Dexamethasone Mouthwash for Mouth Sores
(TROPION-SWISH Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Will I have to stop taking my current medications?
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.
What is the safety track record for Dexamethasone mouthwash?
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.
Overall, dexamethasone mouthwash is safe and may help manage mouth sores related to cancer treatments.12345Why are researchers enthusiastic about this study treatment?
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.
What evidence suggests that dexamethasone mouthwash is effective for preventing mouth sores?
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
Are You a Good Fit for This Trial?
This trial is for patients with advanced breast cancer or EGFR-mutated non-small cell lung cancer that can't be removed by surgery. Participants should have mouth sores related to a drug called Dato-DXd and must not meet any exclusion criteria set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dato-DXd and prophylactic dexamethasone mouthwash to prevent stomatitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Safety Follow-up
Safety and tolerability of Dato-DXd are evaluated, including adverse events and laboratory assessments
What Are the Treatments Tested in This Trial?
Interventions
- Datopotamab Deruxtecan (Dato-DXd)
- Dexamethasone mouthwash
Trial Overview
The study tests if using dexamethasone mouthwash can prevent mouth sores in patients treated with Datopotamab Deruxtecan (Dato-DXd), an anti-cancer medication. It's an open-label, single-arm trial, meaning everyone gets the same treatment and knows what it is.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will use dexamethasone 0.5 mg/5 mL alcohol-free mouthwash (10 mL, 4 times daily, swish for approximately 2 minutes, then spit out without swallowing). Participants will remain without food or drink for at least 30 minutes after use of dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
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 mucositis.
Efficacy and safety of dexamethasone-based mouthwash ...
Conclusions: Dexamethasone-based mouthwash safely reduced the incidence and severity of stomatitis in patients receiving chemotherapy (EC/TC) ...
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.
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, ...
Study for Dexamethasone Mouthwash in Lowering ...
effectiveness of prophylactic dexamethasone mouthwash in reducing oral mucositis among patients with cancer receiving chemotherapy ...
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 ...
Dexamethasone to prevent everolimus-induced stomatitis ...
The results of this study do not suggest that prophylactic dexamethasone mouthwash is superior to therapeutic dexamethasone mouthwash.
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