[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420432":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":37,"locations":43,"responsibleParty":220,"collaborators":222,"id":245,"slug":246,"hasResults":247,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":247,"sex":253,"minAge":254,"maxAge":23,"enrollmentInfo":255,"targetDuration":23,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":267,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous aerobic and resistance exercise (AE+RE)","EXPERIMENTAL","Two 60 min moderate-to-high intensity exercise sessions per week supervised by a physiotherapist.\n\nContinuous aerobic exercise: 15-20 min continuous aerobic exercise (e.g. walking) of moderate intensity (Borg 13-14 'somewhat hard').\n\nResistance exercise (25 min): 6 exercises targeting large muscle groups vertical row, squat, bench press, pull over, abdominal crunch, and lunge. 2 sets of 10 repetitions at 70-80% of 1 RM. To ensure adequate training load over time, tests are repeated every 3\u002F4 weeks aligned with the chemotherapy cycle.\n\nOne additional (third) session from home at moderate intensity for at least 30 min.\n\nA brochure with exercise guidelines is provided.",[13],"Behavioral: Continuous aerobic and resistance exercise intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Continuous aerobic and aerobic interval exercise (AE+AI)","Continuous aerobic exercise: 15-20 min continuous aerobic exercise (e.g. walking) of moderate intensity (Borg 13-14 'somewhat hard').\n\nAerobic interval (25 min): cycling with high intensity intervals alternated with recovery intervals. Intensity of the interval: between 85% and 95% of estimated maximum heart rate, adjusted to Borg 16-18 'hard - very hard'. In between the intervals, light intensity cycling will be performed for active recovery at 30% of Wmax estimated from Steep ramp test and adjusted to Borg \\\u003C 12.\n\nOne additional (third) session from home at moderate intensity for at least 30 min.\n\nA brochure with exercise guidelines is provided.",[18],"Behavioral: Continuous aerobic and aerobic interval exercise intervention",{"label":20,"type":21,"description":22,"interventionNames":23},"Usual care control group","NO_INTERVENTION","Patients in the usual care group receive care as usual. In addition, a brochure with exercise guidelines for cancer survivors is provided",null,[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Continuous aerobic and resistance exercise intervention","Continuous aerobic and resistance exercises intervention",[9],[31],"AE+RE",{"type":26,"name":33,"description":33,"armGroupLabels":34,"otherNames":35},"Continuous aerobic and aerobic interval exercise intervention",[15],[36],"AE+AI",[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Laurien M Buffart, PhD","CONTACT","+31243613674","laurien.buffart@radboudumc.nl",[44,62,75,88,101,116,125,141,154,167,180,195,205],{"facility":45,"status":46,"city":47,"state":23,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Jeroen Bosch Ziekenhuis","RECRUITING","'s-Hertogenbosch","5223 GZ","Netherlands","NL",{"type":52,"coordinates":53},"Point",[54,55],5.30417,51.69917,{"lat":55,"lon":54},[58,60],{"name":59,"role":40,"phone":23,"phoneExt":23,"email":23},"M. Wumkes, MD",{"name":59,"role":61,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"facility":63,"status":46,"city":64,"state":23,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Flevoziekenhuis","Almere Stad","1315 RA",{"type":52,"coordinates":67},[68,69],5.21413,52.37025,{"lat":69,"lon":68},[72,74],{"name":73,"role":40,"phone":23,"phoneExt":23,"email":23},"D. Sommeijer, MD",{"name":73,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":76,"status":46,"city":77,"state":23,"zip":78,"country":49,"countryCode":50,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Meander Medisch Centrum","Amersfoort","3813TZ",{"type":52,"coordinates":80},[81,82],5.3875,52.155,{"lat":82,"lon":81},[85,87],{"name":86,"role":40,"phone":23,"phoneExt":23,"email":23},"H.M. Otten, MD",{"name":86,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":89,"status":46,"city":90,"state":23,"zip":91,"country":49,"countryCode":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Ziekenhuis Amstelland","Amstelveen","1186AM",{"type":52,"coordinates":93},[94,95],4.86389,52.30083,{"lat":95,"lon":94},[98,100],{"name":99,"role":40,"phone":23,"phoneExt":23,"email":23},"A.A. v