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Patient characteristics | MAY | From May 2020 to September 2020, a total of 102 eligible patients were randomly assigned into the study. One patient in control intervention group withdrew consent and 1 patient failed to complete radiotherapy. One patient in Sanyrene group was excluded from final analysis due to incomplete radiotherapy. Ultimately, 99... | PMC10604398 | |
Efficacy | toxicity, dermatitis, skin toxicity, skin toxicities | BREAST CANCER, HEAD AND NECK CANCER, SKIN TOXICITIES, ONCOLOGY, DERMATITIS, SKIN TOXICITY | All patients completed their follow-up records at 4 weeks post-radiotherapy. Of all patients, 55 patients (55.5%) experienced grade 1 skin toxicity, 30 patients (30.3%) experienced grade 2 toxicity, and 14 patients (14.1%) experienced grade 3 skin toxicity during the whole treatment and follow-up period. None of patien... | PMC10604398 |
Discussion | toxicity, pain, head and neck cancer, dermatitis, skin toxicity, cutaneous inflammation | DISEASE, HEAD AND NECK CANCER, BLIND, DERMATITIS, SKIN TOXICITY | To our knowledge, this is the first study to identify the prophylactic effect of Sanyrene- a liquid dressing with linoleic acid and linolenic acid mixture in radiotherapy induced dermatitis. In this study, we found Sanyrene significantly reduced the incidence rate of ≥ grade 2 RD when compared to control intervention. ... | PMC10604398 |
Conclusion | head and neck cancer, breast cancer | HEAD AND NECK CANCER, BREAST CANCER | This trial suggests that Sanyrene is effective on preventing serious RD and improving skin related Qol in patients with breast cancer and head and neck cancer receiving radiotherapy. However, these results should be further validated by trials with rigorous design. | PMC10604398 |
Acknowledgements | Not applicable. | PMC10604398 | ||
Author contributions | X.L. and J.G. contributed to the preparation of manuscript and interpretation of the data. Y.Y. contributed to the the analysis and interpretation of the data. M.C., X.Z., J.Z. and P.W. contributed to the collection of data. J.Z. and L.Z. contributed to the design of the study and critical revision of the manuscript. A... | PMC10604398 | ||
Funding | No funding was received for this study. | PMC10604398 | ||
Data Availability | All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author. | PMC10604398 | ||
Declarations | PMC10604398 | |||
Competing interests | The authors declare no competing interests. | PMC10604398 | ||
Ethics approval and consent to participate | This study was approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University (ethical approval number: KY20202016-F-1). Written informed consent was obtained from participants to participate in the study. | PMC10604398 | ||
Consent for publication | Not applicable. | PMC10604398 | ||
References | PMC10604398 | |||
Abstract | PMC10448250 | |||
Objective | To determine the effects of salt reduction interventions designed for home cooks and family members. | PMC10448250 | ||
Design | Cluster randomised controlled trial. | PMC10448250 | ||
Setting | Six provinces in northern, central, and southern China from 15 October 2018 to 30 December 2019. | PMC10448250 | ||
Participants | 60 communities from six provinces (10 communities from each province) were randomised; each community comprised 26 people (two people from each of 13 families). | PMC10448250 | ||
Interventions | Participants in the intervention group received 12 month interventions, including supportive environment building for salt reduction, six education sessions on salt reduction, and salt intake monitoring by seven day weighed record of salt and salty condiments. The control group did not receive any of the interventions. | PMC10448250 | ||
Main outcome measure | Difference between the two groups in change in salt intake measured by 24 hour urinary sodium during the 12 month follow-up. | PMC10448250 | ||
Results | 1576 participants (775 (49.2%) men; mean age 55.8 (standard deviation 10.8) years) from 788 families (one home cook and one other adult in each family) completed the baseline assessment. After baseline assessment, 30 communities with 786 participants were allocated to the intervention group and 30 communities with 790 ... | PMC10448250 | ||
