Preventing Stomatitis with Dexamethasone Mouthwash in Dato-DXd Treatment
This study is looking at whether a dexamethasone mouthwash can help prevent stomatitis (mouth sores) in people receiving a cancer treatment called Datopotamab Deruxtecan (Dato-DXd). You might be able to join if you have advanced breast cancer (either hormone-receptor positive, triple negative, or HER2-positive) or advanced non-small cell lung cancer that has progressed after other treatments. All participants will receive Dato-DXd and use the dexamethasone mouthwash. The main goal is to see if the mouthwash lowers the number of people who get stomatitis over about 9 weeks. This study plans to include 60 people, but its current recruitment status is unclear.
- Study design
- This is a Phase 2 interventional study with two groups of participants, analyzed together. It plans to enroll 60 adult patients.
- What's involved
- You would receive Datopotamab Deruxtecan intravenously (IV) every 3 weeks and use dexamethasone mouthwash daily for the first 5 days of the first three cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for stomatitis is measured at approximately 9 weeks.
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NCT06974604
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Recruiting
PHASE2Ages 18+InterventionalTreatmentBrown UniversityInvestigator-initiated
~60 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:Dexamethasone oral
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lower the incidence of all stomatitis
Measured over Approximately 9 weeks
Conditions
Where it's being run
1 sites across 1 statesRhode Island1
Study leadership
- Stephanie Graff, MD · PRINCIPAL_INVESTIGATOR · Rhode Island and the Miriam Hospitals (Brown University Health)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Has advanced and/or metastatic cancer that meets one of the following criteria:
Aged ≥18 years.
Has an Eastern Cooperative Oncology Group performance status 0-2.
Has a left ventricular ejection fraction (LVEF) 50% by either an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 28 days before enrollment.
Measurable disease based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.
Has adequate organ function that would make them an appropriate candidate for Datopotamab deruxtecan therapy as treatment of advanced metastatic cancer as assessed by the treating physician, which shall include results of complete blood count with differential, and comprehensive metabolic panel within 14 days before Cycle 1, Day 1, defined as:
Has an adequate treatment washout period prior to Cycle 1, Day 1, defined as appropriately recovering from:
If of reproductive/child-bearing potential, agrees to use a highly effective form of contraception or avoid intercourse throughout treatment and upon completion of the study for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective methods of birth control include: combined (estrogen and progesterone containing) hormonal contraception by oral or intravaginal route or dermal patches; progesterone-only hormonal contraception associated with inhibition of ovulation given by oral route or by injections or implants; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (with confirmation of surgical success); and complete heterosexual abstinence.
Starting at the time of randomization/first dose of study intervention male subjects/participants must not freeze or donate sperm at any time during this study and for at least 4 months after the last dose of Dato-DXd. Preservation of sperm should be considered prior to randomization/first dose of study intervention.
Starting at the time of randomization/first dose of study intervention female subjects/participants must not breastfeed or donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of Dato-DXd. Preservation of ova should be considered prior to randomization/first dose of study intervention.
Is able to provide written informed consent and is willing and able to comply with the protocol. Subject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible toxicities) and must sign and date the Institutional Review Board (IRB)/Independent ethics committee (IEC) approved informed consent form (ICF) (including Health Insurance Portability and Accountability Act authorization \[HIPAA\], if applicable) before performance of any study- specific procedures or examinations.
Willingness to self-report level of oral pain using Visual Analog Scale (VAS) and the Normalcy Diet Scale (NDS) throughout each stomatitis event. (40, 41) At baseline, patient's self-reported oral pain level, using VAS, must be 0 (See Appendix B) and the normalcy diet scale score should ≥ 60 (See Appendix C).
Willingness to record oral symptoms in Oral Diary (See Appendix D).
Has a life expectancy of ≥3 months.
Exclusion
Active second malignancy which would alter interpretation of study results.
Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Has clinically significant corneal disease
Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
Has ongoing radiation-related toxicities
Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
Has active human immunodeficiency virus (HIV) infection that is not well controlled.
Has an active or uncontrolled hepatitis B and/or hepatitis C infection
Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment.
Clinically severe pulmonary compromise resulting from autoimmune, connective tissue or inflammatory disorders with pulmonary involvement.
Has uncontrolled or significant cardiac disease (including MI or unstable angina within the past 6 months, NYHA Class II-IV heart failure, uncontrolled hypertension, uncontrolled or significant arrhythmia).
History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
What this trial measures
- Lower the incidence of all stomatitisApproximately 9 weeks
Lower the incidence of all stomatitis by 20%