Dexamethasone Mouthwash for Mouth Sores

(TROPION-SWISH Trial)

This trial tests whether a dexamethasone mouthwash can prevent mouth sores often caused by the cancer treatment Datopotamab Deruxtecan (Dato-DXd). It targets individuals with certain types of breast or lung cancer that have spread or cannot be surgically removed. The trial seeks participants who have not yet received Dato-DXd and are willing to use the mouthwash as directed. Eligible participants should have previously undergone specific cancer treatments, such as hormone therapy or chemotherapy, and must not have active mouth sores or allergies to steroids. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research shows that dexamethasone mouthwash is generally safe. Studies have found it reduces mouth sores in patients undergoing chemotherapy. Patients tolerated it well, without needing to lower the dose or discontinue use due to side effects.

However, the cancer drug Datopotamab Deruxtecan (Dato-DXd), which might be used with the mouthwash, has caused mouth sores in about 63% of patients. While the mouthwash is safe, Dato-DXd can still lead to some mouth problems.

Unlike other treatments for mouth sores, which often include topical anesthetics or oral medications, the dexamethasone mouthwash offers a unique delivery method. This alcohol-free mouthwash allows the active ingredient, dexamethasone, to directly target the sores, potentially reducing inflammation more effectively. Researchers are excited because this method could offer faster relief by swishing the solution directly where it's needed, without systemic side effects. Plus, the convenience of a mouthwash that fits easily into daily routines makes it a promising option for those seeking immediate comfort.

Studies have shown that dexamethasone mouthwash, used by participants in this trial, effectively reduces mouth sores caused by chemotherapy. Research indicates that this mouthwash decreases both the number and severity of these sores. For patients undergoing treatments like chemotherapy, this results in less discomfort and improved oral health. The mouthwash is generally safe and well-tolerated, helping manage a common side effect and making treatment more comfortable.¹²⁵⁶⁷