Dexamethasone mouthwash to prevent chemotherapy-related mouth sores

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Woman's Hospital
  Baton Rouge, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Ashley R Edwards, PhD — Woman's Hospital, Louisiana
• Study coordinator: Ashley R Edwards, PhD
• Email: ashley.edwards@womans.org
• Phone: 225-421-9185

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Copaiba Mouthwash with Low-Level Laser Therapy to Prevent Mouth Sores After Stem Cell Transplant

  This phase 2 trial tests whether a copaíba-based mouthwash, used four times daily, can help prevent oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation.

  Recruiting Phase 2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT07810530

• Ozone gas plus biomimetic toothpaste and mouthwash to treat cancer therapy mouth sores

  This trial will test whether adding a biomimetic toothpaste and mouthwash to ozone gas therapy helps adults with chemo- or radiotherapy-induced mouth sores heal faster and have less pain.

  Recruiting University of Pavia · Pavia, Lombardy · NCT07491536

• Chlorophyllin to reduce mouth sores before allogeneic stem cell transplant

  This phase II study tests whether taking chlorophyllin by mouth can lower the chances and severity of mouth ulcers in patients aged 12–65 undergoing radiation-based conditioning before a first allogeneic stem cell transplant.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra · NCT07709195

• BupiZenge vs Lidocaine for mouth pain from oral mucositis in head and neck cancer

  A phase 3 trial tests whether the BupiZenge lozenge provides better pain relief than lidocaine for mouth sores caused by radiation in head and neck cancer patients.

  Recruiting at 9 sites Phase 3 OncoZenge AB · Copenhagen and 10 other locations · NCT07672236

• High-level laser therapy for oral mucositis in children receiving hematopoietic stem cell transplant

  This trial tests whether high-level laser therapy can reduce the pain and severity of oral mucositis in children undergoing hematopoietic stem cell (bone marrow) transplantation.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07436650

• Amimestrocel infusion to prevent severe mouth sores after allogeneic stem cell transplant

  This study will try a single IV infusion of Amimestrocel in adults receiving myeloablative allogeneic stem cell transplants with TBI or melphalan to see if it prevents severe mouth sores.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhu, Jiangsu · NCT07400328

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.