Dexamethasone Mouthwash for Oral Mucositis

Overseen By Stephanie Graff, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brown University

Must not be taking: Steroids, Monoclonal antibodies

Disqualifiers: Active malignancy, ILD, Corneal disease, Infection, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a dexamethasone mouthwash (a corticosteroid) can prevent or reduce oral mucositis (painful mouth sores) in patients treated for certain advanced or metastatic cancers, such as breast cancer and non-small cell lung cancer. The trial includes patients receiving Datopotumab deruxtecan, a cancer treatment that may cause stomatitis (mouth inflammation) as a side effect. Individuals with advanced breast or lung cancer that has progressed after prior treatments and who experience oral pain related to their cancer treatment might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) before starting the study drug. This includes stopping hormonal therapy, chemotherapy, and certain other treatments for at least 2 weeks, and longer for some specific drugs. It's best to discuss your current medications with the trial team to understand what changes might be needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that dexamethasone mouthwash is safe and effective in reducing stomatitis, which refers to painful swelling and sores inside the mouth, in patients undergoing chemotherapy for early breast cancer. Patients tolerated the mouthwash well and did not need to lower the dose or stop using it due to side effects. This suggests that dexamethasone mouthwash is generally safe for managing mouth sores. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for oral mucositis, which often include basic pain management and oral hygiene protocols, dexamethasone mouthwash offers a proactive approach by using a corticosteroid to reduce inflammation. Researchers are excited about this treatment because it is administered directly to the affected area, potentially decreasing the severity of symptoms more effectively than systemic treatments. This targeted delivery method allows the active ingredient, dexamethasone, to act quickly and locally, reducing the risk of systemic side effects common with oral or injectable corticosteroids.

What evidence suggests that dexamethasone mouthwash might be an effective treatment for oral mucositis?

Research has shown that dexamethasone mouthwash can reduce painful mouth sores in cancer patients. Studies have found that this mouthwash significantly decreases the number and severity of mouth sores in patients undergoing chemotherapy for early breast cancer. Another study found it effective for patients receiving combined chemotherapy and radiation for head and neck cancer. This trial will evaluate the effectiveness of dexamethasone mouthwash in managing mouth sores for patients undergoing cancer treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephanie Graff, MD

Principal Investigator

Rhode Island and the Miriam Hospitals (Brown University Health)

Are You a Good Fit for This Trial?

Adults with advanced breast cancer (either hormone-receptor positive or triple negative) or non-squamous non-small cell lung cancer can join. They'll be using a drug called Datopotumab deruxtecan and must not have conditions that could worsen with mouthwash use.

Inclusion Criteria

Has an adequate treatment washout period

If of reproductive/child-bearing potential, agrees to use highly effective contraception

Is able to provide written informed consent and comply with the protocol

Exclusion Criteria

Lactating or pregnant

Severe hypersensitivity reactions to other monoclonal antibodies

I am experiencing side effects from radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Datopotumab deruxtecan (Dato-DXd) at 6 mg/kg IV every 3 weeks and use dexamethasone mouthwash for the first 3 cycles

9 weeks

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The trial tests if an alcohol-free dexamethasone mouthwash can prevent stomatitis, a common painful mouth sore side effect of the cancer drug Dato-DXd. Patients will swish and spit this mouthwash during their first three treatment cycles.

How Is the Trial Designed?

Group I: Dexamethasone 10mL Experimental Treatment 1 Intervention

Prophylactic oral dexamethasone

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.12103

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9307799/

Impact of systemic dexamethasone administration on oral ... Our study suggests that DEX attenuates OM in anthracycline-containing regimens for breast cancer treatment in a dose-dependent manner.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1532338223000817

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.

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)59936-7/fulltext

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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jop.13471

Dexamethasone solution and dexamethasone in Mucolox ... Dexamethasone 0.5 mg/5 mL in Mucolox™ was better tolerated and was slightly better in controlling patients' oral sensitivity. Larger studies are ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10247389/

Dexamethasone to prevent everolimus-induced stomatitis ... [15] In light of previous studies reporting low rates of severe mucositis when dexamethasone mouthwash is used during everolimus therapy, reactive use of ...

7. datrowayhcp.com datrowayhcp.com/managing-adverse-reactions

Adverse Reaction Management | DATROWAY® (datopotamab ... DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis. In the pooled safety population, stomatitis occurred in 63% of patients treated with ...

8. elsevier.es elsevier.es/es-revista-farmacia-hospitalaria-121-articulo-effectiveness-safety-novel-dexamethasone-mouthwash-S1130634323005755

Effectiveness and safety of a novel dexamethasone ... Dexamethasone mouthwash formulation was well tolerated and neither dose reduction nor discontinuation related to stomatitis was required.