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Funding | Esophageal Cancer | ESOPHAGEAL CANCER | This study was supported by the Science and Technology Program of Guangzhou, China (202103000064) and the Science and Technology Project of Guangdong Esophageal Cancer Research Institute (M202017). | PMC10290378 |
Availability of data and materials | Data are available upon reasonable request. All data relevant to this study are included in the article or uploaded as Supplemental information. | PMC10290378 |
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Declarations | PMC10290378 |
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Ethics approval and consent to participate | Cancer | CANCER | This study was approved by the institutional review boards at Sun Yat-sen University Cancer Center (B2019-226-01) and all patients provided written informed consents. | PMC10290378 |
Consent for publication | Not applicable. | PMC10290378 |
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Competing interests | Yating Zheng, Ting Bei, Mengli Huang, and Yuezong Bai declare that they are employees of 3D Medicines Inc. | PMC10290378 |
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References | PMC10290378 |
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Materials and Methods: | Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5–7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. | PMC9810348 |
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Results: | erectile dysfunction | ERECTILE DYSFUNCTION | We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared with baseline. Men in the iTind arm without erectile dysfunction at baseline showed an improvement in total IIEF score of +6.07 ± 21.17 points ( | PMC9810348 |
Conclusion: | prostate | PROSTATE | No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function.Clinicaltrials.gov: NCT02506465 | PMC9810348 |
Introduction | lower urinary tract symptoms, LUTS | SECONDARY, BENIGN PROSTATIC HYPERPLASIA (BPH), BPH, UROLOGICAL DISEASES, DISEASES | Benign prostatic hyperplasia (BPH), one of the most common diseases affecting men as they age, often causes lower urinary tract symptoms (LUTS) that can negatively affect daily activities and quality of life (QoL). The impact of BPH is significant, far exceeding other urological diseases, and is forecasted to continue to rise.The sexual side effects associated with both pharmacological and surgical treatment options contribute significantly to the undertreatment of men with bothersome BPH. Since sexual health is a highly important aspect of QoL, especially among younger men or men who are currently sexually active, there is a desire to preserve their sexual function.There are three novel, U.S. Food and Drug Administration (FDA)-approved MISTs for LUTS secondary to BPH. They include the prostatic urethral lift (UroLift | PMC9810348 |
Materials and Methods | PMC9810348 |
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Study protocol and objectives | Medication-naive, cystolithiasis, prostate, hematuria, prostate or bladder cancer | RESPIRATORY DISORDERS, RECURRENT URINARY TRACT INFECTION, DIABETES MELLITUS, PROSTATE, HEMATURIA, CARDIAC DISEASE, PROSTATE, NEUROGENIC BLADDER | Details surrounding this study design have previously been reported.Subjects enrolled included: men ≥50 years, IPSS (International Prostate Symptoms Score) of ≥10, peak urinary flow rate of ≤12 mL/s with a 125 mL voided volume, prostate volume between 25 and 75 cc, and normal urinalysis, complete blood count, and biochemistry. Excluded patients had a postvoid residual volume (PVR) >250 mL, obstructive median lobe (OML) on ultrasound, prostate-specific antigen (PSA) >10 ng/mL or free PSA <25% without negative prostate biopsy, prostate or bladder cancer, previous prostate surgery, neurogenic bladder and/or sphincter abnormalities, recent hematuria or cystolithiasis, current urinary tract infection, decreased renal function, severe respiratory disorders, cardiac disease, immunosuppression, current antithrombotic and antiplatelet treatment, and uncontrolled diabetes mellitus. Cystoscopy was not mandatory during screening, but cystoscopy was used during placement of the device and an intraoperative exclusion criterion of OML existed.Baseline medical history, BPH-related medications, uroflowmetry, IPSS, PVR, and completion of questionnaires regarding QoL, ED, and EjD was collected at baseline, 6 weeks, 3 months, and 12 months postoperatively. All patients on BPH-related medications started a wash-out period before implantation: 1 month for alpha-blockers and 6 months for 5-ARIs. Medication-naive patients seeking treatment refused medication in preference for a MIST. Patients were unblinded at 3 months. | PMC9810348 |
iTind procedure | prostate | PROSTATE | As previously described, the iTind device comprises three elongated, intertwined nitinol struts at the 12, 5, and 7 o'clock positions, an antimigration anchoring leaflet at 6 o'clock, and a polyester retrieval suture for easy device removal.The device is implanted for 5–7 days, during which it expands and exerts radial force, creating deep ischemic incisions and a remodeling on the prostate tissue at the bladder neck and anterior prostatic fossa. The iTind is deployed under direct visualization in an ambulatory procedure using a rigid cystoscopy. The device is removed through either a rigid cystoscope or an open-ended 22F Foley catheter with topical anesthesia. Both implantation and removal can be done under local, intravenous, or general anesthesia at the discretion of the performing physician. Catheterization is not required following either implantation or removal. | PMC9810348 |
Sham procedure | The sham control was the insertion and removal of an 18F silicon Foley catheter to simulate both the implantation and retrieval procedures. Throughout the procedure, the surgeon gave verbal description as if deploying the iTind device, after which the catheter was removed. A similar protocol was followed for the sham device retrieval. Although the iTind device is deployed through a rigid cystoscope, a Foley catheter was used to minimize the risk of procedure-related morbidity as suggested by the FDA. Subjects in both the device and control groups were draped to prevent them from seeing the treating physician and the device. | PMC9810348 |
