The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.
Chemotherapy-induced nausea and vomiting (CINV) is a serious complication of treatments of hematological malignancies. Although aprepitant has been shown to control CINV in highly emetogenic therapies for solid tumors, the antiemetic effect of aprepitant in hematological chemotherapies is still not clear. In this multi-central perspective randomized controlled study, the investigators are trying to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Tropisetron Hydrochloride Injection 5mg (Day 1-6)
Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)
Overall complete response (no emesis and no rescue therapy)
Time frame: During and post chemotherapy (0-120 h)
Time to initial neutrophil engraftment
Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10\^9/L
Time frame: 30 days post-transplantation
Time to initial platelet recovery
Time to initial platelet recovery is defined as 1st of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10\^9/L with no platelet transfusion in the prior 7 days.
Time frame: 30 days post-transplantation
Quality of Life
Time frame: During and post chemotherapy (0-120 h)
Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy.
Time frame: 30 days
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