Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Trastuzumab Deruxtecan
Recruiting
Phase 3
Interventional Study
Nausea and Vomiting Caused by Trastuzumab Deruxtecan
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 74 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
This study aims to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by trastuzumab deruxtecan are non-inferior to the standard antiemetic regimen in breast cancer palliative therapy. Additionally, it will assess patients' appetite, gastrointestinal function, and other related indicators, and explore th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients must meet the following inclusion criteria for the study: \* Age ≥ 18 years and ≤ 85 years; \* Breast cancer patients scheduled to undergo palliative treatment with trastuzumab deruxtecan; \* ECOG performance status score of 0-2; \* Normal hematological function (plat…
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