The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy
Chemotherapy-induced Nausea and Vomiting
About this trial
This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring Thalidomide, Chemotherapy-induced Nausea and Vomiting, cisplatin
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;the patients and their couples should receive contraception for at least 3 years after their last dosage of thalidomide.
- Cancer patients scheduled to receive chemotherapy containing a 50 mg/m2 or higher dose of cisplatin for 4-6 cycles
Exclusion Criteria:
- Diabetic patients
- Pregnant or lactated women
- Patient with history of severe thrombosis
- Concomitant radiotherapy
- Known hypersensitivity yo 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
- Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (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
- cancer hospital of Haerbin Medical University
- Siping City Cancer Hospital
- Anshan Hospital of First Hospital of China Medical University
- Anshan Tumor Hospital
- Central hospital of Dalian
- Second Affiliated Hospital of Dalian Medical University
- The Fifth Hospital of Dalian City
- The First Affiliated Hospital of Dalian Medical University
- Zhuanghe Central Hospital
- Fushun Central HospitalRecruiting
- General Hospital of Mining Bureau
- Jinzhou Central Hospital
- The First Hospital of Liaoning Medical University
- Chinese Medicine Hospital of Liaoyang county
- Liaoyang Central Hospital
- Petrochemical General Hospital of Liaoyang city
- Panjin central Hospital
- Chest Hospital of Shenyang City
- Shengjing Hospital of China Medical University
- General Hospital of Shenyang Military Region
- Liaoning Tumor Hospital & Institute
- The First Hospital of China Medical UniversityRecruiting
- the People'S Hospital
- Tieling city Central Hospital
- Central Hospital of Anshan City
- Benxi Central Hospital
- Chaoyang Central Hospital
- Zhongshan Hospital
- Liaohe Oilfield General Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control group
Thalidomide group
Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4.
Thalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4.