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

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ClinicalTrials.gov Identifier: NCT02203253
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : August 24, 2016
Sponsor:
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
Information provided by (Responsible Party):
Yunpeng Liu, China Medical University, China

Tracking Information
First Submitted Date  ICMJE July 23, 2014
First Posted Date  ICMJE July 29, 2014
Last Update Posted Date August 24, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2014)
complete response rate (CRR) for delayed CINV [ Time Frame: 120 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2014)
  • Adverse Events [ Time Frame: Up to 3 weeks ]
  • quality of life [ Time Frame: up to 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • 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
    Other Name: Placebo tablet for thalidomide
  • 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.
Study Arms  ICMJE
  • Active Comparator: Thalidomide Group
    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.
    Interventions:
    • Drug: Thalidomide
    • Drug: Palonosetron and Dexamethasone
  • Placebo Comparator: Placebo Group
    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.
    Interventions:
    • Drug: Placebo for thalidomide
    • Drug: Palonosetron and Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
642
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2014)
820
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203253
Other Study ID Numbers  ICMJE CLOG1302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yunpeng Liu, China Medical University, China
Study Sponsor  ICMJE China Medical University, China
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Yunpeng Liu, MD., PhD China Medical University, China
PRS Account China Medical University, China
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP