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Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy

NCT07287826 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-30

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Woman's

    lead OTHER

Principal Investigators

  • Jaymes H Collins, PhD · Woman's Hospital, Louisiana

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-07-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287826 on ClinicalTrials.gov