[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437653":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":64,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":20,"enrollmentInfo":78,"targetDuration":20,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Jessa Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","The experimental group receives 9 sessions of photobiomodulation therapy (3x\u002Fweek for 3 weeks).",[13],"Device: Photobiomodulation therapy (PBMT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Photobiomodulation therapy (PBMT)","Patients will receive PBM on the sole of their feet and palms of their hands",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jeroen Mebis, MD, PhD","Head of Medical Oncology Department","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+32 11 33 72 21","Jeroen.mebis@jessazh.be",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Jolien Robijns, PhD","+32 11 33 72 29","jolien.robijns@uhasselt.be",[36,54],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hasselt University","NOT_YET_RECRUITING","Hasselt","Limburg","3500","Belgium","BE",{"type":45,"coordinates":46},"Point",[47,48],5.33781,50.93106,{"lat":48,"lon":47},[51,53],{"name":23,"role":28,"phone":20,"phoneExt":20,"email":52},"Jeroen.mebis@uhasselt.be",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"facility":55,"status":56,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Jessa Ziekenhuis VZW","RECRUITING",{"type":45,"coordinates":58},[47,48],{"lat":48,"lon":47},[61,62],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":63,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":65,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[67],{"name":37,"class":6},"100437653","photobiomodulation-therapy-in-the-management-of-hand-foot-syndrome-and-hand-foot-skin-reaction-100437653",false,"NCT04979078","Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction","Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial","DermLight","Inclusion Criteria:\n\n* Diagnosed with cancer of different aetiologies\n* Undergoing chemotherapy or targeted therapy (TKIs)\n* Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5)\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot)\n* Known allergy to polyurethane\n* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator","ALL","18 Years",{"count":79,"type":80},40,"ESTIMATED","INTERVENTIONAL",[83],"NA","Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and\u002For soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and\u002For feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).\n\nPhotobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and\u002For near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.",[86,87],"Hand-foot Syndrome","Hand-foot Skin Reaction",[89,90,91,92,93,94,95,96,97],"Dermatology","Oncology","Photobiomodulation","Skin toxicity","Hand-foot syndrome","Hand-foot skin reaction","Hand-foot skin toxicity","Supportive cancer care","Light therapy","2023-06-15",{"date":100,"type":101},"2023-06-18","ACTUAL",{"date":103,"type":101},"2022-01-12",{"date":105,"type":80},"2029-08",{"name":5,"class":6},2]