NCT07287826

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Jan 2028

First Submitted

Initial submission to the registry

December 1, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

December 1, 2025

Last Update Submit

March 26, 2026

Conditions

Oral Mucositis Due to Chemotherapy

Keywords

oral mucositis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Severity of Oral Mucositis Symptoms (Clinician Assessed)

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

  • Severity of Oral Mucositis Symptoms (Patient-Reported)

    From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks)

  • Chemotherapy Treatment Modifications Due to Oral Mucositis

    Up to 16 weeks

  • Number of Participants With Adverse Events Related to Dexamethasone Mouthwash

    Up to 16 weeks

  • Mouthwash Adherence

    Daily for the first 8 weeks of chemotherapy

Study Arms (1)

Dexamethasone Mouthwash Intervention Group

EXPERIMENTAL

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

Interventions

Dexamethasone MouthwashDRUG

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.

Dexamethasone Mouthwash Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 29547614BACKGROUND

  • Seiler S,Kosse J,Loibl S,Jackisch C

    BACKGROUND

  • 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.

    PMID: 36221000BACKGROUND

  • 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.

    PMID: 36693773BACKGROUND

  • 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.

    PMID: 37689451BACKGROUND

  • 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.

    PMID: 28314691BACKGROUND

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Jaymes H Collins, PhD

    Woman's Hospital, Louisiana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaymes H Collins, PhD

CONTACT

225-924-7142hunter.collins@womans.org

Ericka Seidemann, MA

CONTACT

225-231-5296research@womans.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 17, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(1)