Conclusions | The community based salt reduction package targeting home cooks and family members was effective in lowering salt intake and blood pressure. This intervention has the potential to be widely applied in China and other countries where home cooking remains a major source of salt intake. | PMC10448250 | ||
Trial registration | Chinese Clinical Trial Registry ChiCTR1800016804. | PMC10448250 | ||
Introduction | stroke | KIDNEY DISEASE, HEART DISEASE, STROKE, HYPERTENSION, GASTRIC CANCER | Excess dietary salt consumption is a major risk factor for hypertension, stroke, heart disease, kidney disease, and gastric cancer.Salt reduction has been adopted as one of the most cost effective public health policies worldwide. The World Health Organization and the United Nations Food and Agriculture Organization is... | PMC10448250 |
Methods | PMC10448250 | |||
Study design | A parallel cluster randomised controlled trial was conducted between October 2018 and December 2019 in communities from six cities in six provinces—Qinghai, Hebei, Heilongjiang, Sichuan, Jiangxi, and Hunan. A detailed design has been published elsewhere. | PMC10448250 | ||
Participants | Twenty six adults from 13 families, two from each including the usual cook, were recruited from each community for outcome evaluation. Eligible people were aged between 18 and 75 years and were home cooks and family members who ate homemade meals at least four times every week. If more than one family member in a famil... | PMC10448250 | ||
Interventions | DISEASE | The intervention included health education lectures, monitoring of salt intake, and establishment of a supportive environment. The intervention lasted for one year.The lectures comprised six sessions of education on salt reduction, disseminating knowledge on the harmful effects of high sodium intake on health, the sour... | PMC10448250 | |
Outcomes | SECONDARY | The primary outcome was the difference between the two groups in the change from baseline to follow-up in salt intake measured by 24 hour urinary sodium. The secondary outcomes were the differences in the change in blood pressure and in knowledge, attitude, and behaviours between the two groups.Data were collected by w... | PMC10448250 | |
Sample size | We assumed a standard deviation for 24 hour urinary sodium excretion of 85 mmol/24 hours (1960 mg/day) and an intra-class correlation coefficient of 0.05. | PMC10448250 | ||
Randomisation and masking | RECRUITMENT | The 60 communities were assigned to the intervention group or the control group in a one to one ratio. Randomisation was computer generated centrally by the Chinese CDC, stratified by provinces. The randomisation procedure was carried out after the baseline survey, and the participants and local investigators who under... | PMC10448250 | |
Statistical analysis | hypertension | SECONDARY, HYPERTENSION | We analysed the data according to the intention-to-treat principle. Participants who completed the baseline survey were analysed according to their randomly assigned group. We compared the difference in 24 hour urinary sodium excretion, as well as the secondary outcomes, between the two groups by using linear mixed mod... | PMC10448250 |
Patient and public involvement | Provincial CDCs, county level CDCs, and primary healthcare centres were involved in the design and conduct of this study. At the protocol stage, we gained their opinions on the content of the intervention and the electronic data collection system. Personnel at the county level CDCs helped to translate the educational m... | PMC10448250 | ||
Results | REGRESSION, POSITIVE | We recruited 60 communities (10 in each province) into the study in October 2018. A total of 1576 participants from 788 families completed the baseline survey. The mean age was 55.8 (standard deviation 10.8) years, and 775 (49.2%) were male. During the trial, 157 (10%) participants were lost to follow-up as they moved ... | PMC10448250 | |
Discussion | We developed a set of community based salt reduction interventions targeting home cooks and family members. This cluster randomised controlled trial showed that the intervention package not only effectively reduced the urinary sodium excretion by 336.8 mg/day (0.9 g/day salt reduction) but also lowered systolic blood p... | PMC10448250 | ||
