[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526705":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":279,"collaborators":282,"id":284,"slug":285,"hasResults":286,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":286,"sex":291,"minAge":292,"maxAge":12,"enrollmentInfo":293,"targetDuration":12,"studyType":296,"phases":297,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":320},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","NO_INTERVENTION","Patients randomized to the control group will receive standard medical care, including nutritional care as provided by the center in usual care. Additionally, they receive an activity tracker (like the intervention group) but without specific instructions. We will provide the control patients with written advice on physical activity and diet according to the current guidelines (in short: to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150 min\u002Fweek).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Combined exercise and nutritional intervention.","EXPERIMENTAL","Intervention: exercise and nutrition program group",[18,19],"Other: Exercise intervention","Other: Nutrition intervention",[21,25],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"Exercise intervention","During 12 weeks, patients will visit twice a week a trained oncology physiotherapist for one hour per session. This training includes supervised aerobic and resistance exercises to increase aerobic condition and muscle resistance, based on their own fitness level as assessed at baseline. Additionally, physiotherapists will educate participants on how to increase their daily activity. To this end, all participants will receive an activity tracker to monitor their daily activities.",[14],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"Nutrition intervention","Once every two weeks patients in the intervention group will receive a nutritional assessment and intervention by a trained dietician for optimization of their nutritional intake to improve their nutritional status, following the ESPEN guideline on nutrition in cancer patients and the national guidelines of the National Nutritionists Oncology Working Group (NNOWG; in Dutch: Landelijke Werkgroep Diëtisten Oncologie, LWDO). Moreover, an amount of 15-25 grams of protein within 1-2 hours after exercise will be advised, to prevent muscle protein breakdown and enhance muscle protein synthesis.",[14],[30],{"name":31,"affiliation":32,"role":33},"Hanneke van Laarhoven","Amsterdam AMC","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":12,"email":39},"Aniek Bonhof, Msc","CONTACT","+31627437310","A.Bonhof-3@umcutrecht.nl",[41,59,72,81,92,104,115,126,137,148,159,170,181,192,200,211,222,233,241,252,263,268],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Amsterdam UMC","RECRUITING","Amsterdam","North Holland","1081HV","Netherlands","NL",{"type":50,"coordinates":51},"Point",[52,53],4.88969,52.37403,{"lat":53,"lon":52},[56],{"name":31,"role":37,"phone":57,"phoneExt":12,"email":58},"020 444 43 21","h.vanlaarhoven@amsterdamumc.nl",{"facility":60,"status":43,"city":61,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"UMC Utrecht","Utrecht","3508GA",{"type":50,"coordinates":64},[65,66],5.12222,52.09083,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":12,"phoneExt":12,"email":71},"Anne May","MaA.M.May@umcutrecht.nl",{"facility":73,"status":74,"city":75,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":12},"Jeroen Bosch Hospital","ACTIVE_NOT_RECRUITING","'s-Hertogenbosch",{"type":50,"coordinates":77},[78,79],5.30417,51.69917,{"lat":79,"lon":78},{"facility":82,"status":43,"city":83,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Flevoziekenhuis","Almere Stad",{"type":50,"coordinates":85},[86,87],5.21413,52.37025,{"lat":87,"lon":86},[90],{"name":91,"role":37,"phone":12,"phoneExt":12,"email":12},"Dirkje Sommeijer, MD",{"facility":93,"status":94,"city":95,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Meander Medical Center","NOT_YET_RECRUITING","Amersfoort",{"type":50,"coordinates":97},[98,99],5.3875,52.155,{"lat":99,"lon":98},[102],{"name":103,"role":37,"phone":12,"phoneExt":12,"email":12},"Ruben Goedegebuure, MD",{"facility":105,"status":43,"city":106,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Reinier de Graaf","Delft",{"type":50,"coordinates":108},[109,110],4.35556,52.00667,{"lat":110,"lon":109},[113],{"name":114,"role":37,"phone":12,"phoneExt":12,"email":12},"AJ Verschoor",{"facility":116,"status":43,"city":117,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Catharina Ziekenhuis","Eindhoven",{"type":50,"coordinates":119},[120,121],5.47778,51.44083,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":12,"phoneExt":12,"email":12},"IEG van Hellemond",{"facility":127,"status":43,"city":128,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Beatrix Hospital","Gorinchem",{"type":50,"coordinates":130},[131,132],4.97243,51.83652,{"lat":132,"lon":131},[135],{"name":136,"role":37,"phone":12,"phoneExt":12,"email":12},"Marjan Davidis-van Schoonhoven, MD",{"facility":138,"status":43,"city":139,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Spaarne Gasthuis","Hoofddorp",{"type":50,"coordinates":141},[142,143],4.68889,52.3025,{"lat":143,"lon":142},[146],{"name":147,"role":37,"phone":12,"phoneExt":12,"email":12},"A Beeker, Dr",{"facility":149,"status":43,"city":150,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Frisius Medical Center","Leeuwarden",{"type":50,"coordinates":152},[153,154],5.80973,53.20271,{"lat":154,"lon":153},[157],{"name":158,"role":37,"phone":12,"phoneExt":12,"email":12},"J Douma, Dr",{"facility":160,"status":43,"city":161,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Leiden Universitair Medisch Centrum","Leiden",{"type":50,"coordinates":163},[164,165],4.49306,52.15833,{"lat":165,"lon":164},[168],{"name":169,"role":37,"phone":12,"phoneExt":12,"email":12},"M Slingerland, Dr",{"facility":171,"status":94,"city":172,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Sint