Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis. The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.
Official title: To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-15
Completion Date
2027-06-30
Last Updated
2025-11-28
Healthy Volunteers
No
Interventions
NEPA
On the first day, oral administration of NEPA(netopitan 300mg+ palonosetron 0.50mg)
Dexamethasone
On the first day, oral administration of dexamethasone 6mg; From the 2nd to the 4th day, take dexamethasone 3.75mg orally per day.
Megestrol Acetate
From the 1st to the 10th day, take 160mg of Megestrol Acetate orally per day.