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Questionnaires | SIDE EFFECT | We evaluated sexual side effect profiles using validated patient-reported outcomes. The Sexual Health Inventory for Men (SHIM) is a validated tool for screening and diagnosis of ED and severity of ED in clinical practice and research.The total version of the IIEF-15 is a validated self-report questionnaire for measuring ED in clinical trials and is widely used. The minimally clinically important difference, the smallest difference in a score that a patient would perceive as beneficial, has been defined as a change of score of 4 points. | PMC9810348 |
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Statistical methodology | mild/moderate, prostate | PROSTATE | Subjects were randomized in 2:1 ratio to either iTind or control (sham) group, respectively. Randomization was conducted using permuted blocks stratified by center by using a central electronic data program.Subjects were divided into subgroups according to age (three subgroups: 50–60, 61–70, >70), prostate volume (three subgroups: ≤40, 41–60, >60), and baseline total SHIM score (five subgroups: no function, severe ED, moderate, mild/moderate, mild, and no ED). Within each subgroup, change from baseline in total IIEF score was compared between iTind and sham at 3 months visit, and within the iTind group at 12 months visit.Differences between the groups at 3 months were analyzed using a mixed linear model with group, baseline total IIEF score, and subgroup as predictors. Differences within the iTind group at 12 months were analyzed using a mixed linear model with baseline total IIEF score and subgroup as predictors. Only patients who arrived at 3 or 12 months visits were included in the analysis. Additionally, any patients that required BPH-related medications during the follow-up period were excluded from the analysis.Statistical analysis was done using SAS 9.4 (SAS Institute, Inc., Cary, NC, USA). Statistical significance was accepted at | PMC9810348 |
Results | PMC9810348 |
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Study population | Prostate | PROSTATE | We studied 185 men with a mean age of 61.1 ± 6.5 years who were randomized 2:1 to either iTind (Baseline DemographicsBaseline demographics are presented for both iTIND and sham groups.BMI = body mass index; IIEF = International Index of Erectile Function; IPSS = International Prostate Symptom Score; iTIND = temporarily implanted nitinol device; PSA = prostate-specific antigen; PVR = postvoid residual volume; QoL = quality of life; SD = standard deviation; SHIM = Sexual Health Inventory for Men. | PMC9810348 |
Sexual health inventory for men | There were no differences in the total SHIM score between iTind and sham at 3 months (13.13 ± 7.88 | PMC9810348 |
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International Index of Erectile Function | prostate | PROSTATE | There were no differences in the total IIEF score between iTind and sham at 3 months (41.47 ± 22.56 When stratifying by prostate volume, men with smaller prostates (<40 mL), within the iTind arm at 12 months had a change in total IIEF of +4.95 (clinically meaningful), although it was not significant (Stratifying by baseline SHIM scores, men treated with iTind who had no ED at baseline showed clinically and statistically significant improvement at 12 months of follow-up in total IIEF score of +6.07 ± 21.17 (Changes in total IIEF scores from baseline within the iTind subgroup, baseline total SHIM >21. *Statistically significant value ( | PMC9810348 |
Ejaculatory dysfunction | There were no differences in IIEF question 9 between iTind and sham at 3 months (+0.09 Changes IIEF question 9 (ejaculation upon orgasm) scores from baseline within the iTind subgroup, baseline total SHIM >21. *Statistically significant value ( | PMC9810348 |
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Discussion | LUTS, hematospermia, prostate | ANEJACULATION, ADVERSE EVENTS, PROSTATE, SECONDARY, BPH | iTind was an effective treatment for LUTS secondary to BPH while preserving sexual function regardless of age, prostate volume, or baseline ED status. ED, as measured by both total SHIM and IIEF scores and when stratifying by age, prostate volume, or baseline ED status, did not change significantly over the 12-month study period. This is in line with 6-month data from a prospective study showing no ED in men treated with iTind.Moreover, iTind was shown to not cause EjD in men, regardless of age, prostate volume, or baseline ED status. Additionally, men without baseline ED had improvement of 21.5% when looking at IIEF question 9 to evaluate for EjD. Importantly, we had no patient-reported ejaculatory adverse events such as anejaculation, decreased ejaculatory volume, painful ejaculation, or hematospermia. Rezum, on the other hand, reported 2.9% anejaculation compared with 0% in their sham arm.Additionally, men who have no baseline ED (SHIM >21) also showed clinically significant improvement of IIEF at 12 months as compared with their baseline (6.07 ± 21.17, Our study has several limitations. First, we experienced loss of follow-up between the baseline groups at 3 months in 29% of iTind patients and 30% of the sham arm. Even though we experienced loss to follow-up, a matched dropout rate between the iTind and sham arm indicates it is likely not a procedure-related drop off. Another important limitation to note is that this study was originally designed to evaluate the change of LUTS following iTind | PMC9810348 |
Conclusions | prostate | PROSTATE | iTind can maintain sexual and ejaculatory function regardless of a man's age, prostate volume, and baseline sexual function. | PMC9810348 |
Authors' Contributions | C.H. | Conceptualization: D.E. and B.C. Data curation: D.E., B.C., and M.N.A. Formal analysis: D.E., B.C., M.N.A, and S.M.D. Funding acquisition: D.E. and B.C. Investigation: D.E., M.N.A, N.S., M.G., J.M., S.P., C.H., W.T, A.K., R.G., A.K., J.S., E.G., I.G., L.M.T., J.K., and B.C. Methodology: D.E., M.N.A, N.S., M.G., J.M., S.P., C.H., W.T., A.K., R.G., A.K., J.S., E.G., I.G., L.M.T, J.K., and B.C. Project administration: D.E. and B.C. Resources: D.E. and B.C. Software: D.E. and B.C. Supervision: D.E. and B.C. Validation: D.E. and B.C. Visualization: D.E. and B.C. Writing—original draft: D.E., M.N.A, N.S., M.G., J.M., S.P., C.H., W.T., A.K., R.G., A.K., J.S., E.G., I.G., L.M.T., J.K., S.M.D., and B.C. Writing—review and editing: D.E., M.N.A, N.S., M.G., J.M., S.P., C.H., WT., A.K., R.G., A.K., J.S., E.G., I.G., L.M.T., J.K., S.M.D., and B.C. | PMC9810348 |
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Author Disclosure Statement | D.E. is on the medical advisory board. B.C. is a consultant for Medi-Tate Ltd., Olympus, Boston Scientific, and Medeon Bio. The other authors have no conflicts of interest. | PMC9810348 |