Antonius Hospital","Nieuwegein",{"type":50,"coordinates":174},[175,176],5.08056,52.02917,{"lat":176,"lon":175},[179],{"name":180,"role":37,"phone":12,"phoneExt":12,"email":12},"Karin Herbschleb, MD",{"facility":182,"status":43,"city":183,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Canisius Wilhelmina Ziekenhuis","Nijmegen",{"type":50,"coordinates":185},[186,187],5.85278,51.8425,{"lat":187,"lon":186},[190],{"name":191,"role":37,"phone":12,"phoneExt":12,"email":12},"Johan Janssen, Dr",{"facility":193,"status":43,"city":183,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"RadboudUMC",{"type":50,"coordinates":195},[186,187],{"lat":187,"lon":186},[198],{"name":199,"role":37,"phone":12,"phoneExt":12,"email":12},"Harm Westendorp, MD",{"facility":201,"status":43,"city":202,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Laurentius Ziekenhuis","Roermond",{"type":50,"coordinates":204},[205,206],5.9875,51.19417,{"lat":206,"lon":205},[209],{"name":210,"role":37,"phone":12,"phoneExt":12,"email":12},"MHW van de Poel, Dr",{"facility":212,"status":43,"city":213,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Bravis Ziekenhuis","Roosendaal",{"type":50,"coordinates":215},[216,217],4.46528,51.53083,{"lat":217,"lon":216},[220],{"name":221,"role":37,"phone":12,"phoneExt":12,"email":12},"S Boudewijns, Dr",{"facility":223,"status":43,"city":224,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Erasmus Medical Center","Rotterdam",{"type":50,"coordinates":226},[227,228],4.47917,51.9225,{"lat":228,"lon":227},[231],{"name":232,"role":37,"phone":12,"phoneExt":12,"email":12},"Bianca Mostert, MD",{"facility":234,"status":43,"city":224,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":235,"geoPoint":237,"contacts":238},"Ikazia Ziekenhuis",{"type":50,"coordinates":236},[227,228],{"lat":228,"lon":227},[239],{"name":240,"role":37,"phone":12,"phoneExt":12,"email":12},"J.C. Drooger, Dr",{"facility":242,"status":43,"city":243,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"HagaZiekenhuis","The Hague",{"type":50,"coordinates":245},[246,247],4.29861,52.07667,{"lat":247,"lon":246},[250],{"name":251,"role":37,"phone":12,"phoneExt":12,"email":12},"D Houtsma, Dr",{"facility":253,"status":43,"city":254,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Elisabeth Tweesteden Hospital","Tilburg",{"type":50,"coordinates":256},[257,258],5.0913,51.55551,{"lat":258,"lon":257},[261],{"name":262,"role":37,"phone":12,"phoneExt":12,"email":12},"Laurens Beerepoot, MD",{"facility":264,"status":94,"city":61,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":265,"geoPoint":267,"contacts":12},"Diakonessenhuis",{"type":50,"coordinates":266},[65,66],{"lat":66,"lon":65},{"facility":269,"status":43,"city":270,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Zaans Medical Center","Zaandam",{"type":50,"coordinates":272},[273,274],4.82643,52.43854,{"lat":274,"lon":273},[277],{"name":278,"role":37,"phone":12,"phoneExt":12,"email":12},"Sandra Bakker, MD",{"type":33,"investigatorFullName":280,"investigatorTitle":281,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Hanneke W. M. van Laarhoven","Head of Medical Oncology of Amsterdam AMC, Principal Investigator, Prof. dr. H.W.M. van Laarhoven",[283],{"name":60,"class":6},"100526705","the-effect-of-exercise-and-diet-on-quality-of-life-in-patients-with-incurable-cancer-of-esophagus-and-stomach-radices-100526705",false,"NCT06138223","The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)","RADICES","Inclusion Criteria:\n\n* Incurable adenocarcinoma of the esophagus or stomach\n* Recurrence after treatment with curative intent or irresectable\u002Fmetastatic disease at primary diagnosis. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with anticancer therapy are eligible for inclusion too)\\*\n* Able and willing to perform the exercise and nutritional program and wear the activity tracker.\n* Able and willing to fill out the POCOP\u002FRADICES questionnaires.\n* Life expectancy \\> 12 weeks.\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Unstable bone metastases inducing skeletal fragility as determined by the treating clinician.\n* Untreated symptomatic known brain metastasis.\n* Serious active infection.\n* Too physically active (i.e. \\>210 minutes\u002Fweek of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program.\n* Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria.\n* Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise.\n* Uncontrolled severe pain.\n* Any other contraindications for exercise as determined by the treating physician.\n* Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician.\n* Pregnancy.\n\n  * Note:\n\nAfter one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence\u002Fprogression of GAC after curative treatment or irresectable\u002Fmetastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. This was done to increase generalizability and offer the intervention earlier in the palliative phase to enhance its benefits. We acknowledge this results in a more heterogeneous group, but we believe also a more representative group.\n\nThe inclusion criterium before broadening was:\n\nProgressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric\u002Fesophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too.","ALL","18 Years",{"count":294,"type":295},196,"ESTIMATED","INTERVENTIONAL",[298],"NA","The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed.\n\nHowever, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment.\n\nA total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.",[301,302],"GastroEsophageal Cancer","Incurable Disease",[304,305,306,307,308,309,310],"gastroesophageal cancer","GAC","Palliative","exercise intervention","nutritional intervention","Quality of life","QOL","2026-05-03",{"date":313,"type":314},"2026-05-07","ACTUAL",{"date":316,"type":314},"2024-01-01",{"date":318,"type":295},"2028-09-30",{"name":5,"class":6},22]