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 — DRUG
    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.

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 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Woman's HospitalBaton RougeLouisiana70817
Jaymes H Collins, PhD
225-924-7142
Ericka Seidemann, MA
225-231-5296
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)

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