NCT07287826 · Woman's
Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy
(SMILE)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Dexamethasone Mouthwash
Participants will use 10 mL of alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL) as a swish-and-spit rinse for 2 minutes, four times per day. Use will begin during the first week of chemotherapy and continue for at least 8 weeks.
Primary outcome measures
Incidence of Grade ≥2 Oral Mucositis
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥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
Exclusion criteria
- 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
Where
- Baton Rouge, Louisiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations