Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy
ConditionOral Mucositis Due to Chemotherapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWoman's
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Dexamethasone Mouthwash
DrugParticipants 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Dexamethasone Mouthwash Intervention GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)Secondary outcomes
1
Severity of Oral Mucositis Symptoms (Clinician Assessed)
Severity of oral mucositis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) grading scale.
Time frame
From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)2
Severity of Oral Mucositis Symptoms (Patient-Reported)
Participants will report symptoms using the Oral Mucositis Weekly Questionnaire (OMWQ), which includes ratings for mouth and throat soreness, pain, and interference with eating, drinking, and speaking.
Time frame
From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks)3
Chemotherapy Treatment Modifications Due to Oral Mucositis
Number of chemotherapy dose delays, reductions, or discontinuations that are documented as being caused by oral mucositis symptoms.
Time frame
Up to 16 weeks4
Number of Participants With Adverse Events Related to Dexamethasone Mouthwash
Number of participants who experience at least one adverse event (AE) deemed related to mouthwash use, including but not limited to oral candidiasis or allergic response.
Time frame
Up to 16 weeks Source ClinicalTrials.gov