NCT02576327

A Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation

A Multi-central Perspective Randomized Controlled Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Jun Zhu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vomiting

Interventions

Type	Name	Description
DRUG	Tropisetron	Tropisetron Hydrochloride Injection 5mg (Day 1-6)
DRUG	Dexamethasone	Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
DRUG	Aprepitant	Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-10-15
• Last updated: 2016-12-30