[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451637":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":76,"collaborators":34,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":34,"enrollmentInfo":88,"targetDuration":34,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":34,"overallStatus":69,"whyStopped":34,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Radio-induced oral mucositis \u002F Medical Device","EXPERIMENTAL","Patient with radio-induced oral mucositis at least grade 2 treated with experimental medical device",[13],"Device: Topical application of Orosol®",{"label":15,"type":16,"description":17,"interventionNames":18},"Radio-induced oral mucositis \u002F Placebo comparator","PLACEBO_COMPARATOR","Patient with radio-induced oral mucositis at least grade 2 treated with placebo",[19],"Device: Topical application of Placebo comparator",{"label":21,"type":10,"description":22,"interventionNames":23},"Chemo-induced oral mucositis \u002F Medical Device","Patient with chemo-induced oral mucositis at least grade 2 treated with experimental medical device",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Chemo-induced oral mucositis \u002F placebo comparator","Patient with chemo-induced oral mucositis at least grade 2 treated with placebo",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Topical application of Orosol®","Orosol® is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Orosol® every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.",[21,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Topical application of Placebo comparator","Placebo comparator is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Placebo comparator every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.",[25,15],[40],{"name":41,"affiliation":5,"role":42},"Laurent Devoize","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Lise Laclautre","CONTACT","334.73.754.963","promo_interne_drci@chu-clermontferrand.fr",[50,67],{"facility":51,"status":52,"city":53,"state":34,"zip":34,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Centre Jean-Perrin","NOT_YET_RECRUITING","Clermont-Ferrand","France","FR",{"type":57,"coordinates":58},"Point",[59,60],3.08682,45.77969,{"lat":60,"lon":59},[63,65],{"name":64,"role":46,"phone":34,"phoneExt":34,"email":34},"lise Laclautre",{"name":66,"role":42,"phone":34,"phoneExt":34,"email":34},"Michel Lapeyre",{"facility":68,"status":69,"city":53,"state":34,"zip":34,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"CHU clermont-ferrand","RECRUITING",{"type":57,"coordinates":71},[59,60],{"lat":60,"lon":59},[74,75],{"name":45,"role":46,"phone":34,"phoneExt":34,"email":34},{"name":41,"role":42,"phone":34,"phoneExt":34,"email":34},{"type":77,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100451637","efficacy-of-orosol-in-the-treatment-of-chemo--and-radiation-induced-mucositis-100451637",false,"NCT05161091","Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.","Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.","OROSOL","Inclusion Criteria:\n\n* Adult patient, male or female, either\n\n  * treated with chemotherapy for hematological cancer (leukemia, lymphoma) and suffering from grade 2 to 4 mucositis (according to WHO \u002F NCI-CTCAE), or\n  * treated with radiotherapy or radio-chemotherapy (cisplatin or cetuximab) for head and neck cancer and suffering from grade 2 to 4 mucositis (according to WHO \u002F NCI-CTCAE),\n* Agreeing not to take any treatment for mucositis other than the treatment proposed in this study, apart from the classic symptomatic treatment for mucositis recommended by WHO.\n* Able to give informed consent to participate in research.\n* Beneficiary of a Social Security scheme.\n\nExclusion Criteria:\n\n* A woman who is pregnant, breastfeeding, or may be.\n* Major subject under guardianship, curators, deprived of liberty, or under the safeguard of justice.\n* Medical and \u002F or surgical history deemed by the investigator to be incompatible with the study because it would invalidate any reliable assessment.\n* General state of health considered pejorative (Karnofsky index \\\u003C60).\n* Type 1 or type 2 diabetic subject (presence of honey in Orosol®).\n* Subject on an anticoagulant (AVK or AOD) (interaction of the cranberry contained in Orosol® with anticoagulants (in particular warfarin) with instability of the International Normalized Ratio; the AODs can potentially present the same type of interaction).\n* History of administration of the treatment (or equivalent) in the study.\n* Anticipated difficulties in reading \u002F understanding the protocol and its questionnaires.\n* Subjects in the exclusion period from another clinical trial\n* Refusal of participation.","ALL","18 Years",{"count":89,"type":90},54,"ESTIMATED","INTERVENTIONAL",[93],"NA","Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants.\n\nIt is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and \u002F or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing.\n\nDepending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease.\n\nAlthough, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.",[96],"Oral Mucositis","2024-08-09",{"date":99,"type":100},"2024-08-12","ACTUAL",{"date":102,"type":100},"2022-11-22",{"date":104,"type":90},"2026-12",{"name":5,"class":6},2]