Clinical trial · Interventional
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
NCT07809984CI-TRIAL-00126154not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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/day for 28 days of their treatment. They will also complete questionnaires about oral health and mucositis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aloe Vera Mouthwash | Dietary Supplement | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Phase 1 Usual Care
- description
- Participants in the usual care phase will receive standard of care
- interventionNames
- Other: Standard of Care
- type
- EXPERIMENTAL
- label
- Phase 2 Intervention
- description
- Participants in the intervention phase will receive aloe vera
- interventionNames
- Dietary Supplement: Aloe Vera Mouthwash
Primary outcomes (1)
- measure
- Incidence of Oral Mucositis
- timeFrame
- Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Medical diagnosis of acute leukemia and receiving high or low intensity chemotherapy * English speaking/reading (without an interpreter) * Access to a personal email address to support study participation Exclusion Criteria: * Patients with preexisting mucositis. * Allergy to Aloe Vera * Transplant patients * Cognitively impaired or have a psychiatric condition that would prevent ability to provide informed consent * Pregnant women * Patients with an active eating disorder * Patients receiving end of life/hospice care
References
Publications (10)
- BACKGROUNDEpstein JB, Beaumont JL, Gwede CK, Murphy B, Garden AS, Meredith R, Le QT, Brizel D, Isitt J, Cella D. Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire. Cancer. 2007 May 1;109(9):1914-22. doi: 10.1002/cncr.22620. PMID 17377917
- BACKGROUNDFidan O, Arslan S. Development and Validation of the Oral Mucositis Risk Assessment Scale in Hematology Patients. Semin Oncol Nurs. 2021 Jun;37(3):151159. doi: 10.1016/j.soncn.2021.151159. Epub 2021 May 30. PMID 34078546
- BACKGROUNDNational Cancer Institute. (2017). Common toxicity criteria for adverse events (v. 5). https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf
- BACKGROUNDAbdalla-Aslan R, Bonomo P, Keefe D, Blijlevens N, Cao K, Cheung YT, Fregnani ER, Miller R, Raber-Durlacher J, Epstein J, Van Sebille Y, Kauark-Fontes E, Kandwal A, McCurdy-Franks E, Finkelstein J, McCarvell V, Zadik Y, Ottaviani G, Amaral Mendes R, Speksnijder CM, Wardill HR, Bossi P; MASCC Mucositis Study Group. Guidance on mucositis assessment from the MASCC Mucositis Study Group and ISOO: an international Delphi study. EClinicalMedicine. 2024 Jun 6;73:102675. doi: 10.1016/j.eclinm.2024.102675. eCollection 2024 Jul. PMID 38933098
- BACKGROUNDSteinmann D, Babadag Savas B, Felber S, Joy S, Mertens I, Cramer H, Paul A, Layer M, Klafke N, Stolz R, Heyder U, Neuberger P, Winkler M, Idler C, Heine R, Kaschdailewitsch E, John H, Schmeling B, Zielke T, Horneber M, Witt CM, Voiss P. Nursing Procedures for the Prevention and Treatment of Mucositis Induced by Cancer Therapies: Clinical Practice Guideline Based on an Interdisciplinary Consensus Process and a Systematic Literature Search. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420940412. doi: 10.1177/1534735420940412. PMID 33467951
- BACKGROUNDShadish W, Cook T, Campbell D. Quasi-experimental designs that use both control groups and pretests. In: Experimental and Quasi-Experimental Designs.; 2002:161.