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

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.

Conditions

• Neoplasms

Interventions

DRUG

Thalidomide

100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1

DRUG

Placebo for thalidomide

Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1

DRUG

Palonosetron and Dexamethasone

Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.

Sponsors & Collaborators

• The First Hospital of Liaoning Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• General Hospital of Shenyang Military Region

  collaborator OTHER

• Liaoyang Central Hospital

  collaborator OTHER

• Third People's hospital Liaoyang

  collaborator OTHER

• Petrochemical General Hospital of Liaoyang city

  collaborator UNKNOWN

• Anshan Tumor Hospital

  collaborator OTHER

• China Medical University, China

  lead OTHER

Principal Investigators

• Yunpeng Liu, MD., PhD · China Medical University, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2016-07-31

Completion

2016-08-31

Countries

• China

Study Locations