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Consent to Participate | Informed consent was obtained from all individual participants included in the study. | PMC9810348 |
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Consent for Publication | The authors affirm that human research participants provided informed consent for publication. | PMC9810348 |
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Funding Information | Medi-Tate Ltd. (acquired by Olympus) sponsored this study. | PMC9810348 |
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References | PMC9810348 |
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Abbreviations Used | devicelower urinary tract symptomsminimally, Comorbidity | PROSTATE, PROSTATE | 5-alpha-reductase inhibitorbody mass indexbenign prostatic hyperplasiaCharlson Comorbidity Indexerectile dysfunctionejaculatory dysfunction U.S. Food and Drug AdministrationInternational Index of Erectile FunctionInternational Prostate Symptoms Scoretemporarily implanted nitinol devicelower urinary tract symptomsminimally invasive surgical techniqueMale Sexual Health Questionnaireobstructive median lobepeak urinary flow rateprostate-specific antigenpostvoid residual volumemaximum flow ratequality of lifestandard deviationSexual Health Inventory for Mentransurethral resection of the prostate | PMC9810348 |
Background | Food systems highly contribute to anthropogenic greenhouse gas emissions and shifting towards more environmentally friendly diets is urgently needed. Enabling consumers to compare the environmental impact of food products at point-of-purchase with front-of-pack labelling could be a promising strategy to trigger more environmentally friendly food choices. This strategy remained to be tested. | PMC9881283 |
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Methods | The effect of a new traffic-light front-of-pack environmental label on food choices was tested in a 2-arm randomised controlled trial in a virtual reality supermarket. Participants ( | PMC9881283 |
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Results | In the everyday meal scenario, the environmental impact of meals was lower in the label condition than in the no label condition (-0.17 ± 0.07 mPt/kg, | PMC9881283 |
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Conclusions | Implementing a front-of-pack environmental label on food products in real supermarkets could increase awareness of the environmental impact of food and contribute to drive more environmentally friendly food choices. | PMC9881283 |
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Trial registration | The study protocol was pre-registered prior to data collection at Clinicaltrials.gov (NCT04909372). | PMC9881283 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12966-023-01410-8. | PMC9881283 |
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Keywords | PMC9881283 |
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Background | Food systems play a major role in anthropogenic greenhouse gas emissions (GHGE) [In this context, highlighting the need for a global public awareness of the environmental impacts of food products, the French government has set up an interdisciplinary committee to assess the feasibility and efficiency of environmental labelling on food products [A recent systematic review by Potter and colleagues (2021) provided promising evidence regarding the ability of carbon footprint labels or other ecolabels (e.g., organic, sustainable agricultural practices) to promote more environmentally friendly food choices [Another limitation of previous studies is their designs that may have increased participants’ attention to environment labels compared to real-life [The present study was a randomised controlled trial with two experimental arms (with vs. without environmental labelling) conducted in a virtual reality supermarket that included a large and diverse range of food products that could be part of a main meal. We aimed to develop a new traffic-light front-of-pack environmental label with a design based on state-of-the-art evidence [ | PMC9881283 |
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Methods | PMC9881283 |
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Data collection | The study protocol was pre-registered prior to data collection at Clinicaltrials.gov (NCT04909372). Participants were recruited using the PanelSens database declared to the relevant French authority ( | PMC9881283 |
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Study design | RECRUITMENT | This study was a randomised controlled trial in a virtual reality supermarket with two experimental arms: (1) no front-of-pack environmental labelling (no label condition) and (2) front-of-pack environmental labelling (environmental label condition). A 1:1 2-block randomisation sequence (for male and female) was generated before recruitment using the Random Allocation Software [Experimental design for the virtual reality tasks performed by the participants | PMC9881283 |
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Procedure | Individual experimental sessions lasted on average 35 min (min: 25 min, max: 45 min). After participants gave their written informed consent to take part in the experiment, they sat on a chair and were equipped with a virtual reality (VR) headset by a research assistant. Participants were given instructions regarding the VR headset and hand controller (with a joystick and selection buttons). Pictures of the virtual environment and of the VR headset and hand controller are presented in supplementary file (Figure S | PMC9881283 |
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Virtual supermarket environment | PMC9881283 |
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Virtual reality functionalities | The virtual supermarket environment was inspired by recent work by Melendrez-Ruiz and colleagues (2021) [ | PMC9881283 |
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Food products | Based on the results of a recent study in a virtual reality supermarket using similar food choice tasks [ | PMC9881283 |
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Recorded data | Food choices were recorded for each task within the VR headset. Each participant had to rate the eight food products selected for their level of familiarity (frequency of consumption of a similar product, ranging from 1 = “never” to 5 = “very often”) and liking (continuous sale, ranging from 1 = “I do not like [the food product] at all” to 10 = “I like [the food product] very much”). | PMC9881283 |
