Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy (SMILE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis Due to Chemotherapy
• Intervention / Treatment: Drug: Dexamethasone Mouthwash

Detailed Description

Oral mucositis is a common and painful side effect of chemotherapy, particularly in patients receiving regimens such as anthracyclines and taxanes. It can lead to difficulty eating, drinking, and speaking, and may result in treatment delays or dose reductions. Recent studies suggest that prophylactic use of dexamethasone mouthwash may reduce the incidence and severity of chemotherapy-induced oral mucositis. However, optimal dosing schedules and broader applicability across cancer types remain unclear.

The SMILE Study is a single-arm, prospective clinical trial designed to evaluate the effectiveness of dexamethasone mouthwash in preventing oral mucositis in adults receiving specific types of chemotherapy for cancer. Participants will be enrolled before beginning chemotherapy regimens known to be associated with a high risk of mucositis. All participants will receive dexamethasone mouthwash to use as a swish-and-spit rinse for 8 weeks.

The study will enroll at least 45 participants. Participants will be monitored throughout their chemotherapy treatment for signs and symptoms of oral mucositis, treatment adherence, and potential adverse events related to the mouthwash. Patient-reported outcomes will be collected using the Oral Mucositis Weekly Questionnaire (OMWQ), administered at routine infusion visits. Data on chemotherapy dose modifications or delays will also be recorded.

To assess effectiveness, the outcomes from the prospective cohort will be compared to a retrospective historical control group composed of patients previously treated at the same facility with similar chemotherapy regimens but who did not receive dexamethasone mouthwash. Data from the control group will be collected from the electronic medical record (EMR) and will include oral mucositis incidence and severity, chemotherapy regimens, and any treatment delays due to mucositis. Matching or statistical adjustment methods (e.g., multivariable regression) may be used to account for confounding variables.

The primary endpoint is the incidence of grade ≥2 oral mucositis during chemotherapy, graded per CTCAE v5.0. Secondary endpoints include overall mucositis severity, chemotherapy delays or reductions, patient-reported symptoms (pain, discomfort, interference with eating or speaking), and adherence to mouthwash use.

Risks related to the intervention are expected to be minimal and may include oral thrush, burning sensation, or changes in taste. Dexamethasone is generally well tolerated in topical formulations, and safety monitoring will focus on local and systemic reactions potentially linked to steroid use.

There is no cost to participate in the study. All study activities are conducted as part of routine care at Woman's Cancer Pavilion. The study is funded by a grant from the Foundation for Woman's.

This study will not collect biospecimens. No genetic testing will be performed. Only de-identified data will be used in any publication or external reporting. Identifiable information from the prospective and historical cohorts will be stored securely in compliance with institutional and federal regulations.

This research aims to generate evidence to support proactive, standardized interventions to prevent chemotherapy-induced oral mucositis and improve supportive care for patients undergoing cancer treatment.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jaymes H Collins, PhD; Phone Number: 225-924-7142; Email: hunter.collins@womans.org
• Study Contact Backup: Name: Ericka Seidemann, MA; Phone Number: 225-231-5296; Email: research@womans.org

