in children with overweight/obesity.MethodsA randomized clinical trial was conducted from November 2014 to June 2016. A total of 109 children (age 8-11 years) with overweight/obesity were randomized into an exercise training or control group. The exercise program included aerobic and resistance training 3 to 5 days/week. The control group participants continued their usual lifestyle. Device-assessed sleep outcomes were measured using wrist-worn actigraphy at baseline, in the middle of the exercise program (10th week), and at postintervention for seven consecutive days (24 h/day), and sleep-disordered breathing was measured via the Pediatric Sleep Questionnaire.ResultsThe exercise training program had a statistically significant effect on wake after sleep onset time (-10.8 min/day, -0.5 SDs, p = 0.040). No other chronic or acute effects (i.e., the subsequent night of attending a session of the exercise training program) were observed on the remaining sleep outcomes.ConclusionsA 20-week exercise training program reduced wake after sleep onset time in children with overweight/obesity. Future randomized trials that include a sample of children with poor sleep health at baseline are needed to better appreciate the role of exercise in sleep health.
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| 64. |
- Vogt, Carmen, et al.
(författare)
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Organ uptake, toxicity and skin clearance of ruthenium contrast agents monitored in vivo by x-ray fluorescence
- 2023
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Ingår i: Nanomedicine. - : Future Medicine Ltd. - 1743-5889 .- 1748-6963. ; 18:18, s. 1161-1173
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To investigate the distribution and toxicity of ruthenium nanoparticles (Ru NPs) injected intravenously in mice.Methods: We synthesized Ru NPs, followed their biodistribution by x-ray fluorescence (XRF) imaging and evaluated organ toxicity by histopathology and gene expression.Results: Ru NPs accumulated, mainly in liver and spleen, where they were phagocyted by tissue macrophages, giving a transient inflammation and oxidative stress response that declined after 2 weeks. Ru NPs gradually accumulated in the skin, which was confirmed by microscopic examination of skin biopsies.Conclusion: Ru NP toxicity in recipient organs is transient. Particles are at least partially excreted by the skin, supporting a role for the skin as a nanoparticle clearing organ.
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| 65. |
- Wode, Kathrin, et al.
(författare)
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Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer : study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL)
- 2020
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Ingår i: Trials. - : BioMed Central. - 1745-6215. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported.The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life.Methods: The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20 mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews.Discussion: To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer.
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| 66. |
- Wode, Kathrin, 1968-, et al.
(författare)
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Mistletoe extract in patients with advanced pancreatic cancer : a double-blind, randomized, placebo-controlled trial (MISTRAL)
- 2024
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Ingår i: Deutsches Ärzteblatt International. - : Deutscher Arzte-Verlag GmbH. - 1866-0452. ; 121:11, s. 347-354
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Tidskriftsartikel (refereegranskat)abstract
- Background: Patients with advanced pancreatic cancer have limited survival and few treatment options. We studied whether mistletoe extract (ME), in addition to comprehensive oncological treatment and palliative care, prolongs overall survival (OS) and improves health-related quality of life (HRQoL).Methods: The double-blind, placebo-controlled MISTRAL trial was conducted in Swedish oncology centers. The main inclusion criteria were advanced exocrine pancreatic cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0–2. The subjects were randomly assigned to ME (n=143) or placebo (n=147) and were stratified by study site and by eligibility (yes/no) for palliative chemotherapy (June 2016–December 2021). ME or placebo was injected subcutaneously three times a week for nine months. The primary endpoint was overall survival (OS); one of the secondary endpoints was the HRQoL dimension global health/ QoL (EORTC–QLQ–C30), as assessed at seven time points over nine months.Trial registration: EudraCT 2014–004552–64, NCT02948309Results: No statistically significant benefit of adding ME to standard treatment was seen with respect to either OS or global health/ QoL. The adjusted hazard ratio for OS was 1.13 [0.89; 1.44], with a median survival time of 7.8 and 8.3 months for ME and placebo, respectively. The figures for the HRQoL dimension “global health/QoL” were similar in the two groups (p=0.86). The number, severity, and outcome of the reported adverse events were similar as well, except for more common local skin reactions at ME injection sites (66% vs. 1%).Conclusion: ME is unlikely to have a clinically significant effect on OS or the HRQoL dimension global health/QoL when administered in patients with advanced pancreatic cancer in addition to comprehensive cancer care.
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