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Environmental label | PMC9881283 |
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Calculation of the environmental score | The environmental impact, measured by the Environmental Footprint single score (EF single score), of the 96 foods items included in the virtual supermarket was retrieved from the open-access Agribalyse database [ | PMC9881283 |
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Design of the environmental label | MAY | As there was neither an existing environmental label nor a consensus on an environmental label design for food products in France at the time of the present study (May 2021), we designed a new label. The ideal carbon label proposed by Carrero et al., 2021 is a traffic-light label. It has been shown that green is often seen as a validation and a positive colour whereas red is associated to negative aspects and danger [Design of the traffic-light front-of-pack environmental labels | PMC9881283 |
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Additional questionnaires | Participants were asked to complete questionnaires on Qualtrics survey platform ( | PMC9881283 |
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Outcomes | PMC9881283 |
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Primary outcome | The primary outcome was the environmental impact (EF single score in mPt per kg of product) of the food products selected in each task. The environmental impact of the composed meal for Task 1 was calculated as the mean of the EF single scores per kg of the three selected meal components in each scenario. The environmental impact of the ready-to-eat meal for Task 2 of each scenario was defined as the EF single score per kg of the selected product. Other indicators were calculated in the same manner: greenhouse gas emissions (GHGE), ozone depletion and particulate matter. | PMC9881283 |
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Secondary outcomes | The nutritional quality of the food products selected was assessed by the FSA score developed by the British Food Standards Agency [ | PMC9881283 |
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Meal types | Meals types were defined based on the source of protein that was included in a meal: meat-meals (further distinction between beef/lamb meals and poultry/pork meals), fish meals and vegetarian meals (further distinction between lacto-ovo meals or plant-based meals). In total, there were three main meal types (meat-based, fish-based and vegetarian meals) and five sub-meal types (beef or lamb-based, poultry or pork-based, fish-based, lacto-ovo and plant-based meals). We ranked the sources of protein on the basis of their environmental impact: beef or lamb > poultry or pork > fish > dairy or egg > plant-sourced protein [ | PMC9881283 |
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Statistical analyses | SECONDARY | We followed an analysis plan pre-registered on Open Science Framework (EF single scores were standardised within the 66 meal components and the 30 ready-to-eat meals shelves because the scores of food products composing each shelf had different distributions (average environmental impact for the meal components shelf: 0.61 ± 0.86, ready-to-eat meals shelf: 0.54 ± 0.39). The standardisation allowed the comparison of the two tasks in the same statistical model. To examine the effect of the environmental label on the environmental impact of food choices, the primary analysis consisted in a mixed model that tested the effects of labelling (categorical variable: environmental label or no label), food choice task (categorical variable: choice of a composed meal or a ready-to-eat meal), labelling*food choice task interaction on standardised EF single scores (everyday meal scenario only), with random effect of participants to account for correlation between repeated measures. Parameters estimates were calculated after removing non-significant interaction.In sensitivity analyses, we tested whether the results from the primary mixed model differed: 1/ after excluding aim-guessers, 2/ after excluding outliers on the primary outcome, 3/ after adjusting for age, gender, highest education level and BMI and 4/ after replacing standardised EF single scores by standardised GHGEs, ozone depletion and particulate matter scores.To examine existing knowledge and additional information provided by the environmental label, the main effect of food choice scenario (categorical variable: everyday meal scenario or environmentally friendly meal scenario), as well as labelling*scenario and scenario*food choice task interactions, were added to the primary mixed model presented above. Pairwise post-hoc comparisons were conducted to compare the environmental impact of food choice between the everyday meal and environmentally friendly meal scenario in participants with no label (i.e., highlighting existing knowledge) and to compare the environmental impact of food choice between no label and environmental label condition in the environmentally friendly meal scenario (i.e., highlighting additional information provided by the label). Parameters estimates were calculated after removing non-significant interactions.As secondary analyses we examined the effect of the environmental label on secondary outcomes with mixed models testing the effect of labelling, food choice task and labelling*food choice task interaction on nutritional quality, price per kcal, liking and familiarity (everyday meal scenario only), with random effect of participants to account for correlation between repeated measures.As exploratory analyses, Chi-squared tests were performed to test whether labelling condition was associated to meal types (beef or lamb-based meals, poultry or pork-based meals, fish-based meals, dairy or egg-based meals and plant-based meals) in the everyday meal scenario for Task 1 (composed meal) and Task 2 (ready-to-eat meal) separately. | PMC9881283 |
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Sample size | We powered the primary analyses in order to detect a d = 0.50 effect size of labelling condition on EF single scores based on the results of a previous randomised controlled trial that tested the effect of an environmental label on canned soup choices [ | PMC9881283 |
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Results | PMC9881283 |
