Recruiting

Dexamethasone

Sponsor:

Woman's

Code:

NCT07287826

Conditions

Oral Mucositis Due to Chemotherapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone Mouthwash

Study Details

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

Conditions

Oral Mucositis Due to Chemotherapy

Study ID

NCT07287826

Start date

Apr 2, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Incidence of Grade ≥2 Oral Mucositis [ Time Frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks) ]

Central Contacts and Locations

Central contacts

Ashley R Edwards, PhD

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

Ericka Seidemann, MA

225-231-5296ERICKA.SEIDEMANN@womans.org

Locations

Woman's Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Ashley R Edwards, PhD

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

Ericka Seidemann, MA

225-231-5296ERICKA.SEIDEMANN@womans.org

Principal Investigator:

Ashley R Edwards, PhD

More Information

Sponsor

Woman's

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • oral mucositis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Woman's on 2026-06-25.