RecruitingPhase 4

Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy

United States45 participantsStarted 2026-04-02

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Grade ≥2 Oral Mucositis

Timeframe: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)

Trial details

NCT IDNCT07287826

SponsorWoman's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Ashley R Edwards, PhD

225-421-9185 ashley.edwards@womans.org

View on ClinicalTrials.gov More Oral Mucositis Due to Chemotherapy trials