Prevention of Oral Mucositis in Adults in With Hematologic Malignancy
3. september 2026 opdateret af: Wake Forest University Health Sciences
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
206
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tara Albrecht, PhD, ACNP-BC, ACHPN, RN
- Telefonnummer: 336.716.9619
- E-mail: tara.albrecht@aah.org
Undersøgelse Kontakt Backup
- Navn: Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt
- Telefonnummer: 336.716.9619
- E-mail: Jeanne.hlebichuk@aah.org
Studiesteder
-
-
Illinois
-
Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Christ Medical Center
-
Kontakt:
- Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt
- Telefonnummer: 414.219.7744
- E-mail: Jeanne.hlebichuk@aah.org
-
Park Ridge, Illinois, Forenede Stater, 60068
- Advocate Lutheran General
-
Kontakt:
- Tara Albrecht, PhD
- Telefonnummer: 414-219-7744
- E-mail: tara.albrecht@aah.org
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Aurora St. Luke's Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Phase 1 Usual Care
Participants in the usual care phase will receive 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.
|
|
Eksperimentel: Phase 2 Intervention
Participants in the intervention phase will receive aloe vera
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Oral Mucositis
Tidsramme: Day 28
|
Number of participants that develop oral mucositis.
|
Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Participants with Worsening Grade of Mucositis
Tidsramme: Day 28
|
Number of participants with worsening grade of mucositis.
|
Day 28
|
|
Participants with Improving Grade of Mucositis
Tidsramme: Day 28
|
Number of participants with improving grade of mucositis.
|
Day 28
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oral Mucositis Weekly Questionnaire Score
Tidsramme: Baseline and every 7 days for 28 days
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Tara Albrecht, PhD, ACNP-BC, ACHPN, RN, Advocate Health
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Shadish 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. februar 2029
Datoer for studieregistrering
Først indsendt
3. september 2026
Først indsendt, der opfyldte QC-kriterier
3. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. september 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Mundsygdomme
- Stomatognatiske sygdomme
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukæmi, myeloid
- Leukæmi, lymfoid
- Leukæmi
- Hemiske og lymfatiske sygdomme
- Leukæmi, Myeloid, Akut
- Precursorcelle lymfoblastisk leukæmi-lymfom
- Stomatitis
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Sundhedskvalitet
- Kvalitetsindikatorer, sundhedsvæsenet
- Standard for pleje
Andre undersøgelses-id-numre
- IRB00155690
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
To protect participants identity, we are not able to share individual participant data
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