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Participants | A total of 435 participants were assessed for eligibility and data from 132 who completed the study were analysed (Fig. CONSORT flow diagram | PMC9881283 |
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Effect of labelling on environmental impact of everyday meals | The participants were first asked to choose food products for an everyday main meal, in two distinct tasks in the virtual reality supermarket. During the first task, they selected three meal components for a composed meal and during the second task, they selected a ready-to-eat meal. Participants randomised in the environmental label condition (Mean (± SEM) of EF single scores for food products selection in the two tasks combined (choice of a composed meal and a ready-to-eat meal), in the two food choice scenarios (everyday meal or environmentally friendly meal), with or without environmental label. * For descriptive purpose, Fig. Food choices based on the five environmental impact scores (from A to E) for meal components and ready-to-eat meals, in the everyday meal scenario, with or without environmental label | PMC9881283 |
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Effect of labelling on the environmental impact of environmentally friendly meals | After having selected food products for an everyday meal, all the participants were asked to choose food products for an environmentally friendly meal. In a linear mixed model, we found a main effect of the labelling condition (-0.18, t(394) = -3.44, | PMC9881283 |
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Meal types selection | We showed that participants in the environmental labelling condition selected everyday meals of lower environmental impact than participants in the no label condition. We further investigated whether the cross-category nature of the environmental label led to a lower environmental impact of food choices through between-categories substitutions. In exploratory analyses (not pre-registered), we thus compared everyday meal choices classified into three meal types: meat-based meals (with a further distinction between beef/lamb and poultry/pork), fish-based meals and vegetarian meals (with a further distinction between lacto-ovo vegetarian meals and plant-based meals) categories.Meal types chosen for the composed meals were significantly influenced by the label (Chi-2 = 7.67, Meal types choices for the composed meals and ready-to-eat meals in the everyday meal scenario, with or without environmental label. (Chi-2 test * | PMC9881283 |
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Nutritional quality, energy cost, familiarity and liking | In a linear mixed model, there were no significant effects of the environmental label on nutritional quality (-0.12, t(131) = -1.29, | PMC9881283 |
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Perception of the label and virtual reality experience | Participants in the labelling condition were asked whether they noticed and understood the environmental label on the food products when they were in the virtual supermarket. Results showed that 89% declared having seen the environmental label and 96% that the environmental label depicted the environmental impact of the food products (see supplementary materials, Table S | PMC9881283 |
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Discussion | TRANSITION | For the first time, the effectiveness of traffic-light front-of-pack environmental labelling was tested in a randomised controlled trial conducted in a virtual reality supermarket, including a large and diverse range of food products. We demonstrated that the environmental label significantly reduced the environmental impact of food choices at no nutritional, financial or hedonic cost. In the present study, we developed a cross-category environmental label which has been highlighted as a promising tool to substantially reduce the environmental impact of diets [As discussed in a recent review on the effect of environmental labels and based on the COM-B (Capacity Opportunity Motivation Behaviour) framework for understanding behaviour [Application of the COM-B framework to a cross-category traffic-light front-of-pack environmental labelIn the context of a national experimentation phase of environmental labelling in the food sector (2020–2021) coordinated by the French Agency for Ecological Transition (ADEME), the results of the present study contributed to inform the development and future implementation of an environmental labelling system for all food products in France. Numerous stakeholders and experts contributed to this experimentation phase providing guidelines on six aspects 1/ environmental issues that should be considered, 2/ objectives that should be targeted, 3/ data that are needed, 4/ methods for assessing environmental impacts, 5/ environmental scores that should be chosen, 6/ label format that should be proposed [ | PMC9881283 |
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Strengths and limitations | This study was a pre-registered randomised controlled trial in a realistic food choice environment and the first to test the effect of an environmental label on food choices in a virtual supermarket. Using questionnaires, we confirmed that the label had been seen, understood and used by a majority of the participants in the labelling condition.Our study is unique compared to the previous studies that have tested environmental labelling in online supermarkets as consumers may not have the same shopping behaviours in (virtual) stores compared to online. In particular, it has been shown that contrary to online food environments where factual information is more important, sensory attributes are stronger drivers of in-store food choices [We could only include a limited number of food items in the virtual supermarket. We decided to only include items that could be part of a main dish because meat-based products are the food items with the worst impact on the environment and are usually consumed as part of main dishes [In order to study cross-category substitutions we only included one version of each food product and therefore only one brand to choose from. Products with more familiar brands may have been more chosen by the participants. We observed no difference in familiarity and liking of food products between the two labelling conditions suggesting that the participants selected food products they would have been likely to choose in both conditions, they thus reshaped their food choices within a selection of foods that they liked and were familiar to. | PMC9881283 |