Comparison with other studies | Hg lower mean systolic blood pressure | Our results showed that the reduction in urinary sodium excretion was accompanied by a decrease in blood pressure, especially systolic blood pressure. A recent meta-analysis of randomised salt reduction trials found that every 100 mmol/day (2.3 g/day) reduction in urinary sodium excretion was associated with a 5.56 (95... | PMC10448250 | |
Strengths and limitations of study | This was a large scale, community based salt reduction study targeting families in communities in eastern, central, and western regions of China. A stringent and standardised protocol was implemented at all study sites, with a high follow-up rate of 90%. An electronic data collection system was used to ensure high qual... | PMC10448250 | ||
Conclusions and public health implications | EVENTS, AIDS | This study showed that the comprehensive salt reduction interventions targeting home cooks and family members were effective in terms of both urinary sodium and blood pressure reduction. The reduction of 0.9 g/day in salt intake observed in our study seems modest; however, it has substantial public health significance ... | PMC10448250 | |
What is already known on this topic | disease burdenSalt reduction | Salt intake in China is more than double the recommended limit, which causes a heavy disease burdenSalt reduction is a cost effective public health policyMost dietary salt in China is added during home cooking, but evidence from randomised controlled trials of interventions targeting home cooks has been lacking | PMC10448250 | |
What this study adds | cardiovascular diseasesWe | DISEASE, CARDIOVASCULAR DISEASES | A package of community based salt reduction interventions for home cooks and family members to gain knowledge of and develop skills in salt reduction has been developedThese interventions were feasible and effective in improving salt reduction behaviours and reducing urinary sodium excretion and blood pressureThis inte... | PMC10448250 |
Ethics statements | PMC10448250 | |||
Ethical approval | DISEASE | The study protocol was approved by Queen Mary (University of London) Ethics of Research Committee (QMERC2018/13) and the Institutional Review Board of the Chinese Center for Disease Control and Prevention (No 201801). All participants who took part in the outcome assessments gave written informed consent. | PMC10448250 | |
Data availability statement | DISEASE | Relevant anonymised individual level data will be made available one year after publication of the primary manuscript on request from the corresponding authors. Request for data sharing will be handled in line with the relevant regulations for data access and sharing in China and will need the approval of the trial ste... | PMC10448250 | |
Subject terms | While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab... | PMC10276829 | ||
Introduction | infection, death, illness | CORONAVIRUS, INFECTION, ADENOVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | Adenovirus vector, mRNA, and protein subunit vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are highly effective in reducing the incidence of symptomatic infection, severe illness, hospitalization, and death due to COVID-19Antiviral mAbs are effective in the treatment and prevention of CO... | PMC10276829 |
Results | PMC10276829 | |||
Neutralization titer kinetics | For participants in the monoclonal antibody COV-2069 trial, the median half-life of the neutralization titer was 26 days. For vaccinated individuals in the COVE trial, the estimated half-life was 70 days. The predicted nAb kinetics of 10 randomly selected COV-2069 and COVE participants over the course of their respecti... | PMC10276829 | ||
Predicted pseudo-virus neutralization titer by days since full immunization (day 1 for mAbs, day 57 for vaccine) for ten randomly selected participants from the COVE immunogenicity subcohort (gold) and COV-2969 (green) trials. | EVENT, DECAY | The COVE lines use the measured Day 57 neutralization titer (red circle) with subsequent decay determined by a common slope estimated from independent data. Casirivimab + imdevimab mAb lines use concentration curves based on sex and weight and subsequently converted to neutralization titer. The curves start at day 8 da... | PMC10276829 | |
Monoclonal antibody (casirivimab + imdevimab) preventive efficacy | The cumulative incidence of COVID-19 by randomization group is given in Supplementary Fig. | PMC10276829 | ||
