NCT07287826 Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy
| NCT ID | NCT07287826 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Woman's |
| Condition | Oral Mucositis Due to Chemotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 45 participants in total. It began in 2026-04 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Jaymes H Collins, PhD
PRINCIPAL INVESTIGATOR
Woman's Hospital, Louisiana
Frequently Asked Questions
Who can join the NCT07287826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Mucositis Due to Chemotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07287826 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07287826 currently recruiting?
Yes, NCT07287826 is actively recruiting participants. Contact the research team at hunter.collins@womans.org for enrollment information.
Where is the NCT07287826 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT07287826 clinical trial?
NCT07287826 is sponsored by Woman's. The principal investigator is Jaymes H Collins, PhD at Woman's Hospital, Louisiana. The trial plans to enroll 45 participants.