[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655125":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":33,"studyPopulation":30,"armGroups":34,"interventions":47,"overallOfficials":57,"centralContacts":62,"locations":70,"responsibleParty":110,"collaborators":30,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":30,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":30,"enrollmentInfo":121,"targetDuration":30,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":138,"whyStopped":30,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Oral Mucositis","Number of participants that develop oral mucositis.","Day 28",[14,17],{"measure":15,"description":16,"timeFrame":12},"Participants with Worsening Grade of Mucositis","Number of participants with worsening grade of mucositis.",{"measure":18,"description":19,"timeFrame":12},"Participants with Improving Grade of Mucositis","Number of participants with improving grade of mucositis.",[21],{"measure":22,"description":23,"timeFrame":24},"Oral Mucositis Weekly Questionnaire Score","The Oral Mucositis Weekly Questionnaire is a patient-reported outcome instrument developed to measure oral mucositis impact on patients' daily life. The questionnaire includes 12 items that are individually assessed including: Global health and Quality of life with 2 items rated on 1-7 scale (higher score better); Mouth and throat soreness when present is measured with 7 items on 0-4 scale and 1 overall measure on 0-10 scale; mouth pain and throat pain are also each measured using 0-10 scale (lower scores better)","Baseline and every 7 days for 28 days",{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":30,"timePerspective":30,"maskingInfo":31},"NON_RANDOMIZED","SINGLE_GROUP","This study will apply a quasiexperimental cohort-controlled design. Phase 1 will enroll usual care group and Phase 2 will enroll intervention group.","SUPPORTIVE_CARE",null,{"masking":32,"maskingDescription":30,"whoMasked":30},"NONE","Oral mucositis (OM) is a common and debilitating complication of chemotherapy and radiotherapy among adults with acute leukemia, leading to pain, infection risk, treatment delays, and reduced quality of life. This multi-site, cohort controlled quasi-experimental study will evaluate the effectiveness of a nurse-led aloe vera mouthwash intervention compared with usual oral care in preventing and reducing the incidence and severity of OM among hospitalized oncology patients. Primary outcomes include OM incidence and severity measured by Common Terminology Criteria for Adverse Events (CTCAE), with secondary outcomes of pain, quality of life, and overall health assessed weekly using the Oral Mucositis Weekly Questionnaire (OMWQ).",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Phase 1 Usual Care","ACTIVE_COMPARATOR","Participants in the usual care phase will receive standard of care",[40],"Other: Standard of Care",{"label":42,"type":43,"description":44,"interventionNames":45},"Phase 2 Intervention","EXPERIMENTAL","Participants in the intervention phase will receive aloe vera",[46],"Dietary Supplement: Aloe Vera Mouthwash",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":30},"DIETARY_SUPPLEMENT","Aloe Vera Mouthwash","In addition to standard of care, phase 2 participants will receive the aloe vera mouthwash available for order through supply chain services. Health system pharmacy has approved this as a nonmedication and safe for administration with this patient population and other medications. Each participant will have their own bottle and be instructed to swish and spit 15ml (0.5 ounces) of mouthwash following usual oral care prior to meals and at bedtime (four times per day). Nursing staff assess the participants' oral cavity at least twice a day for mucosal integrity, pain, bleeding, or ulceration. While participants are inpatient, the routine oral assessments and administration of the aloe vera will be tracked via documentation in the electronic health record. If participants are discharged prior to 28 days, oral assessments and aloe vera use will be tracked via self-report by participants on the weekly questionnaire.",[42],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":30},"Standard of Care","Toothbrushing with a soft or ultra-soft toothbrush and fluoride toothpaste a minimum of twice a day, oral rinsing with water or 0.9% sodium chloride four times daily, and denture care as applicable.",[36],[58],{"name":59,"affiliation":60,"role":61},"Tara Albrecht, PhD, ACNP-BC, ACHPN, RN","Advocate Health","PRINCIPAL_INVESTIGATOR",[63,67],{"name":59,"role":64,"phone":65,"phoneExt":30,"email":66},"CONTACT","336.716.9619","tara.albrecht@aah.org",{"name":68,"role":64,"phone":65,"phoneExt":30,"email":69},"Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt","Jeanne.hlebichuk@aah.org",[71,87,100],{"facility":72,"status":30,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Advocate Christ Medical Center","Oak Lawn","Illinois","60453","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-87.75811,41.71087,{"lat":82,"lon":81},[85],{"name":68,"role":64,"phone":86,"phoneExt":30,"email":69},"414.219.7744",{"facility":88,"status":30,"city":89,"state":74,"zip":90,"country":76,"countryCode":77,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Advocate Lutheran General","Park Ridge","60068",{"type":79,"coordinates":92},[93,94],-87.84062,42.01114,{"lat":94,"lon":93},[97],{"name":98,"role":64,"phone":99,"phoneExt":30,"email":66},"Tara Albrecht, PhD","414-219-7744",{"facility":101,"status":30,"city":102,"state":103,"zip":104,"country":76,"countryCode":77,"cosmosGeoPoint":105,"geoPoint":109,"contacts":30},"Aurora St. Luke's Medical Center","Milwaukee","Wisconsin","53215",{"type":79,"coordinates":106},[107,108],-87.90647,43.0389,{"lat":108,"lon":107},{"type":111,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100655125","prevention-of-oral-mucositis-in-adults-in-with-hematologic-malignancy-100655125",false,"NCT07809984","Prevention of Oral Mucositis in Adults in With Hematologic Malignancy","Impact of Aloe Vera Mouthwash on the Prevention and Severity of Oral Mucositis in Adults in With Hematologic Malignancies","Inclusion Criteria:\n\n* Medical diagnosis of acute leukemia and receiving high or low intensity chemotherapy\n* English speaking\u002Freading (without an interpreter)\n* Access to a personal email address to support study participation\n\nExclusion Criteria:\n\n* Patients with preexisting mucositis.\n* Allergy to Aloe Vera\n* Transplant patients\n* Cognitively impaired or have a psychiatric condition that would prevent ability to provide informed consent\n* Pregnant women\n* Patients with an active eating disorder\n* Patients receiving end of life\u002Fhospice care","ALL","18 Years",{"count":122,"type":123},206,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this quasiexperimental cohort controlled intervention study is to learn if aloe vera mouthwash works better than usual care in the prevention and treatment of oral mucositis. Researchers will compare aloe vera to usual care. Participants in the intervention group will rinse their mouths with aloe vera 4 x\u002Fday for 28 days of their treatment. They will also complete questionnaires about oral health and mucositis.",[129,130,131,132],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Oral Mucositis",[134,135,136,137],"acute leukemia","supportive care","aloe vera","symptom management","NOT_YET_RECRUITING","2026-09-03",{"date":141,"type":142},"2026-09-09","ACTUAL",{"date":144,"type":123},"2026-10",{"date":146,"type":123},"2029-02",{"name":5,"class":6},3]