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Study for Dexamethasone Mouthwash in Lowering Episodes of Oral Mucositis Among Patients With Cancer: The SMILE Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
United States
Louisiana
Woman's Hospital
RECRUITING
Baton Rouge
Contact Information
Primary
Jaymes H Collins, PhD
hunter.collins@womans.org
225-924-7142
Backup
Ericka Seidemann, MA
research@womans.org
225-231-5296
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2028-01
Participants
Target number of participants: 45
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Woman's

This content was sourced from clinicaltrials.gov