Dexamethasone Mouthwash for Mucositis
(SMILE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a steroid mouthwash called dexamethasone can prevent painful mouth sores in cancer patients undergoing chemotherapy. Researchers aim to determine if the mouthwash reduces the likelihood of sores and makes chemotherapy more comfortable. Participants will use the mouthwash four times daily for up to 8 weeks and complete short surveys about their mouth discomfort. The trial seeks adults with cancer who are beginning chemotherapy treatments known to cause mouth sores. As a Phase 4 trial, this research explores how the already FDA-approved and effective treatment benefits a broader patient population.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for this treatment?
Research shows that dexamethasone mouthwash is generally safe for people undergoing chemotherapy. Studies have found that this mouthwash effectively reduces the severity of mouth sores, or stomatitis, in patients with early breast cancer receiving chemotherapy. Importantly, these studies reported that patients tolerate the mouthwash well.
Trials where patients regularly used dexamethasone mouthwash showed fewer and less severe mouth sores without significant side effects. This suggests that the mouthwash is a safe option for managing mouth discomfort related to chemotherapy.12345Why are researchers enthusiastic about this study treatment?
Most treatments for oral mucositis, a common side effect of chemotherapy, focus on pain management and include options like oral rinses or topical anesthetics. However, dexamethasone mouthwash stands out because it uses an anti-inflammatory steroid known to reduce swelling and irritation directly in the mouth. This mouthwash is alcohol-free, making it a gentle option for sensitive oral tissues. Researchers are excited about its potential to not only alleviate symptoms but also reduce the severity of mucositis, offering a proactive approach rather than just symptom relief.
What evidence suggests that dexamethasone mouthwash might be an effective treatment for mucositis?
Research shows that dexamethasone mouthwash can reduce mouth sores caused by chemotherapy. Studies have found that this mouthwash decreases the frequency and severity of these painful sores. In one study, all patients experienced a noticeable reduction in the severity of their mouth sores after using the mouthwash. Another study found that dexamethasone mouthwash significantly reduced sores in patients receiving cancer treatment for the head and neck. In this trial, participants in the Dexamethasone Mouthwash Intervention Group will use an alcohol-free dexamethasone mouthwash to potentially make chemotherapy more comfortable by preventing painful mouth issues.36789
Who Is on the Research Team?
Jaymes H Collins, PhD
Principal Investigator
Woman's Hospital, Louisiana
Are You a Good Fit for This Trial?
This trial is for adults with cancer who are undergoing chemotherapy and at risk of developing mouth sores. Participants will use a steroid mouthwash during their treatment period to see if it helps prevent these sores.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a steroid mouthwash (dexamethasone) four times daily during chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Trial Overview
The study tests whether dexamethasone mouthwash, used four times daily before and during chemotherapy for up to 8 weeks, can reduce the occurrence of moderate to severe mouth sores compared to past patients who didn't use it.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Woman's
Lead Sponsor
Citations
Using a Steroid Mouthwash to Prevent Mouth Sores During ...
Recent studies suggest that prophylactic use of dexamethasone mouthwash may reduce the incidence and severity of chemotherapy-induced oral ...
Efficacy and Safety of Topical Steroid Therapy for Oral ...
Dexamethasone mouthwash was used in 14 patients on various anticancer therapies. Reported as safe and effective, but lacked a control group and ...
Effectiveness and safety of a novel dexamethasone ...
All patients achieved a significant reduction in the severity of stomatitis after starting the dexamethasone mouthwash formulation. In both cohorts, ...
Prevention of chemoradiation-related mucositis in patients ...
Conclusions. Dexamethasone-based solution mouthwash significantly reduced the incidence and severity of oral mucositis in head and neck cancer patients ...
Study for Dexamethasone Mouthwash in Lowering ...
effectiveness of prophylactic dexamethasone mouthwash in reducing oral mucositis among patients with cancer receiving chemotherapy ...
Efficacy and safety of dexamethasone-based mouthwash ...
Dexamethasone-based mouthwash safely reduced the incidence and severity of stomatitis in patients receiving chemotherapy (EC/TC) for early breast cancer.
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jnjmedicalconnect.com
jnjmedicalconnect.com/products/rybrevant/medical-content/safety-information-for-rybrevant-management-of-oral-mucositisManagement of Oral Mucositis - RYBREVANT®
A summary of safety data regarding the management of oral mucositis in patients treated with RYBREVANT® (amivantamab-vmjw).
Dexamethasone to prevent everolimus-induced stomatitis ...
Two patients (11.1%) on the placebo arm reported at least one grade 3 non-hematologic adverse event (lower gastrointestinal hemorrhage, and oral mucositis), ...
original article efficacy and safety of a dexamethasone ...
The dexamethasone-based mouthwash safely reduced stomatitis incidence and severity in patients receiving chemotherapy for early breast cancer.
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