Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting

Neoplasms Clinical Trial

Official title: Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial

Status Completed

Clinical Trial Summary

This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.

Clinical Trial Description

This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the study. Patients treating with highly emetogenic chemotherapy will be randomized into two groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo + Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate (CRR) for delayed CINV, and the secondary end points include the safety and quality of life (QOL). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Neoplasms
• Vomiting

• NCT number: NCT02203253
• Study type: Interventional
• Source: China Medical University, China
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Completion date: August 2016