Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy
NCT ID: NCT07287826
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
45 participants
INTERVENTIONAL
2026-01-31
2028-01-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Woman's
OTHER
Responsible Party
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Principal Investigators
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Jaymes H Collins, PhD
Role: PRINCIPAL_INVESTIGATOR
Woman's Hospital, Louisiana
Locations
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Woman's Hospital
Baton Rouge, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Jaymes H Collins, PhD
Role: primary
Ericka Seidemann, MA
Role: backup
References
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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.
Krishnaswamy V. A thin, flat, parallel plate ionization chamber for electron beam depth-dose measurements. Radiology. 1973 Oct;109(1):223-4. doi: 10.1148/109.1.223. No abstract available.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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RP-25-033-WH
Identifier Type: -
Identifier Source: org_study_id