Vaccine (mRNA-1273) efficacy | Starting 7 days after the day 57 visit through the end of the blinded phase, a total of 47 vaccine group participants and 659 placebo group participants acquired COVID-19 resulting in an estimated VE of 100% x (1–48/659) = 92.6%. The cumulative incidence of COVID-19 by arm is given in Supplementary Fig. | PMC10276829 | ||
Efficacy curves for the monoclonal antibody combination (casirivimab + imdevimab) and mRNA-1273 vaccine | The relationship between predicted log10 nAb titer at the time of exposure and protection against COVID-19 is shown in Fig. | PMC10276829 | ||
Protective efficacy (PE) of casirivimab + imdevimab mAbs (solid green curve) and vaccine efficacy (VE) of mRNA-1273 (dashed orange curve) against COVID-19 as a function of predicted pseudo-virus neutralization titer at the time of exposure. | Shaded area provides 95% pointwise confidence intervals with lighter green emphasizing greater uncertainty for lower titers. PE and VE curves cover the distribution of titers achieved during follow-up with no extrapolation. | PMC10276829 | ||
Quantifying the role of extant nAb titers in vaccine induced protection | We deconstructed the total vaccine effect as the product of an extant nAb titer effect times all other vaccinal effects beyond extant nAb titer. The analysis suggests that at a predicted neutralization titer of 1000 IU50/ml, the percent of total vaccine efficacy due to extant antibody was 72% (95% CI: 50%, 100%) and th... | PMC10276829 | ||
In mRNA-1273 vaccine disease cases nAb titers rise in those with lower titers | DISEASE | To further investigate the effect of an anamnestic versus extant antibody response in protection, we evaluated the kinetics of antibody levels in vaccinated disease cases during the blinded phase of the COVE trial | PMC10276829 | |
Binding antibody concentration and neutralization titers at 28 days post second dose, the onset of COVID-19 symptoms, and 28 days later in vaccinated participants who acquired COVID-19 during the blinded phase of COVE. | Day 0 is the onset of symptoms. | PMC10276829 | ||
Discussion | SARS | Although the mRNA-1273 vaccine and casirivimab + imdevimab mAbs for COVID-19 prevention have high efficacy over the duration studied, the relative contribution of antibody at the time of exposure differs. For nAb titers greater than 1000 IU50/ml, the clinical efficacy of both mRNA-1273 and casirivimab + imdevimab to pr... | PMC10276829 | |
A schematic illustrating the role of extant circulating and possibly mucosal antibodies in vaccine induced protection. | infection, nAbs | INFECTION, DISEASE, EMERGENCY | Four identical exposure scenarios are depicted. At a higher neutralization titer e.g., 1000 IU50/ml, extant antibody alone results in protection with no need for engagement of B cells, T cells, or other vaccine induced elements. At a lower titer e.g., <100 IU50/ml, mAb antibody alone is not enough for high protection. ... | PMC10276829 |
Methods | PMC10276829 | |||
Study design and population: casirivimab + imdevimab mAb prevention trial | Details of the casirivimab + imdevimab COV-2069 clinical trial for the prevention of COVID-19 are described elsewhereThe analysis set of participants without SARS-CoV-2 through day 8, included 829 and 801 participants in the mAb, and placebo arms, respectively (Supplementary Table The mAb and placebo arm participants d... | PMC10276829 | ||
Study design and population: COVE mRNA-1273 vaccine trial | DISEASE | Details of the COVE trial through the end of the blinded phase are published elsewhereGilbert et alWe also used data from Follmann, Janes et al., who evaluated the kinetics of the antibody response to disease during the blinded phase of COVE, for supportive analysisA schematic of the two studies is given in Fig. | PMC10276829 | |
Schematic of the COV-2069 mAb prevention trial and mRNA-1273 vaccine trial (COVE) as analyzed in this report. | ASYMPTOMATIC COVID-19 | Both trials were conducted before the emergence of the Omicron VOC in trial participants, had similar populations, enrolled SARS-CoV-2 naïve individuals, and had similar definitions of symptomatic COVID-19 illness. | PMC10276829 | |
Neutralizing antibody data | For COV-2069 trial participants, pharmacokinetic (PK) antibody concentration curves of casirivimab and imdevimab in serum over 8-months were estimated using population PK models developed for casirivimab and imdevimab from three clinical studies. The population PK models were two compartment models with linear eliminat... | PMC10276829 | ||
