Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement
A Phase III Trial Comparing Efficacy and Safety of Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
212
125mg D1, 80mg D2-3
15mg D2-4
Fudan University Cancer Hospital
Shanghai, China
Delayed emesis control (no vomiting and no rescue treatment during 25-120 hours after initiation of chemotherapy)
Time frame: 6 days
To assess safety of treatment group and control group. (number of participants with adverse events)
Time frame: 9 weeks
To assess appetite improvement after adding Mirtazapine treatment by using Food Diary.
Time frame: 9 weeks
To assess complete response (CR) rate during 0-24 hours after initiation of chemotherapy, to examine differences in acute emesis control after adding Aprepitant treatment.
Time frame: 24 hours
To assess complete response (CR) rate during 0-120 hours after initiation of chemotherapy.
Time frame: 120 hours
no rescue antiemetic therapy in 0-24 hours, 0-120 hours and 25-120 hours after initiation of chemotherapy
Time frame: 24 hours; 120 hours
time to first vomiting episode, time to first rescue antiemetic therapy and time to treatment failure (based on first vomiting episode or first rescue antiemetic therapy, whichever occurs first)
Time frame: 9 weeks
To assess the impact on patients' daily life activities in both acute and delayed emesis phases after chemotherapy by using the Functional Living Index -Emesis (FLIE).
Time frame: 120 hours
To assess impact of nausea and vomiting on compliance of patients receiving chemotherapy.
Time frame: 9 weeks
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