Acute LeukemiaNCT07809984
Prevention of Oral Mucositis in Adults in With Hematologic Malignancy
A study testing Aloe Vera Mouthwash in people with Acute Leukemia and Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Aloe Vera Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2027to Feb 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt, 414.219.7744, Jeanne.hlebichuk@aah.org
Advocate Lutheran General
Park Ridge, Illinois, 60068
Tara Albrecht, PhD, 414-219-7744, tara.albrecht@aah.org
About this study
Official title: Impact of Aloe Vera Mouthwash on the Prevention and Severity of Oral Mucositis in Adults in With Hematologic Malignancies
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.
Read the detailed description
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).
- Being tested
- Aloe Vera Mouthwash, Standard of Care
- Keywords
- acute leukemia, supportive care, aloe vera, symptom management
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe Vera MouthwashDietary supplement
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Usual Care | Active comparator | Participants in the usual care phase will receive standard of care Receives: Other: Standard of Care |
| Phase 2 Intervention | Experimental | Participants in the intervention phase will receive aloe vera Receives: Dietary Supplement: Aloe Vera Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Oral Mucositis
Number of participants that develop oral mucositis.
Measured: Day 28
Secondary outcomes (2)
Participants with Worsening Grade of Mucositis
Number of participants with worsening grade of mucositis.
Measured: Day 28
Participants with Improving Grade of Mucositis
Number of participants with improving grade of mucositis.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study will apply a quasiexperimental cohort-controlled design. Phase 1 will enroll usual care group and Phase 2 will enroll intervention group.
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara Albrecht, PhD, ACNP-BC, ACHPN, RN, Principal investigator, Advocate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809984
- Sponsor's protocol ID
- IRB00155690
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participants identity, we are not able to share individual participant data
Publications
Epstein 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.
PubMed 17377917Fidan 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.
PubMed 34078546National 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
Abdalla-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.
PubMed 38933098Steinmann 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.
PubMed 33467951Shadish W, Cook T, Campbell D. Quasi-experimental designs that use both control groups and pretests. In: Experimental and Quasi-Experimental Designs.; 2002:161.
Gundogdu F, Sayar S. Oncology nursing practices in the management of chemotherapy-related oral mucositis in accordance with evidence-based guidelines: a descriptive and cross-sectional study. Support Care Cancer. 2022 Nov;30(11):9549-9557. doi: 10.1007/s00520-022-07361-3. Epub 2022 Sep 16.
PubMed 36109394Medina Cruz E, Palenzuela Luis N, Rodriguez Novo N, Gonzalez Suarez M, Casas Hernandez R, Novo Munoz MM. Instruments for Evaluating the Nutritional Status of Cancer Patients Undergoing Antineoplastic Treatment: A Scoping Review. Nurs Rep. 2024 May 23;14(2):1312-1323. doi: 10.3390/nursrep14020099.
PubMed 38921709Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
PubMed 32786044Brown TJ, Gupta A. Management of Cancer Therapy-Associated Oral Mucositis. JCO Oncol Pract. 2020 Mar;16(3):103-109. doi: 10.1200/JOP.19.00652. Epub 2020 Feb 3.
PubMed 32048926