Statistical analyses | REGRESSION, DECAY | For each individual in each trial a predicted neutralization titer on each day throughout follow-up was constructed as follows. The relationship between log10 mAb concentration of casirivimab + imdevimab and log10 pseudovirus neutralization titer was estimated using linear regression. For each participant in the COV-20... | PMC10276829 | |
Reporting summary | Further information on research design is available in the | PMC10276829 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-39292-w. | PMC10276829 | ||
Acknowledgements | Cancer | INFECTIOUS DISEASES, ALLERGY, CANCER | We thank the volunteers who participated in the COV-2069 and COVE clinical trials. We thank Heather Angier for assistance with technical editing. This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. 75N91019D00024. The ... | PMC10276829 |
Author contributions | D.M., A.M. | Conceptualization: D.F., M.M., and M.F. Methodology: D.F., M.F., and J.F. Formal Analysis: D.F., M.F., J.F., and A.M. Writing – original draft: D.F., M.C., M.O.B., and M.M. Writing – review & editing: D.F., J.F., M.P.F., D.M., A.M., H.M.E.S., H.J., N.D.-R., D.B., Y.F., M.M., M.P.O., G.A.H., A.H., K.-C.C., E.F.-N., K.C.... | PMC10276829 | |
Peer review | PMC10276829 | |||
Funding | Open Access funding provided by the National Institutes of Health (NIH). | PMC10276829 | ||
Data availability | For COV-2069Qualified researchers can request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymised participant data will be consi... | PMC10276829 | ||
Code availability | Code to estimate the proportional hazards models used in the manuscript are available on github | PMC10276829 | ||
Competing interests | D.M., A.M., A.H. owns stock | D.F., J.F., M.P.F., D.M., A.M., H.M.E.S., H.J., N.D.-R., D.B., Y.F., and M.M. have no competing interests to declare. M.P.O. is an employee, has stock options, a patent pending, and license and royalties with Regeneron Pharmaceuticals, Inc. G.A.H. is an employee and shareholder of Regeneron and is listed on pending pat... | PMC10276829 | |
Ethics approval | We have complied with all relevant ethical regulations in analyzing these data. For COV-2069 the central or local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. The central IRB was WCG-IRB For COVE a central institutional review board, Advarra, approved the ... | PMC10276829 | ||
References | PMC10276829 | |||
Purpose | ovarian cancer | ADVERSE EVENTS, OVARIAN CANCER | To determine the systemic exposure to cisplatin and paclitaxel after adjuvant intraperitoneal administration in patients with advanced ovarian cancer who underwent primary debulking surgery. This could provide an explanation for the high incidence of systemic adverse events associated with this treatment regimen. | PMC10033566 |
Methods | ovarian cancer | ADVERSE EVENTS, OVARIAN CANCER | This is a prospective pharmacokinetic study in patients with newly diagnosed advanced ovarian cancer who were treated with intraperitoneal administered cisplatin and paclitaxel. Plasma and peritoneal fluid samples were obtained during the first treatment cycle. The systemic exposure to cisplatin and paclitaxel was dete... | PMC10033566 |
Results | Pharmacokinetics of ultrafiltered cisplatin were studied in eleven evaluable patients. The geometric mean [range] peak plasma concentration (C | PMC10033566 | ||
Conclusion | ADVERSE EVENTS | Systemic exposure to ultrafiltered cisplatin after intraperitoneal administration is high. In addition to a local effect, this provides a pharmacological explanation for high incidence of adverse events seen after intraperitoneal administration of high-dose cisplatin. The study was registered at ClinicalTrials.gov unde... | PMC10033566 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00280-023-04512-z. | PMC10033566 | ||
Keywords | PMC10033566 | |||
Introduction | cancers, Ovarian cancer, cancer of the female reproductive system, gynaecological malignancies, deaths, hyperthermia | CANCERS, CATHETER COMPLICATIONS, ADVERSE EVENTS, ADVERSE EVENT, OVARIAN CANCER STAGE IIA, OVARIAN CANCER, EPITHELIAL OVARIAN CANCER, CAVITY, EVENTS | Ovarian cancer is a common type of cancer of the female reproductive system. Globally approximately 295,000 new diagnoses and 185,000 deaths were reported in the year 2018, which reflects a mortality-to-incidence ratio of approximately 0.6 which is the highest of all gynaecological cancers [Although first-line platinum... | PMC10033566 |
