[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653254":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":27,"studyPopulation":27,"armGroups":52,"interventions":59,"overallOfficials":64,"centralContacts":69,"locations":78,"responsibleParty":86,"collaborators":90,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":27,"enrollmentInfo":111,"targetDuration":27,"studyType":114,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":125,"whyStopped":27,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":28},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"Adverse events","Adverse events will be extracted from medical records (including adjustment to treatment plans, adjunct medications or procedures) and categorized according to the Common Terminology Criteria for Adverse Events, version 5.0.\n\nIn addition, before and after each infusion, the intra-infusion exercise group will be asked whether they have experienced any harmful or undesirable outcomes, with additional prompts to better understand the severity and impact of such events.\n\nSpecific adverse events:\n\nCardiac function and skeletal muscle damage: Routine echocardiography data will be extracted from medical records in both groups. Further, serum troponin I levels (a biomarker used in the early detection of cardiotoxicity) and serum creatine kinase (a biomarker routinely used to assess skeletal muscle damage) will be taken in conjunction with routine blood work in the exercise group.","From the commencement of chemotherapy and up to six months post-chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants.",{"measure":14,"description":15,"timeFrame":16},"Feasibility: recruitment rate","Feasibility of intra-infusion exercise will be assessed by analyzing the number accepting participation in intra-infusion exercise vs. number eligible","From initiation of participant recruitment in the department until recruitment of last participant. Anticipated within one year.",{"measure":18,"description":19,"timeFrame":20},"Feasibility: retention rate","Feasibility of intra-infusion exercise will be asessed by analyzing the number of participants who remained in the study vs. number enrolled.","From the first intra-infusion exercise session to the end of chemotherapy treatment (or up to 6 months if treatment continues beyond 6 months).",{"measure":22,"description":23,"timeFrame":20},"Feasibility: attendance rate","Feasibility of intra-infusion exercise be assessed by analyzing the number of intra-infusion exercise sessions completed vs. number possible.",{"measure":25,"description":26,"timeFrame":20},"Feasibility: Adherence exercise intensity","Feasibility of intra-infusion exercise will be assessed by analyzing the number of exercise sessions meeting exercise intensity target vs. number of exercise sessions possible.",null,[29,33,37,41],{"measure":30,"description":31,"timeFrame":32},"Tumor perfusion","In the intra-infusion exercise group, tumor perfusion under resting and exercise conditions will be assessed prior to initiating chemotherapy using single-photon emission computed tomography and computed tomography (SPECT\u002FCT) with radioactive tracer (99mTc-Sestamibi (MIBI)). During exercise conditions, participants will be injected intravenously with MIBI at the end of a 15-minute exercise session (moderate target intensity). Because MIBI does not wash out or redistribute significantly, the images captured using SPECT\u002FCT within 30-60 minutes reflect the perfusion at the exact moment of injection, providing a snapshot of blood flow in the tumor.","Within a one-week time frame, prior to chemotherapy initiation.",{"measure":34,"description":35,"timeFrame":36},"Patient-reported quality-of-life","This is an exploratory outcome to assess which patient reported outcomes are relevant to explore in future work. Quality-of-life parameters using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) have been collected as part of routine care (in conjunction with scan result oncology consults) since 2021. As such quality-of-life data is available for both groups through medical records. This well-validated, questionnaire comprises five functional scales, nine symptom scales or items and a global health status\u002Fquality of life scale. Values range from 0 to 100. Whether a higher score means a better or worse outcome depends on the specific scale type: higher scores indicate a better outcome for functional and global health scales, but a worse outcome for symptom scales.","From enrollment and up to six months after chemotherapy",{"measure":38,"description":39,"timeFrame":40},"Patient-reported emotional well-being","This is an exploratory outcome to assess which patient-reported outcomes are relevant to explore in future work. In addition to patient-reported quality-of life (collected as usual care in conjunction with scan result oncology consults since 2021) the intra-infusion exercise group will also be asked to fill out the Hospital Anxiety and Depression Scale (HADS). This 14-item questionnaire is widely used in cancer and screens for anxiety and depressive states with values ranging from 0 to 21 for each individual subscale (anxiety and depression), or 42 for the combined total score. Higher scores mean a worse outcome, indicating higher levels of anxiety, depression, or overall psychological distress.","From enrollment and up to six months post-treatment.",{"measure":42,"description":43,"timeFrame":44},"Experience and acceptability of intra-infusion exercise","A semi-structured interview