Zweeden, MD",{"name":99,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":102,"status":46,"city":103,"state":23,"zip":104,"country":49,"countryCode":50,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Amsterdam UMC","Amsterdam","1007MB",{"type":52,"coordinates":106},[107,108],4.88969,52.37403,{"lat":108,"lon":107},[111,113,114],{"name":112,"role":40,"phone":23,"phoneExt":23,"email":23},"T.E. Buffart, MD",{"name":112,"role":61,"phone":23,"phoneExt":23,"email":23},{"name":115,"role":61,"phone":23,"phoneExt":23,"email":23},"K.S. Versteeg, MD",{"facility":117,"status":46,"city":103,"state":23,"zip":23,"country":49,"countryCode":50,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Netherlands Cancer Institute",{"type":52,"coordinates":119},[107,108],{"lat":108,"lon":107},[122,124],{"name":123,"role":40,"phone":23,"phoneExt":23,"email":23},"K. Bolhuis, MD",{"name":123,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":126,"status":46,"city":127,"state":23,"zip":128,"country":49,"countryCode":50,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Rijnstate Ziekenhuis","Arnhem","6815 AD",{"type":52,"coordinates":130},[131,132],5.91111,51.98,{"lat":132,"lon":131},[135,137,138],{"name":136,"role":40,"phone":23,"phoneExt":23,"email":23},"R. Koornstra, MD",{"name":136,"role":61,"phone":23,"phoneExt":23,"email":23},{"name":139,"role":140,"phone":23,"phoneExt":23,"email":23},"I. Werter, MD","SUB_INVESTIGATOR",{"facility":142,"status":46,"city":143,"state":23,"zip":144,"country":49,"countryCode":50,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Ziekenhuis Amphia","Breda","4818CK",{"type":52,"coordinates":146},[147,148],4.77596,51.58656,{"lat":148,"lon":147},[151,153],{"name":152,"role":40,"phone":23,"phoneExt":23,"email":23},"M. Streppel, MD",{"name":152,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":155,"status":46,"city":156,"state":23,"zip":157,"country":49,"countryCode":50,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Catharina Ziekenhuis","Eindhoven","5623 EJ",{"type":52,"coordinates":159},[160,161],5.47778,51.44083,{"lat":161,"lon":160},[164,166],{"name":165,"role":40,"phone":23,"phoneExt":23,"email":23},"G.J. Creemers, MD",{"name":165,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":168,"status":46,"city":169,"state":23,"zip":170,"country":49,"countryCode":50,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Spaarne Gasthuis","Hoofddorp","2134TM",{"type":52,"coordinates":172},[173,174],4.68889,52.3025,{"lat":174,"lon":173},[177,179],{"name":178,"role":40,"phone":23,"phoneExt":23,"email":23},"A. Beeker, MD",{"name":178,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":181,"status":46,"city":182,"state":23,"zip":183,"country":49,"countryCode":50,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Radboudumc","Nijmegen","6525GA",{"type":52,"coordinates":185},[186,187],5.85278,51.8425,{"lat":187,"lon":186},[190,192,194],{"name":191,"role":40,"phone":23,"phoneExt":23,"email":23},"L. Buffart, Dr.",{"name":193,"role":61,"phone":23,"phoneExt":23,"email":23},"E. Gootjes, MD",{"name":191,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":196,"status":46,"city":182,"state":23,"zip":197,"country":49,"countryCode":50,"cosmosGeoPoint":198,"geoPoint":200,"contacts":201},"Canisius Wilhelmina Ziekenhuis","6532SZ",{"type":52,"coordinates":199},[186,187],{"lat":187,"lon":186},[202,204],{"name":203,"role":40,"phone":23,"phoneExt":23,"email":23},"J.J.B. Janssen, MD",{"name":203,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":206,"status":46,"city":207,"state":23,"zip":208,"country":49,"countryCode":50,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"UMCU","Utrecht","3508GA",{"type":52,"coordinates":210},[211,212],5.12222,52.09083,{"lat":212,"lon":211},[215,217,219],{"name":216,"role":40,"phone":23,"phoneExt":23,"email":23},"A. May, Prof.",{"name":218,"role":61,"phone":23,"phoneExt":23,"email":23},"J. Roodhart, Dr.",{"name":216,"role":61,"phone":23,"phoneExt":23,"email":23},{"type":221,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[223,225,227,229,230,231,233,235,236,238,239,241,243],{"name":224,"class":6},"UMC Utrecht",{"name":226,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"name":228,"class":6},"Rijnstate Hospital",{"name":45,"class":6},{"name":63,"class":6},{"name":232,"class":6},"Catharina