NCT07809984

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

2.2 years

First QC Date

September 3, 2026

Last Update Submit

September 3, 2026

Conditions

Acute LeukemiaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaOral Mucositis

Keywords

acute leukemiasupportive carealoe verasymptom management

Outcome Measures

Primary Outcomes (1)

  • Incidence of Oral Mucositis

    Number of participants that develop oral mucositis.

    Day 28

Secondary Outcomes (2)

  • Participants with Worsening Grade of Mucositis

    Day 28

  • Participants with Improving Grade of Mucositis

    Day 28

Other Outcomes (1)

  • Oral Mucositis Weekly Questionnaire Score

    Baseline and every 7 days for 28 days

Study Arms (2)

Phase 1 Usual Care

ACTIVE COMPARATOR

Participants in the usual care phase will receive standard of care

Other: Standard of Care

Phase 2 Intervention

EXPERIMENTAL

Participants in the intervention phase will receive aloe vera

Dietary Supplement: Aloe Vera Mouthwash

Interventions

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.

Phase 2 Intervention
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.

Phase 1 Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Advocate Lutheran General

Park Ridge, Illinois, 60068, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (10)

  • 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.

    PMID: 17377917BACKGROUND

  • Fidan 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: 34078546BACKGROUND

  • National 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

    BACKGROUND

  • 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.

    PMID: 38933098BACKGROUND

  • Steinmann 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: 33467951BACKGROUND

  • Shadish W, Cook T, Campbell D. Quasi-experimental designs that use both control groups and pretests. In: Experimental and Quasi-Experimental Designs.; 2002:161.

    BACKGROUND

  • 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.

    PMID: 36109394BACKGROUND

  • Medina 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.

    PMID: 38921709BACKGROUND

  • Elad 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.

    PMID: 32786044BACKGROUND

  • Brown 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.

    PMID: 32048926BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaStomatitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Tara Albrecht, PhD, ACNP-BC, ACHPN, RN

    Advocate Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Albrecht, PhD, ACNP-BC, ACHPN, RN

CONTACT

336.716.9619tara.albrecht@aah.org

Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt

CONTACT

336.716.9619Jeanne.hlebichuk@aah.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study will apply a quasiexperimental cohort-controlled design. Phase 1 will enroll usual care group and Phase 2 will enroll intervention group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

To protect participants identity, we are not able to share individual participant data

Locations

US(3)