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

Primary Purpose

Neoplasms

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Thalidomide
Placebo for thalidomide
Palonosetron and Dexamethasone
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring solid tumor, chemotherapy-induced delayed nausea and vomiting, thalidomide, prevention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18y ≤Age≤70y
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Histologically confirmed solid neoplasm
  • No prior chemotherapy
  • Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
  • Life expectancy of at least 12 weeks
  • Signed informed consent
  • For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment
  • Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide combination with doxorubicin/epirubicin

Exclusion Criteria:

  • Diabetic patients
  • Pregnant or lactated women
  • Patient with history of thrombosis
  • Concomitant radiotherapy
  • Known hypersensitivity to thalidomide, palonosetron, or dexamethasone.
  • Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs
  • CHOP regiment or taxanes-based regiment
  • Existing emesis within 24 hours before chemotherapy administration
  • Symptomatic brain metastasis or suspected clinical brain metastasis
  • Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy.
  • Inability to take or absorb oral medicine
  • Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
  • Unsuitable for the study or other chemotherapy determined by investigator

Sites / Locations

  • Anshan Tumor Hospital
  • Second Affiliated Hospital of Dalian Medical University
  • The First Affiliated Hospital of Dalian Medical University
  • The First Hospital of Liaoning Medical University
  • Liaoyang Central Hospital
  • Petrochemical General Hospital of Liaoyang city
  • Third People's hospital Liaoyang
  • The First Hospital of China Medical University
  • Shengjing Hospital of China Medical University
  • General Hospital of Shenyang Military Region
  • Liaoning Tumor Hospital & Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Thalidomide Group

Placebo Group

Arm Description

Thalidomide 100 mg by mouth twice a day on days 1-5; 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.

Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; 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.

Outcomes

Primary Outcome Measures

complete response rate (CRR) for delayed CINV

Secondary Outcome Measures

Adverse Events
quality of life

Full Information

First Posted
July 23, 2014
Last Updated
August 23, 2016
Sponsor
China Medical University, China
Collaborators
The First Hospital of Liaoning Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Tumor Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region, Liaoyang Central Hospital, Third People's hospital Liaoyang, Petrochemical General Hospital of Liaoyang city, Anshan Tumor Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02203253
Brief Title
Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
Collaborators
The First Hospital of Liaoning Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Tumor Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region, Liaoyang Central Hospital, Third People's hospital Liaoyang, Petrochemical General Hospital of Liaoyang city, Anshan Tumor Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
solid tumor, chemotherapy-induced delayed nausea and vomiting, thalidomide, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
642 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thalidomide Group
Arm Type
Active Comparator
Arm Description
Thalidomide 100 mg by mouth twice a day on days 1-5; 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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; 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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
Intervention Type
Drug
Intervention Name(s)
Placebo for thalidomide
Other Intervention Name(s)
Placebo tablet for thalidomide
Intervention Description
Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
Intervention Type
Drug
Intervention Name(s)
Palonosetron and Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
complete response rate (CRR) for delayed CINV
Time Frame
120 hours
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
Up to 3 weeks
Title
quality of life
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18y ≤Age≤70y Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Histologically confirmed solid neoplasm No prior chemotherapy Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L Life expectancy of at least 12 weeks Signed informed consent For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide combination with doxorubicin/epirubicin Exclusion Criteria: Diabetic patients Pregnant or lactated women Patient with history of thrombosis Concomitant radiotherapy Known hypersensitivity to thalidomide, palonosetron, or dexamethasone. Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs CHOP regiment or taxanes-based regiment Existing emesis within 24 hours before chemotherapy administration Symptomatic brain metastasis or suspected clinical brain metastasis Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy. Inability to take or absorb oral medicine Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment Unsuitable for the study or other chemotherapy determined by investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu, MD., PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anshan Tumor Hospital
City
Anshan
State/Province
Liaoning
Country
China
Facility Name
Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of Liaoning Medical University
City
Jinzhou
State/Province
Liaoning
Country
China
Facility Name
Liaoyang Central Hospital
City
Liaoyang
State/Province
Liaoning
Country
China
Facility Name
Petrochemical General Hospital of Liaoyang city
City
Liaoyang
State/Province
Liaoning
Country
China
Facility Name
Third People's hospital Liaoyang
City
Liaoyang
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Liaoning Tumor Hospital & Institute
City
Shenyang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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