[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mucosa Innovations, S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100488116","effect-of-a-novel-topical-composition-on-the-incidence-of-severe-oral-mucositis-in-head--neck-cancer-radiated-patients-and-quality-of-life-assessed-by-proms-100488116",false,"NCT05635929","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.","STOPOMP","Inclusion Criteria:\n\nAcute Phase\n\n* Patients diagnosed with Head \\& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nChronic Phase\n\n* Patients who have completed radiotherapy treatment at least 6 months before study enrollement.\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nExclusion Criteria:\n\nAcute Phase\n\n* Patients who are unable to properly use the products.\n* Patients who do not consent to participate in the study.\n* Patients who were being treated for another type of cancer.\n\nChronic Phase\n\n* Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.\n* Patients who do not consent to participate in the study.","ALL","18 Years",{"count":20,"type":21},63,"ESTIMATED","INTERVENTIONAL",[24],"NA","The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \\& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \\& Neck cancer radiated patients.",[27,28,29,30,31,32,33,34,35],"Oral Mucositis","Quality of Life","Mucositis","Pain","Speech","Saliva","Radiation Toxicity","Chemotherapeutic Toxicity","Head and Neck Cancer",[27,37,38,30,39,40,41,42,43,35,44],"Cancer Therapy Toxic Effect","Cancer Support","Ulcers","Treatment Interruptions","Oral Mucosa","Radiotherapy","Chemotherapy","Severe Oral Mucositis","RECRUITING","2026-04-10",{"date":48,"type":49},"2026-04-15","ACTUAL",{"date":51,"type":49},"2022-10-11",{"date":53,"type":21},"2027-03",{"name":55,"class":56},"Mucosa Innovations, S.L.","INDUSTRY",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":83,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":57},"100590048","changes-in-the-impact-of-genitourinary-syndrome-of-menopause-with-a-novel-nonhormonal-vulvovaginal-gel-assessed-by-proms-100590048","NCT06962345","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.","STOPGSMP","Inclusion Criteria:\n\n* Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).\n* Patient must be postmenopausal with at least 1 year without a menstrual period.\n* Patient must consider that her quality of life is affected by GSM symptoms\n* Patient not followed due to any gynecological disease.\n* All participants must be able to understand and to fill in the self-reported questionnaires.\n\nExclusion Criteria:\n\n* Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.\n* Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.\n* Patients with history of vulvar, vaginal and\u002For cervical malignancy.\n* Patients having received radiotherapy treatment in the pelvic and\u002For genital region.\n* Patients with any type of disease that causes alteration of collagenogenesis.\n* Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.\n* Patients having received laser and\u002For radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.\n* Patients with active urinary and\u002For genital tract infection.\n* Patients with history of malignant neoplasm of the urinary system.\n* Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).\n* Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.\n* Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.\n* Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and\u002For following the established procedures.","FEMALE","40 Years","70 Years",{"count":70,"type":21},80,[24],"The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.",[74,75,76,28,77,78,79,80,81,82],"Vulvar Atrophy","Vulvovaginal Signs and Symptoms","Genitourinary Syndrome of Menopause","Menopause Related Conditions","Dyspareunia","Urinary Incontinence, Urgency-frequency","Sexual Function","Women´s Health","Vaginal Dryness",[76,75,84,28,85,81],"Patient Reported Outcome Measures","Day-to-Day Impact of Vaginal Ageing","2026-03-25",{"date":88,"type":49},"2026-03-30",{"date":90,"type":49},"2024-01-08",{"date":92,"type":21},"2026-12",{"name":55,"class":56},""]