Dexamethasone mouthwash to prevent chemotherapy-related mouth sores

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

This trial tries a dexamethasone steroid mouthwash to prevent moderate-to-severe mouth sores in adults getting chemotherapy that can cause oral mucositis.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Woman's (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Baton Rouge, Louisiana)
• Trial ID: NCT07287826 on ClinicalTrials.gov

What this trial studies

The SMILE protocol is a single-arm, prospective Phase 4 study enrolling at least 45 adults scheduled to receive chemotherapy regimens with a high risk of oral mucositis (for example, anthracyclines and taxanes). All participants will self-administer a dexamethasone swish-and-spit mouthwash four times daily for up to eight weeks and complete a weekly Oral Mucositis Weekly Questionnaire at infusion visits. Study staff will record incidence and severity of mucositis, patient-reported oral pain and comfort, chemotherapy dose delays or reductions, adherence, and any mouthwash-related adverse events. Outcomes from the prospective cohort will be compared to a historical control group to estimate whether prophylactic dexamethasone reduces moderate-to-severe mucositis.

Who should consider this trial

Good fit: Adults aged 18 or older with a confirmed cancer diagnosis who are scheduled to receive or are receiving chemotherapy known to cause oral mucositis (such as anthracyclines or taxanes), who can provide consent and self-administer the mouthwash, are appropriate candidates.

Not a fit: Patients with active oral infections, recent herpes or shingles, current tobacco use, uncontrolled diabetes, pregnancy, known dexamethasone allergy, or those not receiving high-risk chemotherapy are unlikely to benefit from this mouthwash protocol.

Why it matters

Potential benefit: If successful, the mouthwash could reduce painful mouth sores, lessen oral pain, and help patients keep eating and stay on their planned chemotherapy schedule.

How similar studies have performed: Prior smaller studies and clinical reports have suggested prophylactic dexamethasone mouthwash can reduce chemotherapy-associated mucositis, but larger and more diverse validation is still limited.

Eligibility criteria

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 enrollment (e.g., candidiasis)
* Known sensitivity or allergy to dexamethasone
* Inability to self-administer or tolerate mouthwash protocol
* Concurrent enrollment in conflicting clinical trials
* Existing oral ulcers or oral mucositis at enrollment
* Pregnant
* Uncontrolled diabetes mellitus as defined by HbA1c unknown or \>8% in the past 3 months despite adequate therapy

Where this trial is running

Baton Rouge, Louisiana

• Woman's Hospital — Baton Rouge, Louisiana, United States (RECRUITING)

Study contacts

• Principal investigator: Jaymes H Collins, PhD — Woman's Hospital, Louisiana
• Study coordinator: Jaymes H Collins, PhD

Conditions: Oral Mucositis Due to Chemotherapy, oral mucositis