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Conclusions | In the present study, we developed a new traffic-light front-of-pack environmental label based on a score that differentiated food categories. This label was highly noticed, well understood and provided new information that helped the participants to identify the food products of lower environmental impact. Using VR technology that mimicked how an environmental labelling scheme would be likely implemented in real-world supermarkets, we observed a reduction of the environmental impact of food choices in the presence of the environmental label. We thus highlighted that environmental labelling could be a useful tool to shape sustainable dietary patterns at a population level by triggering substitutions across food categories, notably from meat-based to plant-based food products. We also confirmed that VR technology was an effective tool for monitoring individual decision-making behaviours at the point-of-choice in the context of a randomised controlled trial which may be of great interest for future research in behavioural nutrition. Altogether, the results of this study support the idea that environmental labelling could contribute to a global raise in public awareness regarding the environmental impacts of food products across food categories. | PMC9881283 |
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Acknowledgements | RECRUITMENT | We thank the ChemoSens platform for the help with the recruitment of participants, in particular C. Martin and F. Durey. We thank V. Feyen and L. Ben Sussan for their help with data collection and K. Pagnat for his help with the development of the virtual supermarket. We also thank L-G. Soler and L. Muller for their valuable inputs on the protocol. | PMC9881283 |
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Authors’ contributions | LA: conceptualization, investigation, formal analysis, writing – original draft; SC: conceptualization, writing – review and editing; GA: conceptualization, writing – review and editing; IG: methodology, writing – review and editing; JCC: methodology, software, data curation, writing – review and editing; SN: conceptualization, writing – review and editing; LM: funding acquisition, conceptualization, investigation, writing – review and editing. The authors read and approved the final manuscript. | PMC9881283 |
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Funding | This work was supported by grants from ADEME (2103D0040-A, ADAE grant to LM), the Conseil Régional Bourgogne, Franche-Comte (PARI grant) and the FEDER (European Funding for Regional Economic Development). The funders had no role in planning, conducting, or interpreting the study. | PMC9881283 |
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Availability of data and materials | The datasets analysed during the current study will be made available on the Open Science Framework project page at the time of publication ( | PMC9881283 |
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Declarations | PMC9881283 |
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Ethics approval and consent to participate | The study was approved by the CEEI-IRB ethical committee (N°21–780, Institutional Review Board INSERM). Informed consent was obtained from all the participants before they started the study. | PMC9881283 |
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Consent for publication | Not applicable. | PMC9881283 |
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Competing interests | The authors declare that they have no competing interest. | PMC9881283 |
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References | PMC9881283 |
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Background | cancer, gastric cancer | CANCER, COLORECTAL CANCER, ADENOCARCINOMA, GASTRIC CANCER | Trifluridine/tipiracil (FTD/TPI) prolongs survival in the third- or later-line treatment for advanced gastric cancer (GC), esophagogastric junction (EGJ) adenocarcinoma, and colorectal cancer. While single-arm phase II trials showed promising outcomes of FTD/TPI plus ramucirumab (RAM) as third- or later-line treatments for advanced GC or EGJ cancer, there have been no clinical trials to directly compare FTD/TPI plus RAM with FTD/TPI monotherapy. Therefore, we have started a randomised phase II trial to evaluate the efficacy and safety of FTD/TPI plus RAM compared with FTD/TPI monotherapy as third- or later-line treatments in patients with advanced GC and EGJ adenocarcinoma. | PMC10403909 |
Methods | ADENOCARCINOMA | This RETREVE trial (WJOG15822G) is a prospective, open-label, randomised, multicentre phase II trial comparing FTD/TPI plus RAM versus FTD/TPI monotherapy in a third- or later-line setting. Eligibility criteria include age of > 20 years; performance status of 0 or 1; unresectable or recurrent gastric or EGJ adenocarcinoma; confirmed HER2 status; refractory or intolerant to fluoropyrimidine, taxane or irinotecan; refractory to RAM (not intolerant); and at least a measurable lesion per RECIST 1.1. FTD/TPI (35 mg/m | PMC10403909 |
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Discussion | EGJ cancer | DISEASE PROGRESSION | This study will clarify the additional effect of RAM continuation beyond disease progression on FTD/TPI in the third- or later-line setting for patients with advanced GC or EGJ cancer. | PMC10403909 |
Trial registration | jRCTs041220120. | PMC10403909 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12885-023-11199-1. | PMC10403909 |
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Keywords | PMC10403909 |
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Background | Gastric cancer, cancer, unresectable or recurrent gastric cancer, tumour, adenocarcinoma | GASTRIC CANCER, CANCER, TUMOUR, ADENOCARCINOMA | Gastric cancer (GC) is the fifth most common and fourth most deadly cancer worldwide [As later-line treatment in patients with advanced gastric and EGJ adenocarcinoma, monotherapy with trifluridine/tipiracil (FTD/TPI), irinotecan, and nivolumab are recommended in the Japanese treatment guideline, regardless of HER2 status [FTD/TPI is an oral cytotoxic chemotherapeutic agent comprising trifluridine, an antineoplastic thymidine analog, and tipiracil, which prevents trifluridine degradation. The TAGS, an international joint phase III study to examine the prolongation of overall survival (OS) of FTD/TPI over placebo in patients with unresectable or recurrent gastric cancer refractory to standard treatment, showed that FTD/TPI monotherapy was significantly superior to the placebo (hazard ratio [HR]: 0.69, 95% confidential interval [CI]: 0.56–0.85, one-sided Recently, combination therapy with FTD/TPI and angiogenesis inhibitors for pre-treated patients with gastric or EGJ adenocarcinoma has been implemented globally. In Japan, a single-arm phase II study of FTD/TPI plus ramucirumab (RAM) showed promising outcomes in terms of tumour response, PFS, associated with the feasible safety profile [ | PMC10403909 |
