Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
NCT ID: NCT02203253
Last Updated: 2016-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
642 participants
INTERVENTIONAL
2014-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Thalidomide
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
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 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.
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
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.
Interventions
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Thalidomide
100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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The First Hospital of Liaoning Medical University
UNKNOWN
The First Affiliated Hospital of Dalian Medical University
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Shengjing Hospital
OTHER
General Hospital of Shenyang Military Region
OTHER
Liaoyang Central Hospital
OTHER
Third People's hospital Liaoyang
OTHER
Petrochemical General Hospital of Liaoyang city
UNKNOWN
Anshan Tumor Hospital
OTHER
China Medical University, China
OTHER
Responsible Party
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Yunpeng Liu
M.D.,PhD
Principal Investigators
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Yunpeng Liu, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
China Medical University, China
Locations
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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
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China
Countries
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Other Identifiers
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CLOG1302
Identifier Type: -
Identifier Source: org_study_id
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