Clinical Trial

Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy

Study acronym: SMILE
Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 1 change
critical Recruitment opened 2026-03-31
Trial Details
NCT Number NCT07287826
Lead Sponsor Woman's
Conditions Oral Mucositis Due to Chemotherapy
Enrollment 45 participants
Start Date 2026-04-02
Primary Completion 2027-07 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-25