Prevention of Oral Mucositis in Adults in With Hematologic Malignancy
2026年9月3日 更新者：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.
研究概览
详细说明
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).
研究类型
介入性
注册 (估计的)
206
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Tara Albrecht, PhD, ACNP-BC, ACHPN, RN
- 电话号码：336.716.9619
- 邮箱：tara.albrecht@aah.org
研究联系人备份
- 姓名：Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt
- 电话号码：336.716.9619
- 邮箱：Jeanne.hlebichuk@aah.org
学习地点
-
-
Illinois
-
Oak Lawn、Illinois、美国、60453
- Advocate Christ Medical Center
-
接触：
- Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt
- 电话号码：414.219.7744
- 邮箱：Jeanne.hlebichuk@aah.org
-
Park Ridge、Illinois、美国、60068
- Advocate Lutheran General
-
接触：
- Tara Albrecht, PhD
- 电话号码：414-219-7744
- 邮箱：tara.albrecht@aah.org
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53215
- Aurora St. Luke's Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Oral Mucositis
大体时间：Day 28
|
Number of participants that develop oral mucositis.
|
Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participants with Worsening Grade of Mucositis
大体时间：Day 28
|
Number of participants with worsening grade of mucositis.
|
Day 28
|
|
Participants with Improving Grade of Mucositis
大体时间：Day 28
|
Number of participants with improving grade of mucositis.
|
Day 28
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oral Mucositis Weekly Questionnaire Score
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tara Albrecht, PhD, ACNP-BC, ACHPN, RN、Advocate Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2029年2月1日
研究注册日期
首次提交
2026年9月3日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00155690
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
To protect participants identity, we are not able to share individual participant data
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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