Methods/design | PMC10403909 |
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Objectives | cancer | CANCER, SECONDARY | The objective of this RETRIEVE study (WJOG15822G) is to evaluate the efficacy and safety of FTD/TPI plus RAM as a third- or later-line treatment for patients with unresectable or recurrent GC or EGJ cancer, compared with FTD/TPI monotherapy. The primary endpoint is PFS and the secondary endpoints are OS, ORR, DCR, and safety. | PMC10403909 |
Study design | arrhythmia, multiple cancer, inflammatory bowel disease, diabetes mellitus, autoimmune diseases, Hypersensitivity, Unstable angina, allergy, non-haematological toxicity, arrhythmias, gastrointestinal obstruction, thrombosis, ascites, mental illness, pulmonary artery thrombosis, HBV infection, cancer, vasculitis, gastrointestinal bleeding, fracture, hair loss, dysgeusia, cancer / multiple cancer, unrecovered trauma, adrenal hypofunction, infection, gastric adenocarcinoma, myocardial infarction, gastrointestinal perforation, fistula, active gastric ulcer, peripheral neuropathy | PLEURAL EFFUSION, RECURRENCE, ARRHYTHMIA, MULTIPLE CANCER, INFLAMMATORY BOWEL DISEASE, DIABETES MELLITUS, AUTOIMMUNE DISEASES, HYPERSENSITIVITY, UNSTABLE ANGINA, ALLERGY, WEST, ONCOLOGY, ARRHYTHMIAS, GASTROINTESTINAL OBSTRUCTION, CEREBRAL INFARCTION, THROMBOSIS, ASCITES, DEEP VEIN THROMBOSIS, CANCER, ADVERSE EVENT, VASCULITIS, GASTROINTESTINAL BLEEDING, HAIR LOSS, ADVERSE EVENTS, HIV INFECTION, ADRENAL HYPOFUNCTION, INFECTION, PULMONARY ARTERY THROMBOSIS, TUMOR METASTASIS, CROHN'S DISEASE, HEART FAILURE, GASTRIC ADENOCARCINOMA, BRAIN METASTASIS, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, IMMUNE DEFICIENCY, GASTROINTESTINAL PERFORATION, PERIPHERAL NEUROPATHY, ARTERIAL THROMBOSIS | This is a prospective, open-label, randomised, multicentre phase II study, conducted in 47 centres of the West Japan Oncology Group (WJOG) in Japan (Fig. Study schema of RETRIEVE studyKey eligibility criteria for the RETRIEVE study1) Age of 20 years or above2) ECOG PS of 0 or 13) Histologically diagnosed as gastric adenocarcinoma or EGJ4) Unresectable progression or recurrence confirmed by CT scan5) Prior use of fluoropyrimidine, taxanes or irinotecan (patients are eligible even if they have used both drugs), ramucirumab (eligible only for refractory cases)6) One or more measurable lesions by RECIST version 1.17) HER2 test has been performed before registration8)) Expected to survive for 3 months or more9) Adequate organ and bone marrow function10) Written consent has been obtained1) Active double cancer (simultaneous double cancer / multiple cancer and metachronous double cancer or multiple cancer with a disease-free period of 2 years or less)2) Difficulty with oral intake. Specifically, cases that require daily infusion for purposes of nutrition and water intake3) Pre-treatment including FTD/TPI in the past4) Hypersensitivity to the drugs used in this study5) Past history of major surgery (general anaesthesia required) within 4 weeks and/or radiation therapy covering the abdomen within 2 weeks before registration6) Cases with severe pleural effusion7) Cases with severe ascites or a history of palliative ascites puncture within 2 weeks before registration8) Cases with brain metastasis and tumor metastasis to the central nervous system9) Adverse events (non-haematological toxicity) of poorly controlled Grade 2 or higher (CTCAE v5.0) remain at the time of registration (patients with hair loss, dysgeusia, pigmentation, or peripheral neuropathy may still be registered even if Grade 2 or higher)10) Local or systemic active infection that requires treatment11) Uncontrolled hypertension or diabetes mellitus despite adequate treatment12) Unstable angina within 4 weeks prior to enrolment, uncontrolled heart failure, arrhythmia requiring treatment; excluding arrhythmias that are not clinically problematic14) Serious haemorrhagic disorders or vasculitis. Cases with significant gastrointestinal bleeding episodes (Grade 3 or higher) within 12 weeks prior to enrolment15) Past history of gastrointestinal perforation or fistula within 24 weeks prior to registration. Past history of gastrointestinal obstruction or inflammatory bowel disease such as Crohn's disease. However, regarding gastrointestinal obstruction, cases in which colostomy or bypass surgery has been performed in the past and oral intake is sufficiently possible are included16) Past history of unrecovered trauma, active gastric ulcer, or fracture within 4 weeks prior to enrolment17) Past history of arterial thrombosis (including myocardial infarction and cerebral infarction) within 24 weeks before registration18) History of deep vein thrombosis or pulmonary artery thrombosis (excluding catheter thrombosis and superficial thrombosis) within 12 weeks before registration. However, anticoagulation for the prevention of thrombosis is allowed if coagulation function has been stable for at least 12 weeks prior to enrolment (PT-INR ≤ institutional maximum × 1.5)19) Immune deficiency (such as HIV infection), autoimmune diseases with administration of systemic steroids20) Patients taking antiplatelet drugs. Low doses of aspirin (less than 325 mg/day) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted21) Continuous use of systemic steroids (excluding contrast agent allergy prophylaxis, pre-medication of anti-cancer agents, hydrocortisone replacement therapy for adrenal hypofunction of immune-related adverse events) and immunosuppressive agents23) HBs-Ag is positive. However, patients can still be registered if HBV infection is controlled by a nucleic acid analogue preparation and no presence of HBV-DNA is confirmed24) Pregnant women, lactating women, women who may be pregnant or who are not willing to use contraception25) Difficulty enrolling in this study due to a clinical problem involving mental illness | PMC10403909 |
Procedures | FTD/TPI (35 mg/mThree dose reduction levels were set: 35 (starting level), 30 (level -1), 25 (level -2), and 20 mg/m | PMC10403909 |