Ziekenhuis Eindhoven",{"name":234,"class":6},"Meander Medical Center",{"name":89,"class":6},{"name":237,"class":6},"Amphia Hospital",{"name":168,"class":6},{"name":240,"class":6},"Canisius-Wilhelmina Hospital",{"name":242,"class":6},"Amsterdam UMC, location VUmc",{"name":244,"class":6},"The Netherlands Cancer Institute","100420432","aerobic-fitness-or-muscle-mass-training-to-improve-colorectal-cancer-outcome-100420432",false,"NCT04754672","Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome","Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome (AMICO). The Effects of Exercise on Chemotherapy Dose Modification and Progression Free Survival in Patients With Metastatic Colorectal Cancer","AMICO","Inclusion Criteria:\n\n* mCRC with indication for palliative chemotherapy\n* scheduled for treatment with first-line doublet or triplet chemotherapy, according to the national guideline\n* able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* life expectancy \\\u003C6 months\n* unable to perform basic activities of daily living such as walking or biking\n* presence of cognitive disorders or severe emotional instability (e.g., Schizophrenia, Alzheimer, alcohol addiction);\n* presence of other disabling co-morbidities that might hamper physical exercise (e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis);\n* insufficient mastery of the Dutch language;\n* presence of serious cardiovascular or cardiopulmonary conditions (e.g. unstable angina, arrhythmia or valve disease) such that exercise safety is at risk, as judged by the treating physician.\n* Already participating in structured vigorous aerobic and\u002For resistance exercise ≥ 2 times per week comparable to our intervention","ALL","18 Years",{"count":256,"type":257},228,"ESTIMATED","INTERVENTIONAL",[260],"NA","Evidence from randomized controlled trials shows that exercise during cancer treatment benefits physical fitness, fatigue and quality of life. Since the effect of exercise on clinical outcome is currently unknown, exercise is not included as integral part of standard cancer care. Moreover, evidence regarding the optimal exercise prescription in terms of type and dose is lacking.\n\nTo maintain quality of life in patients receiving palliative treatment with chemotherapy, toxicity-induced modifications in the prescribed chemotherapy dose are common. Such modifications - occurring in 40% of patients with metastatic colorectal cancer - may reduce benefit of treatment. The investigators hypothesize that exercise prevents chemotherapy dose modifications by reducing toxicity and enhancing psychological strength. Additionally, based on studies in rodents and preliminary data in patients with cancer, the researchers hypothesize that exercise has beneficial effects on the functionality of the natural killer cells, which play an important role in the innate immune defense against cancer. Both, fewer dose modifications and improved immune function may improve progression-free survival.\n\nThis study is a three-armed trial comparing resistance exercise, aerobic interval exercise and usual care in patients with metastatic colorectal cancer to select the optimal exercise prescription for preventing chemotherapy dose modifications. The trial will use a Bayesian adaptive multi-arm multi-stage design with several interim analyses after which an ineffective study arm can be dropped early. This novel design makes the trial more efficient and reduces patients' exposure to suboptimal study arms.\n\nEvidence regarding the exercise effects on i) clinical outcome, ii) the optimal exercise prescription, and iii) the underlying mechanisms, elucidates the potential of exercise to boost benefit from chemotherapy treatment. This evidence provides leads to improve progression-free survival and quality of life of patients suffering from one of the leading causes of cancer death worldwide.",[263,264,265,266],"Colorectal Cancer","Chemotherapeutic Toxicity","Survivorship","Lifestyle",[268,269,270,271,272,273,274],"Exercise","Muscle strength","Cardiorespiratory fitness","Colorectal cancer","Chemotherapy dose modification","Progression free survival","Bayesian adaptive trial","2023-11-16",{"date":277,"type":278},"2023-11-18","ACTUAL",{"date":280,"type":278},"2021-03-02",{"date":282,"type":257},"2026-12",{"name":5,"class":6},13]