Materials and methods | PMC10033566 | |||
Patients and data collection | primary peritoneal cancer | FALLOPIAN TUBE, RESIDUAL DISEASE, ADVERSE EVENTS, EPITHELIAL OVARIAN CANCER | Eligible patients aged between 18 and 70 years, with newly diagnosed stage III epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer, with optimal or complete primary debulking (residual disease ≤ 1 cm), a World Health Organisation (WHO) performance status of 0–2, normal blood counts and ade... | PMC10033566 |
Treatment plan | Patients were treated with adjuvant chemotherapy after primary debulking surgery according to GOG-172 [ | PMC10033566 | ||
Pharmacokinetic sampling and analytical assay | BLOOD | Samples for assessment of pharmacokinetics were taken during the first cycle only, on day 2 and day 8. Blood samples were obtained from an indwelling canula in EDTA tubes as follows: before infusion, 15, 30 min, 1, 2, 4, 8, 16, 24 h after the end of the intraperitoneal chemotherapy infusion. A peritoneal fluid sample w... | PMC10033566 | |
Population pharmacokinetic model | Cisplatin data (i.e., ultrafiltered peritoneal and plasma concentrations, and plasma protein bound concentrations obtained by difference between total and ultrafiltered plasma concentrations) were analyzed simultaneously by non-linear mixed effects modeling with NONMEM version 7.4.1 (ICON Development Solutions, Ellicot... | PMC10033566 | ||
Results | PMC10033566 | |||
Pharmacokinetics of ultrafiltered cisplatin | Plasma ultrafiltered and total cisplatin PK data were available from eleven patients. Intraperitoneal fluid samples were available from six patients at the end of cisplatin administration. A total of 147 samples (6 IP, 71 UF and 70 PB cisplatin concentrations) were used to estimate pharmacokinetics parameters. The fina... | PMC10033566 | ||
Discussion | toxicity, ototoxicity, tumour | ADVERSE EVENTS, CAVITY, TUMOUR, OTOTOXICITY, PERIPHERAL NEUROPATHY | This study demonstrates that intraperitoneal administration of 100 mg/mSystemic exposure to unbound cisplatin is closely correlated with tumour response [The high systemic exposure to ultrafiltered cisplatin after intraperitoneal administration might be caused by higher fraction of complexed cisplatin to low weight mol... | PMC10033566 |
Acknowledgements | We thank all the patients for their participation and all the personnel at the clinical site for collecting and processing the pharmacokinetic samples. We specially thank Mark Rietveld, Floor Ploos van Amstel, Laura Dobbe, Sabrina Marsili and Thierry Laffont for their support. | PMC10033566 | ||
Author contributions | Study design: PBO and NPvE; data collection: LAWdJ and LdV; data analysis and interpretation: LAWdJ, ML and LdV; analysis: ML and EC; manuscript writing: LAWdJ, ML and LdV; manuscript review: NPvE, EC and PBO. All authors read and approved the final version of the manuscript. | PMC10033566 | ||
Funding | This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. | PMC10033566 | ||
Availability of data and material | The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to their containing information that could compromise the privacy of research participants. | PMC10033566 | ||
Code availability | Not applicable. | PMC10033566 | ||
Declarations | PMC10033566 | |||
Conflict of interest | Dr. Nielka van Erp declares the following financial activities outside the submitted work: received grants for investigator driven studies from Astellas and Janssen-Cilag and educational grants for lectures from Sanofi and Bayer. The other authors declare that they have no conflicts of interest. | PMC10033566 | ||
Ethics approval | This clinical trial was approved by the institutional ethics committee Arnhem-Nijmegen (Nijmegen) and was compliant with the Declaration of Helsinki. | PMC10033566 | ||
Consent to participate | All patients provided written informed consent before entering the study. | PMC10033566 | ||
Consent for publication | Not applicable. | PMC10033566 | ||
References | PMC10033566 |
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