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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Thalidomide Drug: Placebo for thalidomide Drug: Palonosetron and Dexamethasone Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Thalidomide
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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. complete response rate (CRR) for delayed CINV [ Time Frame: 120 hours ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 3 weeks ]
  2. quality of life [ Time Frame: up to 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203253


Locations
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China, Liaoning
Anshan Tumor Hospital
Anshan, Liaoning, China
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of Liaoning Medical University
Jinzhou, Liaoning, China
Liaoyang Central Hospital
Liaoyang, Liaoning, China
Petrochemical General Hospital of Liaoyang city
Liaoyang, Liaoning, China
Third People's hospital Liaoyang
Liaoyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China
Sponsors and Collaborators
China Medical University, China
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
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Principal Investigator: Yunpeng Liu, MD., PhD China Medical University, China
More Information
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Responsible Party: Yunpeng Liu, M.D.,PhD, China Medical University, China
ClinicalTrials.gov Identifier: NCT02203253    
Other Study ID Numbers: CLOG1302
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Yunpeng Liu, China Medical University, China:
solid tumor
chemotherapy-induced delayed nausea and vomiting
thalidomide
prevention
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Thalidomide
Dexamethasone
Palonosetron
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents