Study for Dexamethasone Mouthwash in Lowering Episodes of Oral Mucositis Among Patients With Cancer: The SMILE Study
Woman's
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
Description
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 effecti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. * HIV/AIDS * 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…
Interventions
- DrugDexamethasone 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.
Location
- Woman's HospitalBaton Rouge, Louisiana