Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- Woman's
- Study ID
- NCT07287826
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Oral Mucositis Due to Chemotherapy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dexamethasone Mouthwash — DRUGParticipants 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.
Study Details
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
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Mar 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: Dexamethasone Mouthwash Intervention GroupParticipants 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.
Primary Outcome Measure
Incidence of Grade ≥2 Oral Mucositis [ Time Frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks) ]
Central Contacts
- Jaymes H Collins, PhD225-924-7142
- Ericka Seidemann, MA225-231-5296
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Woman's Hospital | Baton Rouge | Louisiana | 70817 | Jaymes H Collins, PhD (PRINCIPAL_INVESTIGATOR) Mary R Salario, BSN, RN, CRN (PRINCIPAL_INVESTIGATOR) Lauren A Zatarain, MD (SUB_INVESTIGATOR) Brooke Coogan, MS (SUB_INVESTIGATOR) Elizabeth F Sutton, PhD (SUB_INVESTIGATOR) |