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

Trial Summary

What is the purpose of this trial?

TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive (\[HR+\], estrogen receptor and/or progesterone receptor positive) breast cancer (BC), or advanced/metastatic triple negative breast cancer (TNBC) or (Cohort 2:) advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). All patients will be treated with Datopotumab deruxtecan (Dato-DXd) at 6 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity. Due to the risk of stomatitis, the investigational component of this trial will be to incorporate alcohol-free dexamethasone mouthwash, 10 mL 0.5 mg/5mL oral solution, days 1-5, swish and spit four times daily for the first 3 cycles.

Research Team

Stephanie Graff, MD

Principal Investigator

Rhode Island and the Miriam Hospitals (Brown University Health)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+