Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
- Conditions
- Neoplasms
- Interventions
- Registration Number
- NCT02203253
- Lead Sponsor
- China Medical University, China
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 642
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thalidomide Group Thalidomide 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 Group Placebo for thalidomide 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. Thalidomide Group Palonosetron and Dexamethasone 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 Group Palonosetron and Dexamethasone 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.
- Primary Outcome Measures
Name Time Method complete response rate (CRR) for delayed CINV 120 hours
- Secondary Outcome Measures
Name Time Method Adverse Events Up to 3 weeks quality of life up to 7 days
Trial Locations
- Locations (11)
The First Hospital of Liaoning Medical University
🇨🇳Jinzhou, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Petrochemical General Hospital of Liaoyang city
🇨🇳Liaoyang, Liaoning, China
Anshan Tumor Hospital
🇨🇳Anshan, Liaoning, China
Liaoning Tumor Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Third People's hospital Liaoyang
🇨🇳Liaoyang, Liaoning, China
General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Liaoyang Central Hospital
🇨🇳Liaoyang, Liaoning, China