will be carried out to explore patient-centered experience and acceptability of intra-infusion exercise.","After completion of chemotherapy. As sarcomas are a heterogeneous group of cancers, chemotherapy regimens, including duration, will vary between participants.",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":27,"timePerspective":27,"maskingInfo":50},"NA","SINGLE_GROUP","The intervention group will be compared to a historical control.","SUPPORTIVE_CARE",{"masking":51,"maskingDescription":27,"whoMasked":27},"NONE",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Intra-infusion exercise","EXPERIMENTAL","The first cycle of chemotherapy will be delivered as per usual care. During all subsequent cycles, participants will partake in intra-infusion aerobic exercise (e.g. pedal ergometer, stationary bike). Exercise will follow a 15-minute exercise \u002F 15-minute rest interval, totalling 30 minutes of exercise per hour of infusion. Participants will be monitored using the Borg rate of perceived exertion (RPE) scale (range 6-20) and heart rate monitors. Target intensity will be low (Borg RPE 10-12) for the first five minutes, increasing to moderate intensity (Borg RPE 13-15) for the last ten minutes. As a precautionary measure, only low-intensity exercise will be performed when receiving cytostatic agents known to carry an increased risk of cardiotoxicity (e.g. anthracyclines). Exercise will be supervised by a physical therapist with experience in exercise oncology, alongside oncology nurses as per usual care.",[58],"Other: Exercise",[60],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":27},"Exercise","See description of study arm",[54],[65],{"name":66,"affiliation":67,"role":68},"Kira Bloomquist, Physical therapist, MHS, PhD","Center for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet","PRINCIPAL_INVESTIGATOR",[70,74],{"name":66,"role":71,"phone":72,"phoneExt":27,"email":73},"CONTACT","+45 35457362","kira.bloomquist@regionh.dk",{"name":75,"role":71,"phone":76,"phoneExt":27,"email":77},"Anders Vinther, Physical therapist, PhD","+45 26808710","Anders.Vinther@regionh.dk",[79],{"facility":80,"status":27,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":27,"geoPoint":27,"contacts":27},"Department of Oncology, Herlev Hospital","Herlev","Region Sjælland","2730","Denmark","DK",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Kira Bloomquist","Researcher",[91,93,96,98,99],{"name":92,"class":6},"Danish Cancer Society",{"name":94,"class":95},"Center for Physical Activity Research (CFAS)","UNKNOWN",{"name":97,"class":95},"Department of Nuclear Medicine, Herlev Hospital",{"name":80,"class":95},{"name":100,"class":95},"Copenhagen Research Center for Cancer Rehabilitation (CORE-Cancer), Herlev Hospital","100653254","sarcoma-and-intra-infusion-exercise-for-better-outcomes-100653254",false,"NCT07785882","Sarcoma and Intra-infusion Exercise for Better Outcomes","Sarcoma and Intra-infusion Exercise for Better Outcomes: The SEB-trial","SEB","Inclusion Criteria:\n\n* Initiating at least two series of chemotherapy for non-resected sarcoma at Clinic 6, Herlev Hospital, Denmark\n* Eastern Cooperative Oncology Group performance status of 0-2\n* No mental or physical disabilities precluding exercise\n* Approval by the treating oncologist\n* Able to read Danish\n* Willing to sign informed consent\n\nExclusion Criteria:\n\n* Home-based chemotherapy\n* Infusions lasting under one hour\n* Elevated risk for developing cardiac issues (left ventricular ejection fraction ≤50%) based on routine echocardiography","ALL","18 Years",{"count":112,"type":113},16,"ESTIMATED","INTERVENTIONAL",[46],"The main goal of this clinical trial is to determine: 1) the safety and 2) feasibility of moderate-intensity, intra-infusion aerobic exercise in people receiving chemotherapy for non-resected sarcoma and 3) assess whether intra-infusion exercise acutely increases tumor perfusion.\n\nThe trial aims to answer the following research questions:\n\n* Is intra-infusion aerobic exercise safe in people receiving chemotherapy for sarcoma?\n* Is intra-infusion aerobic exercise feasible in people receiving chemotherapy for sarcoma?\n* Does aerobic exercise induce acute increases in tumor perfusion?\n* In future work, which patient reported outcomes are relevant to explore in people receiving chemotherapy for sarcoma?\n\nAdverse event data and patient-reported quality-of-life outcomes will be compared to those of a historical control comprising patients who received chemotherapy for sarcoma within three years prior to study initiation.\n\nParticipants will:\n\n* Participate in light- to moderate-intensity aerobic exercise during chemotherapy infusion (intra-infusion exercise) for the duration of their treatment protocol.\n* Exercise will follow a 15-minute exercise \u002F 15-minute rest interval, totaling 30 minutes of exercise per hour of infusion.\n* Prior to initiating chemotherapy, undergo a single 15-minute exercise session. During peak exercise, a radioactive tracer will be injected intravenously followed by a single-photon emission computed tomography and computed tomography (SPECT \u002FCT) scan to obtain images of tumor perfusion. A resting SPECT\u002FCT scan will also be performed.",[118],"Sarcoma",[120,121,122,123,124],"exercise","chemotherapy","feasibility","adverse events","tumor perfusion","NOT_YET_RECRUITING","2026-08-21",{"date":128,"type":129},"2026-08-25","ACTUAL",{"date":131,"type":113},"2027-01-01",{"date":133,"type":113},"2028-10-31",{"name":88,"class":6},1]