Study for Dexamethasone Mouthwash in Lowering Episodes of Oral Mucositis Among Patients With Cancer: The SMILE Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence of Grade ≥2 Oral Mucositis
研究概览
简要总结
The goal of this clinical trial is to learn if a steroid mouthwash (dexamethasone) can prevent mouth sores caused by chemotherapy in adults with cancer. The main questions it aims to answer are:
Does using dexamethasone mouthwash before and during chemotherapy lower the chance of getting moderate to severe mouth sores?
Can this approach reduce pain and improve comfort during chemotherapy?
Researchers will compare patients using the mouthwash to a historical group of patients who received similar chemotherapy but did not use the mouthwash, to see if the mouthwash helps prevent mouth sores.
Participants will:
Use a steroid mouthwash (4 times daily) for up to 8 weeks during chemotherapy
Complete a short weekly survey about mouth discomfort during infusion visits
详细描述
Oral mucositis is a common and painful side effect of chemotherapy, particularly in patients receiving regimens such as anthracyclines and taxanes. It can lead to difficulty eating, drinking, and speaking, and may result in treatment delays or dose reductions. Recent studies suggest that prophylactic use of dexamethasone mouthwash may reduce the incidence and severity of chemotherapy-induced oral mucositis. However, optimal dosing schedules and broader applicability across cancer types remain unclear.
The SMILE Study is a single-arm, prospective clinical trial designed to evaluate the effectiveness of dexamethasone mouthwash in preventing oral mucositis in adults receiving specific types of chemotherapy for cancer. Participants will be enrolled before beginning chemotherapy regimens known to be associated with a high risk of mucositis. All participants will receive dexamethasone mouthwash to use as a swish-and-spit rinse for 8 weeks.
The study will enroll at least 45 participants. Participants will be monitored throughout their chemotherapy treatment for signs and symptoms of oral mucositis, treatment adherence, and potential adverse events related to the mouthwash. Patient-reported outcomes will be collected using the Oral Mucositis Weekly Questionnaire (OMWQ), administered at routine infusion visits. Data on chemotherapy dose modifications or delays will also be recorded.
To assess effectiveness, the outcomes from the prospective cohort will be compared to a retrospective historical control group composed of patients previously treated at the same facility with similar chemotherapy regimens but who did not receive dexamethasone mouthwash. Data from the control group will be collected from the electronic medical record (EMR) and will include oral mucositis incidence and severity, chemotherapy regimens, and any treatment delays due to mucositis. Matching or statistical adjustment methods (e.g., multivariable regression) may be used to account for confounding variables.
The primary endpoint is the incidence of grade ≥2 oral mucositis during chemotherapy, graded per CTCAE v5.0. Secondary endpoints include overall mucositis severity, chemotherapy delays or reductions, patient-reported symptoms (pain, discomfort, interference with eating or speaking), and adherence to mouthwash use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Confirmed cancer diagnosis
- •Scheduled to receive or receiving chemotherapy known to be associated with oral mucositis (e.g., anthracyclines and taxanes)
- •Ability to provide informed consent
- •Ability to comply with study procedures
排除标准
- •Current tobacco usage or usage within the past 6 weeks.
- •Gastrointestinal disorder (such as Crohn's disease, ulcerative colitis, or celiac disease)
- •History of cold sores (herpes simplex virus)
- •Herpes zoster (oral shingles) within the past 6 weeks
- •Active oral infections at the time of enrollment (e.g., candidiasis)
- •Known sensitivity or allergy to dexamethasone
- •Inability to self-administer or tolerate mouthwash protocol
- •Concurrent enrollment in conflicting clinical trials
- •Existing oral ulcers or oral mucositis at enrollment
- •Uncontrolled diabetes mellitus as defined by HbA1c unknown or >8% in the past 3 months despite adequate therapy
研究组 & 干预措施
Dexamethasone Mouthwash Intervention Group
Participants in this arm will receive an alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL solution). They will be instructed to swish and spit 10 mL of the mouthwash for 2 minutes, four times daily, beginning in the first week of chemotherapy. Mouthwash use will continue for at least 8 weeks.
干预措施: Dexamethasone Mouthwash (Drug)
结局指标
主要结局
Incidence of Grade ≥2 Oral Mucositis
时间窗: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Proportion of participants who develop grade 2 or higher oral mucositis, as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0), during chemotherapy treatment while using dexamethasone mouthwash.
次要结局
- Chemotherapy Treatment Modifications Due to Oral Mucositis(Up to 16 weeks)
- Severity of Oral Mucositis Symptoms (Clinician Assessed)(From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks))
- Severity of Oral Mucositis Symptoms (Patient-Reported)(From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks))
- Number of Participants With Adverse Events Related to Dexamethasone Mouthwash(Up to 16 weeks)
- Mouthwash Adherence(Daily for the first 8 weeks of chemotherapy)