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Assessment | Tumour | ADVERSE EVENTS, TUMOUR | Tumour was assessed using CT scan of the chest, abdomen, and pelvis within 2 weeks before randomisation and every 8 weeks after randomisation until discontinuation of the protocol treatment. Patients are required to visit the hospital every 2 weeks to check their physical condition and adverse events during the protocol treatment. Laboratory tests are performed within 2 weeks before randomisation and repeated every 2 weeks after randomisation until discontinuation of the protocol treatment. | PMC10403909 |
Evaluation of outcomes | death, Tumour, Cancer | DISEASE PROGRESSION, ADVERSE EVENT, TUMOUR, DISEASE, ADVERSE EVENT, CANCER | PFS is defined as the time from randomisation to disease progression or death from any cause. OS is defined as the time from randomisation to death from any cause. Tumour response is assessed according to the RECIST (version 1.1). Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment. DCR is defined as the proportion of patients with a complete response, partial response, or stable disease. The severity of each adverse event is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). | PMC10403909 |
Sample size calculation and statistical analysis | SECONDARY | The statistical hypothesis is set with reference to the PFS of previous clinical studies in advanced GC. The PFS rate at 4 months was reported as approximately 27% in the FTD/TPI arm of the TAGS trial [The analyses of the primary and secondary efficacy endpoints are planned to be performed in the full analysis set, and additional analysis is planned in the intention-to-treat population and in the per protocol if necessary. The safety analysis is planned to be conducted in the safety analysis population.Patient characteristics will be compared using Pearson’s | PMC10403909 |
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Study organization | The WJOG is responsible for project management during the trial. The tasks of the WJOG include the coordination of investigator meetings, monitoring, data management, and audits. Central monitoring but not onsite monitoring will be performed regularly according to the monitoring procedures which are adapted to study-specific patient risks, and compliance to the WJOG group rules will be audited throughout study. | PMC10403909 |
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Data management, control of data consistency, and quality control | To protect patient privacy, the investigator or designated representative is required to enter all information required into the electronic case report form after anonymisation. Automatic checks for data completeness, validity, and consistency were performed using the data capturing system of WJOG. The investigator or designated representative is obliged to clarify or respond to any queries generated. Each dataset is checked for errors or inconsistencies before creating a comprehensive dataset. Data access is limited to the authors and research assistants of the WJOG research team. | PMC10403909 |
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Ethical aspects and trial registration | Cancer | CANCER | The RETRIEVE study (WJOG15822G) was approved by the Certified Review Board of Shizuoka Cancer Center (CRB4180010) and prospectively registered in the Japan Registry of Clinical Trials (jRCTs041220120, 24 January 2023 | PMC10403909 |
Discussion | cancer, tumour, CRC | CANCER, TUMOUR, ADENOCARCINOMA, GASTRIC CANCER | Paclitaxel plus RAM is established as a standard treatment of second-line treatment for advanced GC according to the result of RAINBOW trial [The therapeutic development of FTD/TPI plus anti-angiogenic drugs is more advanced for CRC than for gastric cancer. Preclinical studies have reported that the combination of FTD/TPI and bevacizumab further suppressed tumour growth compared to FTD/TPI monotherapy in xenograft models of CRC cells [Recently, nivolumab combined with chemotherapy in the first-line setting recently showed significant superiority to chemotherapy alone in both OS and PFS in advanced GC patients according to the result of the CheckMate 649 trial [There are other candidates for the combination chemotherapy in the third-line chemotherapy for patients with advanced GC and EGJ adenocarcinoma. Mizukami et al. recently reported the clinical outcomes of a phase I trial of FTD/TPI plus irinotecan for third- or later- line treatment for GC patients [Recently, INTEGRATE IIa, a randomised phase III study of regorafenib versus placebo in refractory advanced GC or EGJ cancer showed that regorafenib significantly improved OS compared with placebo [ | PMC10403909 |
Acknowledgements | We would like to thank the data managers and other supporting staff at WJOG, Kaori Mori, Shinichiro Nakamura, and Koji Takeda. | PMC10403909 |
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Authors’ contributions | NB | NT and HH developed the concept of the study and initiated the project. KN performed the statistical analyses. KH, TM, TM, HK, KY, SH, NB, and KM contributed to the trial design, modifications, and data collection. NT drafted the paper. All the authors have read and approved the final manuscript. | PMC10403909 |
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Funding | This clinical trial was funded by Taiho Pharmaceutical Co. Ltd., Japan. The funding source had no role in the study design and has no role in data collection, data analysis, and interpretation or the decision to submit results for presentation or publication. | PMC10403909 |
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Availability of data and materials | RECRUITMENT | Patient recruitment began in January 2023 and is currently ongoing. We plan to publish these results in a future study. Authorship will be conducted according to the standards set by the International Committee of Medical Journal Editors ( | PMC10403909 |
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Declarations | PMC10403909 |
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Ethics approval and consent to participate | Cancer | CANCER | This study was approved by the Certified Review Board of Shizuoka Cancer Center (CRB4180010), and permission to conduct the study was obtained from the management of all participating facilities. Written informed consent is obtained from all participants. | PMC10403909 |
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