A Phase 4 interventional study of Dexamethasone Mouthwash in Oral Mucositis Due to Chemotherapy, sponsored by Woman's. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Woman's · Phase 4, Interventional, and Prevention
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
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.
Risks related to the intervention are expected to be minimal and may include oral thrush, burning sensation, or changes in taste. Dexamethasone is generally well tolerated in topical formulations, and safety monitoring will focus on local and systemic reactions potentially linked to steroid use.
There is no cost to participate in the study. All study activities are conducted as part of routine care at Woman's Cancer Pavilion. The study is funded by a grant from the Foundation for Woman's.
This study will not collect biospecimens. No genetic testing will be performed. Only de-identified data will be used in any publication or external reporting. Identifiable information from the prospective and historical cohorts will be stored securely in compliance with institutional and federal regulations.
This research aims to generate evidence to support proactive, standardized interventions to prevent chemotherapy-induced oral mucositis and improve supportive care for patients undergoing cancer treatment.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Woman's is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Incidence of Grade ≥2 Oral Mucositis
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.
Time frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Severity of Oral Mucositis Symptoms (Clinician Assessed)
Severity of oral mucositis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) grading scale.
Time frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Severity of Oral Mucositis Symptoms (Patient-Reported)
Participants will report symptoms using the Oral Mucositis Weekly Questionnaire (OMWQ), which includes ratings for mouth and throat soreness, pain, and interference with eating, drinking, and speaking.
Time frame: From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks)
Chemotherapy Treatment Modifications Due to Oral Mucositis
Number of chemotherapy dose delays, reductions, or discontinuations that are documented as being caused by oral mucositis symptoms.
Time frame: Up to 16 weeks
Number of Participants With Adverse Events Related to Dexamethasone Mouthwash
Number of participants who experience at least one adverse event (AE) deemed related to mouthwash use, including but not limited to oral candidiasis or allergic response.
Time frame: Up to 16 weeks
Mouthwash Adherence
Self-reported and staff-monitored adherence to the prescribed mouthwash use protocol.
Time frame: Daily for the first 8 weeks of chemotherapy
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — At this time, it is not yet known whether individual participant data (IPD) from this study will be shared. If shared, the IPD may include de-identified data sets containing clinical outcomes such as oral mucositis severity, adverse events, and participant-reported symptom scores. A final decision will be based on privacy protections, data use agreements, and institutional policies related to secondary data sharing.
Started Apr 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.
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