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Recruiting
      • Woman's Hospital
      • Contact: Jaymes H Collins, PhD; Phone Number: 225-924-7142; Email: hunter.collins@womans.org
      • Contact: Ericka Seidemann, MA; Phone Number: 225-231-5296; Email: research@womans.org
      • Principal Investigator: Jaymes H Collins, PhD
      • Principal Investigator: Mary R Salario, BSN, RN, CRN
      • Sub-Investigator: Lauren A Zatarain, MD
      • Sub-Investigator: Brooke Coogan, MS
      • Sub-Investigator: Elizabeth F Sutton, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Dexamethasone Mouthwash; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade ≥2 Oral Mucositis	Proportion of participants who develop grade 2 or higher oral mucositis, as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0), during chemotherapy treatment while using dexamethasone mouthwash.	From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Oral Mucositis Symptoms (Clinician Assessed)	Severity of oral mucositis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) grading scale.	From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Severity of Oral Mucositis Symptoms (Patient-Reported)	Participants will report symptoms using the Oral Mucositis Weekly Questionnaire (OMWQ), which includes ratings for mouth and throat soreness, pain, and interference with eating, drinking, and speaking.	From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks)
Chemotherapy Treatment Modifications Due to Oral Mucositis	Number of chemotherapy dose delays, reductions, or discontinuations that are documented as being caused by oral mucositis symptoms.	Up to 16 weeks
Number of Participants With Adverse Events Related to Dexamethasone Mouthwash	Number of participants who experience at least one adverse event (AE) deemed related to mouthwash use, including but not limited to oral candidiasis or allergic response.	Up to 16 weeks
Mouthwash Adherence	Self-reported and staff-monitored adherence to the prescribed mouthwash use protocol.	Daily for the first 8 weeks of chemotherapy

Collaborators and Investigators

• Sponsor: Woman's
• Investigators: Principal Investigator: Jaymes H Collins, PhD, Woman's Hospital, Louisiana

Publications and helpful links

General Publications

• Saigal B, Guerra L. Prevention of Stomatitis: Using Dexamethasone-Based Mouthwash to Inhibit Everolimus-Related Stomatitis. Clin J Oncol Nurs. 2018 Apr 1;22(2):211-217. doi: 10.1188/18.CJON.211-217.
• Kuderer NM, Desai A, Lustberg MB, Lyman GH. Mitigating acute chemotherapy-associated adverse events in patients with cancer. Nat Rev Clin Oncol. 2022 Nov;19(11):681-697. doi: 10.1038/s41571-022-00685-3. Epub 2022 Oct 11.
• Ruddy KJ, Zahrieh D, He J, Waechter B, Holleran JL, Lewis LD, Chow S, Beumer J, Weiss M, Trikalinos N, Faller B, Lustberg M, Rugo HS, Loprinzi C. Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701). Semin Oncol. 2023 Feb-Apr;50(1-2):7-10. doi: 10.1053/j.seminoncol.2023.01.001. Epub 2023 Jan 17.
• Kuba S, Maeda S, Shibata K, Soutome S, Yamanouchi K, Matsumoto M, Tanaka A, Morita M, Hatachi T, Otsubo R, Yano H, Kawashita Y, Sato S, Taniguchi H, Kanetaka K, Umeda M, Nagayasu T, Eguchi S. EFFICACY AND SAFETY OF A DEXAMETHASONE-BASED MOUTHWASH TO PREVENT CHEMOTHERAPY-INDUCED STOMATITIS IN WOMEN WITH BREAST CANCER: A MULTICENTRE, OPEN-LABEL, RANDOMISED PHASE 2 STUDY. J Evid Based Dent Pract. 2023 Sep;23(3):101896. doi: 10.1016/j.jebdp.2023.101896. Epub 2023 Jun 11.
• Rugo HS, Seneviratne L, Beck JT, Glaspy JA, Peguero JA, Pluard TJ, Dhillon N, Hwang LC, Nangia C, Mayer IA, Meiller TF, Chambers MS, Sweetman RW, Sabo JR, Litton JK. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. Lancet Oncol. 2017 May;18(5):654-662. doi: 10.1016/S1470-2045(17)30109-2. Epub 2017 Mar 15.
• Seiler S,Kosse J,Loibl S,Jackisch C

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: oral mucositis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis
• Other Study ID Numbers: RP-25-033-WH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, it is not yet known whether individual participant data (IPD) from this study will be shared. If shared, the IPD may include de-identified data sets containing clinical outcomes such as oral mucositis severity, adverse events, and participant-reported symptom scores. A final decision will be based on privacy protections, data use agreements, and institutional policies related to secondary data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No